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nasdaq:atra www.atarabio.com www.atarabio.com Jun 3rd, 2019 12:00AM Sr. Director, Quality Assurance Open Quality Assurance & Quality Control Thousand Oaks, CA, United States Thousand Oaks CA USA May 21st, 2019 12:00AM We launched Atara Biotherapeutics in August 2012 to help patients with serious diseases and few therapeutic options. We’re named after Atara Ciechanover who suffered from cancer before passing away. We are considered a leading off-the-shelf T-cell immunotherapy company (Nasdaq ATRA) developing novel treatments for patients with cancer, autoimmune and viral diseases.Position Summary:The Sr. Director, Quality Assurance provides GMP / GTP program & project leadership for Atara. This position interacts cross-functionally with Manufacturing, Supply Chain, Regulatory, Clinical Operations, Quality Control, Process Sciences, and Validation to ensure Quality objectives and initiatives are effectively delivered in a phase appropriate compliant manner. Primary Responsibilities:Lead implementation of Quality Assurance operational strategic initiatives, programs and processesEnsure timely notification and escalation of Quality related issues, and drives implementation of necessary remediation actions across the network.Partners with Quality leadership and cross functional colleagues to drive continuous improvement initiatives, and establish robust, compliant and scalable processes.Develop and establish standards and requirements, and provide oversight for, Viral Vector programLead the integration of phase appropriate quality requirements into business processes by partnering with cross functional leadersDevelop inspection (e.g., Pre-Licensure, Pre-Approval, etc.) strategies, working with inspection leads, and ensure effective cross functional execution against those strategiesEstablish standards and requirements for product Chain of Identity and Chain of Custody, both clinically and commercially.Core member of the Quality leadership Team Skills and Abilities:Demonstrated success in representing organizations during regulatory inspections (FDA, EMA, Health Canada) and with accreditation organizations (ISO, AATB, AABB), and internal auditsExperience leading the establishment of phase appropriate quality requirements and partnering cross functionally to integrate them into business processes for value chain (raw materials, vectors, starting materials, intermediates, and products)Experience setting standards and requirements for product Chain of identity and Chain of Custody (from apheresis centers to patient dosing, clinically and commercially)Experience establishing requirements for Apheresis centers, as well as establishing proper oversight and lifecycle managementExperience with GMP / GTP internal and external (outsourced activities and vendor) management and commercial readinessDemonstrated ability to work in a team environment to develop, implement and deliver on goalsDemonstrated ability to work successfully in a nimble fast paced matrixed environmentAbility to work both independently without supervision and be a part of a team, demonstrating excellent communication and interpersonal skillsStrong problem solving and analytical skills with demonstrated ability to be detail oriented; while managing multiple projects simultaneouslyMust be a strong leader and cross-functional team playerHigh bar personal ethics with a "patients first" value system. Education and Professional Experience:Bachelor’s Degree in engineering or Life Sciences or related discipline (graduate degree is preferred)15+ years of related quality operations experience in a GMP regulated Biologics or Pharmaceutical environmentExperience in a commercial phase pharmaceutical environmentExperience leading, coaching, inspiring, and developing staffDirect experience participating and supporting global (EMA, FDA, Health Canada) regulatory inspections and submissionsAdvanced knowledge of relevant regulations and regulatory guidance required to act as a resource for colleaguesMore About Atara Bio: Now in our sixth year, we’re proud of our team of 330+ Atarians co-located by design in South San Francisco (corporate headquarters) and Southern California (R&D and manufacturing headquarters in the northwest Los Angeles area) with a newly-established European headquarters in Zug, Switzerland. Atara also has a R&D site in the Denver, Colorado area and an office in New York City. Our Southern California hub is anchored by a new 90,000 sq. ft., state-of-the-art Atara T-Cell Operations and Manufacturing (ATOM) facility in Thousand Oaks, California.One mission – “Transform the lives of patients with serious medical conditions through pioneering science, teamwork and expertise” – and a singular vision – “Cell therapy treatment for every patient, any time – provide inspiration and direction for all of us.”The Company's off-the-shelf, allogeneic T-cells are bioengineered from donors with healthy immune function and allow for rapid delivery from inventory to patients without a requirement for pretreatment. Atara's T-cell immunotherapies are designed to precisely recognize and eliminate cancerous or diseased cells without affecting normal, healthy cells.Atara's most advanced T-cell immunotherapy in development, tabelecleucel, or tab-cel™ (formerly known as ATA129), is being developed for the treatment of patients with Epstein-Barr virus (EBV) associated post-transplant lymphoproliferative disorder (EBV+ PTLD) who have failed rituximab, as well as other EBV-associated hematologic and solid tumors, including nasopharyngeal carcinoma (NPC). Tab-cel™ is in Phase 3 clinical development for the treatment of EBV+ PTLD following an allogeneic hematopoietic cell transplant (MATCH study) or solid organ transplant (ALLELE study).Atara is also developing off-the-shelf, allogeneic ATA188 and autologous ATA190 T-cell immunotherapies using a complementary targeted antigen recognition technology for specific EBV antigens believed to be important for the potential treatment of multiple sclerosis (MS). A Phase 1 clinical study of autologous ATA190 in patients with progressive MS is ongoing. Atara is also advancing a Phase 1 clinical study of ATA188 in patients with progressive or relapsing-remitting MS across clinical sites in the United States and Australia. Atara's clinical pipeline also includes ATA520 targeting Wilms Tumor 1 (WT1) and ATA230 directed against cytomegalovirus (CMV).Working at Atara Bio: People at Atara Bio are high integrity, roll-up-your-sleeves, get-it-done types who are keenly committed to putting patients first, advancing medical care and doing so with demonstrated urgency. At their core Atarians are people who work well with others and are “team-centric”, have purposeful curiosity and can’t wait to save patient lives. And similar to other biotech companies who have so many accomplished people, we expect humility (we are a “low hubris” sort of place), flexibility, respect, teamwork, good judgment and getting the most out of any dollar we spend. We also expect to enjoy the journey (and each other) as we move forward with a shared responsibility to teach and to learn from what we do and from our teammates.Atara Bio is an equal opportunity employer and makes employment decisions on the basis of merit and other lawful factors. In accordance with applicable law, the Company prohibits discrimination based on race, color, religion, creed, sex, gender (including pregnancy, childbirth or medical condition related to pregnancy or childbirth), gender identity, expression or dysphoria, marital status, age, national origin or ancestry, physical or mental disability, medical condition, genetic information, veteran status, caregiver status, sexual orientation, transgender status or any other classification protected by federal, state or local laws or because of the individual’s association with a member of a protected group or connection to an organization or group related to a protected group.We comply with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Atara Bio in the United States. Jun 2nd, 2019 11:12PM Jun 2nd, 2019 11:12PM Health Care Pharmaceuticals & Biotechnology
nasdaq:atra www.atarabio.com www.atarabio.com Jun 3rd, 2019 12:00AM Director, Talent Acquisition Open Human Resources Thousand Oaks, CA, United States Thousand Oaks CA USA May 22nd, 2019 12:00AM We launched Atara Biotherapeutics in August 2012 to help patients with serious diseases and few therapeutic options. We’re named after Atara Ciechanover who suffered from cancer before passing away. We are considered a leading off-the-shelf T-cell immunotherapy company (Nasdaq ATRA) developing novel treatments for patients with cancer, autoimmune and viral diseases.Summary Description This key role is responsible for extending and growing an organization that has a culture of patients first, sense of urgency, high ethics. and values roll-your-sleeves up get it done teamwork.   In conjunction with the VP, Talent Acquisition & Management, this person will be the point for the hiring of our new T-cell manufacturing site as well as enterprise-wide hires needed to evolve the company from a development organization into a global commercial company. Reports to:         Vice President, Talent Acquisition & ManagementLocation:             Thousand Oaks, CA (northwest Los Angeles)  Position Responsibilities:Collaborates with functions and leads to help build/support a talent acquisition function that views culture (and talent acquisition and retention) as a significant critical business advantage.Helps design and co-leads the development of both short and long-term staffing strategies and tactics. Able to balance day to day tactics with a shared longer term vision for the function and the company.Full life cycle recruiting; works closely with hiring managers to edit/write position descriptions, establish position criteria and qualifications, helps price roles with HR Ops, establishes interviewing participants and process, oversees job postings and candidate outreach, initially screen and interview candidates, and helps manage the candidate process to completion.Sources, screens, interviews and cultivates candidates.Partners closely and effectively with other Atara Bio HR team members (both senior, peer and junior.)Manages external talent acquisition resources (search firms, sourcing resources) to optimize effective and efficient talent placement.Serves as a culture and talent maven. Able to come up to speed to assess, identify and promote the candidates most likely to succeed in a team-centric, patients first, roll up your sleeves, sense of urgency culture and organization.Builds and leverages an understanding of Atara brand and culture, company development cycle and talent market to inform recruiting strategy and execution in order to compete effectively and differentiate our Company Travel:                  Travel will be required (up to 20%) Physical Requirements:Subject to extended periods of sitting and/or standing, vision to monitor and moderate noise levels. Work is generally performed in an office or clinical environment. Car and airplane travel is an essential part of the job. Qualifications:Minimum of 10 years’ professional experience in a talent acquisition, talent management or human resources role, including 6 years in a recruitment role.Must have 5-7 years of bio-pharma experience.Demonstrated success in developing and executing hiring plans with the ability to strategically plan and execute initiatives across the organization.Fluency in applicant tracking systems and online sourcing networks is required.Strong contracting and consulting skills with a proven track record influencing hiring manager at multiple levels in an organization.Prior experience in 3rd-party vendor management.Strong track record of success in a team-centric, non-hierarchical fast paced environment.Excellent written and verbal communication skills with employees at all levels of the organization.Excellent interpersonal and teaming skills with a demonstrated track record to reach effective outcomes.A data-driven person with a “can do” attitude and willingness to do the work.High bar personal ethics with a “patients first” value system.Role model for Atara values. Education:Bachelor’s Degree required, strongly preferred in natural or life sciences. Graduate degrees preferred.More About Atara BioNow in our sixth year, we’re proud of our team of 260+ Atarians co-located by design in South San Francisco (corporate headquarters) and Southern California (R&D and manufacturing headquarters in the northwest Los Angeles area) with a newly-established European headquarters in Zug, Switzerland. Atara also has a R&D site in the Denver, Colorado area and an office in New York City. Our Southern California hub is anchored by a new 90,000 sq. ft., state-of-the-art Atara T-Cell Operations and Manufacturing (ATOM) facility in Thousand Oaks, California.One mission – “Transform the lives of patients with serious medical conditions through pioneering science, teamwork and expertise” – and a singular vision – “Cell therapy treatment for every patient, any time – provide inspiration and direction for all of us.”The Company's off-the-shelf, allogeneic T-cells are bioengineered from donors with healthy immune function and allow for rapid delivery from inventory to patients without a requirement for pretreatment. Atara's T-cell immunotherapies are designed to precisely recognize and eliminate cancerous or diseased cells without affecting normal, healthy cells.Atara's most advanced T-cell immunotherapy in development, tabelecleucel, or tab-cel™ (formerly known as ATA129), is being developed for the treatment of patients with Epstein-Barr virus (EBV) associated post-transplant lymphoproliferative disorder (EBV+ PTLD) who have failed rituximab, as well as other EBV-associated hematologic and solid tumors, including nasopharyngeal carcinoma (NPC). Tab-cel™ is in Phase 3 clinical development for the treatment of EBV+ PTLD following an allogeneic hematopoietic cell transplant (MATCH study) or solid organ transplant (ALLELE study).Atara is also developing off-the-shelf, allogeneic ATA188 and autologous ATA190 T-cell immunotherapies using a complementary targeted antigen recognition technology for specific EBV antigens believed to be important for the potential treatment of multiple sclerosis (MS). A Phase 1 clinical study of autologous ATA190 in patients with progressive MS is ongoing. Atara is also advancing a Phase 1 clinical study of ATA188 in patients with progressive or relapsing-remitting MS across clinical sites in the United States and Australia. Atara's clinical pipeline also includes ATA520 targeting Wilms Tumor 1 (WT1) and ATA230 directed against cytomegalovirus (CMV). Working at Atara BioPeople at Atara Bio are high integrity, roll-up-your-sleeves, get-it-done types who are keenly committed to putting patients first, advancing medical care and doing so with demonstrated urgency. At their core Atarians are people who work well with others and are “team-centric”, have purposeful curiosity and can’t wait to save patient lives. And similar to other biotech companies who have so many accomplished people, we expect humility (we are a “low hubris” sort of place), flexibility, respect, teamwork, good judgment and getting the most out of any dollar we spend. We also expect to enjoy the journey (and each other) as we move forward with a shared responsibility to teach and to learn from what we do and from our teammates.Atara Bio is an equal opportunity employer and makes employment decisions on the basis of merit and other lawful factors. In accordance with applicable law, the Company prohibits discrimination based on race, color, religion, creed, sex, gender (including pregnancy, childbirth or medical condition related to pregnancy or childbirth), gender identity, expression or dysphoria, marital status, age, national origin or ancestry, physical or mental disability, medical condition, genetic information, veteran status, caregiver status, sexual orientation, transgender status or any other classification protected by federal, state or local laws or because of the individual’s association with a member of a protected group or connection to an organization or group related to a protected group.We comply with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Atara Bio in the United States. Jun 2nd, 2019 11:12PM Jun 2nd, 2019 11:12PM Health Care Pharmaceuticals & Biotechnology
nasdaq:atra www.atarabio.com www.atarabio.com Jun 3rd, 2019 12:00AM Director Regulatory Affairs Open Regulatory Affairs Thousand Oaks, CA, United States Thousand Oaks CA USA May 22nd, 2019 12:00AM We launched Atara Biotherapeutics in August 2012 to help patients with serious diseases and few therapeutic options. We’re named after Atara Ciechanover who suffered from cancer before passing away. We are considered a leading off-the-shelf T-cell immunotherapy company (Nasdaq ATRA) developing novel treatments for patients with cancer, autoimmune and viral diseases.Position SummaryThis position supports all regulatory affairs activities for the company’s products, including but not limited to collecting and summarizing regulatory intelligence, performing regulatory assessments, participation in project teams, providing input for regulatory submissions, and managing the compilation and review of all submissions for completeness and quality. Reports to:  Senior Director, Regulatory AffairsLocation:  Thousand Oaks, CA Primary Responsibilities:Manages regulatory projects and closely collaborates with Clinical, Regulatory Operations, other scientific and technical departments and external vendors to coordinate and implement submission strategy and content in a global clinical biopharmaceutical development environment.Provides updates on strategic regulatory intelligence, such as new regulations, guidance, ODACs, competitive product applications and approvals, etc.Provides regulatory intelligence to inform regulatory strategies, including scenarios for the earliest regulatory approvals possible as well as an assessment of risk for each of the various scenarios.Provides tactical support for the timely preparation, editing and review of submissions, including regulatory agency Meeting Requests and Briefing Documents, IND/CTA amendments, original BLAs and international Marketing Authorization Applications and their respective amendments/supplements.Coordinates and manages regulatory submission documents (e.g., cover letters, Meeting Requests, Meeting Briefing Packages, etc.) to produce submission ready content. Coordinate interdepartmental team review and approval of submission document deliverables including: distribute drafts, attend/steer review meetings, and incorporate revisions.Manages the quality, accuracy, compliance with internal and external standards, and the timely production of submission documents using manual and electronic document management systems such as Veeva, as appropriate.Works with Regulatory Operations or publishing vendors to compile and review regulatory submissions for completeness and quality, ensuring that Atara’s practices are in conformance with the latest health authority and industry submission standards.Assists with logging, tracking and filing of correspondence with regulatory authorities and ensuring that no commitment remains unduly outstanding.While primarily focused on clinical regulatory activities, CMC regulatory support may also be needed. Travel:  Travel may be required (up to 10%).Physical Requirements:  Subject to extended periods of sitting and standing, vision to monitor and moderate noise levels. Work is performed in an office environment.  Position Requirements:Takes ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance, as necessary.Understands and interprets data/information and its practical application.Strong communication skills (e.g., clear and concise), team player, and proven negotiation skills.Strong understanding of pharmaceutical biologics drug development, clinical research, study design, biostatistics, pharmacokinetics, the regulatory environment, project management, and medical terminology.Working knowledge of manufacturing research and development. CMC regulatory experience, and/or knowledge of cellular therapies manufacturing, and quality development would be an advantage.Strong time and project management skills.Strong critical and logical thinking with ability to analyze problems, identify alternative solutions, and implement recommendations for resolution.Self-motivated, flexible and creative leader, able to prioritize, multi-task, and work in a fast-paced & demanding environment.Role model for Atara’s Values of patients first, innovation teamwork, community and mindset.Education and Professional ExperienceBachelor’s degree (MS, PhD, PharmD preferred), in Life Sciences/Health Related field, from an accredited college or university with 15 or more years drug development or related experience with 7+ years in Regulatory Affairs.Extensive knowledge of regulatory requirements.Proficient in pertinent software & tools.Must be knowledgeable in industry trends for study reports and dossier preparation (e.g., IND/CTA/NDA/NDS), including electronic document submissions (i.e., eCTD). More About Atara Bio:Now in our sixth year, we’re proud of our team of 300+ Atarians co-located by design in South San Francisco (corporate headquarters) and Southern California (R&D and manufacturing headquarters in the northwest Los Angeles area) with a newly-established European headquarters in Zug, Switzerland. Atara also has a R&D site in the Denver, Colorado area and an office in New York City. Our Southern California hub is anchored by a new 90,000 sq. ft., state-of-the-art Atara T-Cell Operations and Manufacturing (ATOM) facility in Thousand Oaks, California.One mission – “Transform the lives of patients with serious medical conditions through pioneering science, teamwork and expertise” – and a singular vision – “Cell therapy treatment for every patient, any time – provide inspiration and direction for all of us.”The Company's off-the-shelf, allogeneic T-cells are bioengineered from donors with healthy immune function and allow for rapid delivery from inventory to patients without a requirement for pretreatment. Atara's T-cell immunotherapies are designed to precisely recognize and eliminate cancerous or diseased cells without affecting normal, healthy cells.Atara's most advanced T-cell immunotherapy in development, tabelecleucel, or tab-cel™ (formerly known as ATA129), is being developed for the treatment of patients with Epstein-Barr virus (EBV) associated post-transplant lymphoproliferative disorder (EBV+ PTLD) who have failed rituximab, as well as other EBV-associated hematologic and solid tumors, including nasopharyngeal carcinoma (NPC). Tab-cel™ is in Phase 3 clinical development for the treatment of EBV+ PTLD following an allogeneic hematopoietic cell transplant (MATCH study) or solid organ transplant (ALLELE study).Atara is also developing off-the-shelf, allogeneic ATA188 and autologous ATA190 T-cell immunotherapies using a complementary targeted antigen recognition technology for specific EBV antigens believed to be important for the potential treatment of multiple sclerosis (MS). A Phase 1 clinical study of autologous ATA190 in patients with progressive MS is ongoing. Atara is also advancing a Phase 1 clinical study of ATA188 in patients with progressive or relapsing-remitting MS across clinical sites in the United States and Australia. Atara's clinical pipeline also includes ATA520 targeting Wilms Tumor 1 (WT1) and ATA230 directed against cytomegalovirus (CMV). Working at Atara Bio:People at Atara Bio are high integrity, roll-up-your-sleeves, get-it-done types who are keenly committed to putting patients first, advancing medical care and doing so with demonstrated urgency. At their core Atarians are people who work well with others and are “team-centric”, have purposeful curiosity and can’t wait to save patient lives. And similar to other biotech companies who have so many accomplished people, we expect humility (we are a “low hubris” sort of place), flexibility, respect, teamwork, good judgment and getting the most out of any dollar we spend. We also expect to enjoy the journey (and each other) as we move forward with a shared responsibility to teach and to learn from what we do and from our teammates. Atara Bio is an equal opportunity employer and makes employment decisions on the basis of merit and other lawful factors. In accordance with applicable law, the Company prohibits discrimination based on race, color, religion, creed, sex, gender (including pregnancy, childbirth or medical condition related to pregnancy or childbirth), gender identity, expression or dysphoria, marital status, age, national origin or ancestry, physical or mental disability, medical condition, genetic information, veteran status, caregiver status, sexual orientation, transgender status or any other classification protected by federal, state or local laws or because of the individual’s association with a member of a protected group or connection to an organization or group related to a protected group.We comply with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Atara Bio in the United States. Jun 2nd, 2019 11:12PM Jun 2nd, 2019 11:12PM Health Care Pharmaceuticals & Biotechnology
nasdaq:atra www.atarabio.com www.atarabio.com Jun 3rd, 2019 12:00AM Senior Manager Regulatory Affairs - CMC Open Regulatory Affairs Thousand Oaks, CA, United States Thousand Oaks CA USA May 22nd, 2019 12:00AM We launched Atara Biotherapeutics in August 2012 to help patients with serious diseases and few therapeutic options. We’re named after Atara Ciechanover who suffered from cancer before passing away. We are considered a leading off-the-shelf T-cell immunotherapy company (Nasdaq ATRA) developing novel treatments for patients with cancer, autoimmune and viral diseases.Position Summary:This position supports all CMC regulatory affairs activities for the company’s products and research, summarize regulatory intelligence, provides CMC regulatory input for regulatory submissions, and manages the compilation and review of CMC sections of all submissions for completeness and quality. Reports to:  Associate Director, Regulatory Affairs CMCLocation:  Thousand Oaks (northwest Los Angeles area), CA.Primary Responsibilities:Provide tactical support for the timely preparation, editing and review of submissions, including regulatory agency Meeting Requests and Briefing Documents, IND/CTA amendments, original Marketing Authorization Applications and their respective amendments/supplements.Manage assigned regulatory projects and closely collaborate with personnel from Clinical, Regulatory Operations, other scientific departments and external vendors to coordinate and implement submission strategy and content in a global clinical development environment.Provide updates on strategic global regulatory intelligence, such as new regulations, guidance, ODACs, competitive product applications and approvals, etc.Identify and draft necessary SOPs and/or Work Instructions for Regulatory Affairs.Contribute to the creation and maintenance of a Target Product Profile and Company Core Data Sheet.Provide US regulatory intelligence to project specific regulatory strategies, including scenarios for the earliest regulatory approvals possible as well as an assessment of risk for each of the various scenarios.Coordinate and manage regulatory submission documents (e.g., cover letters, Meeting Requests, Meeting Briefing Packages, etc.) to produce submission ready content (SRC).Manage the quality, accuracy, compliance with internal and external standards, and the timely production of submission documents using manual and electronic document management systems, as appropriate.Coordinate interdepartmental team review and approval of submission document deliverables including: distribute drafts, attend review meetings, and incorporate revisions.Work with Regulatory Operations or publishing vendors to compile and review regulatory submissions for completeness and quality, ensuring that Atara’s practices are in conformance with the latest health authority and industry submission standards.Assist with logging, tracking and filing of correspondence with regulatory authorities and ensuring that no commitment remains unduly outstanding.Review documents in change control in order to ensure that they meet regulatory requirements.Perform other related duties as assigned. Travel:  Travel may be required (up to 25%).Physical Requirements:  Subject to extended periods of sitting and standing, vision to monitor and moderate noise levels. Work is performed in an office environment.Position Requirements:Strong communication skills (e.g., clear and concise), team player, proven negotiation skills.Ability to manage and motivate staff.Strong understanding of pharmaceutical development, clinical research, study design, biostatistics, pharmacokinetics, the regulatory environment, project management, and medical terminology.Strong time and project management skills.Strong critical and logical thinking with ability to analyze problems, identify alternative solutions, and implement recommendations for resolution.Self-motivated, flexible and creative leader, able to prioritize, multi-task, and work in a fast-paced & demanding environment.Able to take ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance, as necessary.Able to understand and interpret data/information and its practical application. Education and Professional Experience:Minimum of a Bachelor's degree, preferably in Sciences/Health Related Sciences, from an accredited college or university.Approximately 4-8 years of related pharmaceutical or biopharmaceutical industry experience, with at least 3 of those years directly in regulatory affairs.Extensive knowledge of regulatory requirements.Experience with cell and gene therapy products preferredProficient in pertinent software & tools.Must be knowledgeable in industry trends for study reports and dossier preparation (e.g., IND/CTA/NDA/NDS), including electronic document submissions (i.e., eCTD).More About Atara Bio: Now in our sixth year, we’re proud of our team of 300+ Atarians co-located by design in South San Francisco (corporate headquarters) and Southern California (R&D and manufacturing headquarters in the northwest Los Angeles area) with a newly-established European headquarters in Zug, Switzerland. Atara also has a R&D site in the Denver, Colorado area and an office in New York City. Our Southern California hub is anchored by a new 90,000 sq. ft., state-of-the-art Atara T-Cell Operations and Manufacturing (ATOM) facility in Thousand Oaks, California.One mission – “Transform the lives of patients with serious medical conditions through pioneering science, teamwork and expertise” – and a singular vision – “Cell therapy treatment for every patient, any time – provide inspiration and direction for all of us.”The Company's off-the-shelf, allogeneic T-cells are bioengineered from donors with healthy immune function and allow for rapid delivery from inventory to patients without a requirement for pretreatment. Atara's T-cell immunotherapies are designed to precisely recognize and eliminate cancerous or diseased cells without affecting normal, healthy cells.Atara's most advanced T-cell immunotherapy in development, tabelecleucel, or tab-cel™ (formerly known as ATA129), is being developed for the treatment of patients with Epstein-Barr virus (EBV) associated post-transplant lymphoproliferative disorder (EBV+ PTLD) who have failed rituximab, as well as other EBV-associated hematologic and solid tumors, including nasopharyngeal carcinoma (NPC). Tab-cel™ is in Phase 3 clinical development for the treatment of EBV+ PTLD following an allogeneic hematopoietic cell transplant (MATCH study) or solid organ transplant (ALLELE study).Atara is also developing off-the-shelf, allogeneic ATA188 and autologous ATA190 T-cell immunotherapies using a complementary targeted antigen recognition technology for specific EBV antigens believed to be important for the potential treatment of multiple sclerosis (MS). A Phase 1 clinical study of autologous ATA190 in patients with progressive MS is ongoing. Atara is also advancing a Phase 1 clinical study of ATA188 in patients with progressive or relapsing-remitting MS across clinical sites in the United States and Australia. Atara's clinical pipeline also includes ATA520 targeting Wilms Tumor 1 (WT1) and ATA230 directed against cytomegalovirus (CMV).Working at Atara Bio: People at Atara Bio are high integrity, roll-up-your-sleeves, get-it-done types who are keenly committed to putting patients first, advancing medical care and doing so with demonstrated urgency. At their core Atarians are people who work well with others and are “team-centric”, have purposeful curiosity and can’t wait to save patient lives. And similar to other biotech companies who have so many accomplished people, we expect humility (we are a “low hubris” sort of place), flexibility, respect, teamwork, good judgment and getting the most out of any dollar we spend. We also expect to enjoy the journey (and each other) as we move forward with a shared responsibility to teach and to learn from what we do and from our teammates.Atara Bio is an equal opportunity employer and makes employment decisions on the basis of merit and other lawful factors. In accordance with applicable law, the Company prohibits discrimination based on race, color, religion, creed, sex, gender (including pregnancy, childbirth or medical condition related to pregnancy or childbirth), gender identity, expression or dysphoria, marital status, age, national origin or ancestry, physical or mental disability, medical condition, genetic information, veteran status, caregiver status, sexual orientation, transgender status or any other classification protected by federal, state or local laws or because of the individual’s association with a member of a protected group or connection to an organization or group related to a protected group.We comply with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Atara Bio in the United States. Jun 2nd, 2019 11:12PM Jun 2nd, 2019 11:12PM Health Care Pharmaceuticals & Biotechnology
nasdaq:atra www.atarabio.com www.atarabio.com Jun 3rd, 2019 12:00AM Senior Director Regulatory Affairs CMC Open Regulatory Affairs Westlake Village (Los Angeles), CA, United States Westlake Village CA USA May 22nd, 2019 12:00AM We launched Atara Biotherapeutics in August 2012 to help patients with serious diseases and few therapeutic options. We’re named after Atara Ciechanover who suffered from cancer before passing away. We are considered a leading off-the-shelf T-cell immunotherapy company (Nasdaq ATRA) developing novel treatments for patients with cancer, autoimmune and viral diseases.Position SummaryThis position supports all CMC regulatory affairs activities for the company’s products and research, provides CMC regulatory input for regulatory strategies and RA CMC leadership within regulatory and on cross-functional CMC teams.Reports to:  Vice President Regulatory Affairs CMCLocation:  Thousand Oaks, CA (northwest Los Angeles area), CAPrimary Responsibilities:Leads the development of competitive global regulatory strategies.Provides strategic and tactical support for the timely preparation, editing and review of submissions, including regulatory agency Meeting Requests and Briefing Documents, IND/CTA amendments, original Marketing Authorization Applications and their respective amendments/supplements.Manages assigned regulatory projects and closely collaborate with personnel from Clinical, Regulatory Operations, other scientific departments and external vendors to coordinate and implement submission strategy and content in a global clinical development environment.Serves as a liaison between the regulatory authorities and the company on CMC issues, successfully prepare teams, lead regulatory agency meetings.Manages the quality, accuracy, compliance with internal and external standards, and the timely production of submission documents using manual and electronic document management systems, as appropriate.Provides updates on strategic global regulatory intelligence, such as new regulations, guidance, ODACs, competitive product applications and approvals, etc.Identifies and drafts necessary SOPs and/or Work Instructions for Regulatory Affairs.Contributes to the creation and maintenance of a Target Product Profile and Company Core Data Sheet.Provides regulatory intelligence to project specific regulatory strategies, including scenarios for the earliest regulatory approvals possible as well as an assessment of risk for each of the various scenarios.Leads interdepartmental team review and approval of submission document deliverables including: distribute drafts, attend review meetings, and incorporate revisions.Collaborates with Regulatory Operations or publishing vendors to ensure that Atara’s practices are in conformance with the latest health authority and industry submission standards.Ensures logging, tracking and filing of correspondence with regulatory authorities and ensuring that no commitment remains unduly outstanding.Assists the teams with change control assessment in order to ensure that they meet regulatory requirements.Hires, leads, mentors and develops a team of direct reports.Performs other related duties as assigned.  Travel:  Travel may be required (up to 25%)Physical Requirements: Subject to extended periods of sitting and standing, vision to monitor and moderate noise levels. Work is performed in an office environment.Position Requirements:Strong leadership and management skills.Strong communication skills (e.g., clear and concise), team player, proven negotiation skills.Ability to manage and motivate staff.Demonstrated experience with global development, registration and post-approval submissions.Strong understanding of pharmaceutical development, clinical research, study design, biostatistics, pharmacokinetics, the regulatory environment, project management, and medical terminology.Strong time and project management skills.Strong critical and logical thinking with ability to analyze problems, identify alternative solutions, and implement recommendations for resolution.Self-motivated, flexible and creative leader, able to prioritize, multi-task, and work in a fast-paced & demanding environment.Able to take ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance, as necessary.Able to work in a fast-paced environment.Able to understand and interpret data/information and its practical application.Experience with hiring, coaching, developing and leading a team.Extensive knowledge of US and international regulatory requirements.Proficient in pertinent software & tools.Strong collaboration and cross-functional partnership building.Role model for Atara’s Values of patients first, innovation teamwork, community and mindset.Education and Professional ExperienceMinimum of a Bachelor's degree, preferably in Sciences/Health Related Sciences, from an accredited college or university.15 or more years of related pharmaceutical or biopharmaceutical industry experience, with at least 10 of those years directly in regulatory affairs.Must be knowledgeable in industry trends for study reports and global dossier preparation (e.g., IND/CTA/NDA/BLA/NDS), including electronic document submissions (i.e., eCTD). More About Atara Bio: Now in our sixth year, we’re proud of our team of 300+ Atarians co-located by design in South San Francisco (corporate headquarters) and Southern California (R&D and manufacturing headquarters in the northwest Los Angeles area) with a newly-established European headquarters in Zug, Switzerland. Atara also has a R&D site in the Denver, Colorado area and an office in New York City. Our Southern California hub is anchored by a new 90,000 sq. ft., state-of-the-art Atara T-Cell Operations and Manufacturing (ATOM) facility in Thousand Oaks, California.One mission – “Transform the lives of patients with serious medical conditions through pioneering science, teamwork and expertise” – and a singular vision – “Cell therapy treatment for every patient, any time – provide inspiration and direction for all of us.”The Company's off-the-shelf, allogeneic T-cells are bioengineered from donors with healthy immune function and allow for rapid delivery from inventory to patients without a requirement for pretreatment. Atara's T-cell immunotherapies are designed to precisely recognize and eliminate cancerous or diseased cells without affecting normal, healthy cells.Atara's most advanced T-cell immunotherapy in development, tabelecleucel, or tab-cel™ (formerly known as ATA129), is being developed for the treatment of patients with Epstein-Barr virus (EBV) associated post-transplant lymphoproliferative disorder (EBV+ PTLD) who have failed rituximab, as well as other EBV-associated hematologic and solid tumors, including nasopharyngeal carcinoma (NPC). Tab-cel™ is in Phase 3 clinical development for the treatment of EBV+ PTLD following an allogeneic hematopoietic cell transplant (MATCH study) or solid organ transplant (ALLELE study).Atara is also developing off-the-shelf, allogeneic ATA188 and autologous ATA190 T-cell immunotherapies using a complementary targeted antigen recognition technology for specific EBV antigens believed to be important for the potential treatment of multiple sclerosis (MS). A Phase 1 clinical study of autologous ATA190 in patients with progressive MS is ongoing. Atara is also advancing a Phase 1 clinical study of ATA188 in patients with progressive or relapsing-remitting MS across clinical sites in the United States and Australia. Atara's clinical pipeline also includes ATA520 targeting Wilms Tumor 1 (WT1) and ATA230 directed against cytomegalovirus (CMV).Working at Atara Bio: People at Atara Bio are high integrity, roll-up-your-sleeves, get-it-done types who are keenly committed to putting patients first, advancing medical care and doing so with demonstrated urgency. At their core Atarians are people who work well with others and are “team-centric”, have purposeful curiosity and can’t wait to save patient lives. And similar to other biotech companies who have so many accomplished people, we expect humility (we are a “low hubris” sort of place), flexibility, respect, teamwork, good judgment and getting the most out of any dollar we spend. We also expect to enjoy the journey (and each other) as we move forward with a shared responsibility to teach and to learn from what we do and from our teammates.Atara Bio is an equal opportunity employer and makes employment decisions on the basis of merit and other lawful factors. In accordance with applicable law, the Company prohibits discrimination based on race, color, religion, creed, sex, gender (including pregnancy, childbirth or medical condition related to pregnancy or childbirth), gender identity, expression or dysphoria, marital status, age, national origin or ancestry, physical or mental disability, medical condition, genetic information, veteran status, caregiver status, sexual orientation, transgender status or any other classification protected by federal, state or local laws or because of the individual’s association with a member of a protected group or connection to an organization or group related to a protected group.We comply with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Atara Bio in the United States. Jun 2nd, 2019 11:12PM Jun 2nd, 2019 11:12PM Health Care Pharmaceuticals & Biotechnology
nasdaq:atra www.atarabio.com www.atarabio.com Jun 3rd, 2019 12:00AM Clinical Trials Manager Open Clinical Science Westlake Village (Los Angeles), CA, United States Westlake Village CA USA May 23rd, 2019 12:00AM We launched Atara Biotherapeutics in August 2012 to help patients with serious diseases and few therapeutic options. We’re named after Atara Ciechanover who suffered from cancer before passing away. We are considered a leading off-the-shelf T-cell immunotherapy company (Nasdaq ATRA) developing novel treatments for patients with cancer, autoimmune and viral diseases.Position SummaryThe Clinical Trials Manager is responsible for the execution of clinical trials from typically works on studies with moderate to high complexity (in terms of design, location, phase, etc.), and proactively identifies and resolves clinical project issues and participates in process improvement initiatives as required.  Report to     Director, Clinical OpsLocation      Westlake Village (NW Los Angeles) preferred or South San Francisco, CAPrimary Responsibilities:Manages all clinical aspects of study, including: assesses operational feasibility and recommends study execution plans; manages study timelines and metrics; participates in selection and management/oversight of external vendors and develops vendor specifications; reviews vendor reports, budgets, and metrics; provides study-specific training and leadership to clinical research staff, including CRO, CRAs, sites and other contract personnel; prepares and presents project debriefings, as required; plans, executes, and attends/manages study-specific meetings (e.g., Study Management Meetings, investigator meetings, etc.) as applicable; participates in site monitoring visits as appropriate.Uses operational and therapeutic expertise to optimize trial design and execution: works with the study team to design clinical trial protocols and assists in developing/managing an ongoing data review plan to ensure detection of data trends and to ensure study objectives are met; prepares study-related documentation; supports the creation of the ICF template, CRFs, etc.Prepares and/or reviews study-related documents (e.g., Monitoring Plan, Laboratory Manual, Patient Diary, Pharmacy Manual, and CRF Completion Guidelines, etc.).Prepares/reviews site study documents (i.e., site-specific informed consent, study tools/worksheets, investigator contracts, and site payments).Selects sites and countries; develops relationships with investigators and site staff.Assists in development and management of study budget and maintains it within financial goals; reviews and approves clinical invoices against approved budget.Ensures all clinical trials are executed in compliance with ICH/GCP guidelines/regulations and applicable SOPs: participates in the planning of quality assurance activities and coordinates resolution of audit findings; ensures audit-ready condition of clinical trial documentation including central clinical files; reviews monitoring reports to ensure quality and resolution of site-related issues; coordinates and assists in the planning of regulatory or ethics committee activities, as appropriate.Interface with cross-functional teams (e.g. Medical Monitor, Regulatory Affairs, CRO, vendors and Investigators/site staff).Manages clinical monitoring activities (including approval of visit report templates, monitoring plan, etc.) ensuring compliance with ICH/GCP and applicable regulations. Includes management through resolution (CAPA) of any site or study level issues, deviations, etc.Participates in the selection, training, and evaluation of study personnel (contract and internal) to ensure the efficient operation of the function. Travel:                                    Travel may be required (up to 25%).Physical RequirementsSubject to extended periods of sitting and standing, vision to monitor and moderate noise levels. Work is generally performed in an office or clinical environment. Car and airplane (see above) travel is an essential part of the job. Education & Professional ExperienceRequired:Bachelor's degree or equivalent combination of education/experience in science or health-related field required.Minimum of 7 years of clinical trial experience required 5 of which would preferrably be within either the pharmaceuticals or biotechnology.Strong understanding of ICH/GCP, and knowledge of regulatory requirements.Strong clinical study management skills.Excellent communication and organizational skills, along with problem solving, conflict resolution, leadership and team-building skills.Preferred:Neurology, CNS and Oncology experienceGlobal trial management experienceMore About Atara BioNow in our sixth year, we’re proud of our team of 260+ Atarians co-located by design in South San Francisco (corporate headquarters) and Southern California (R&D and manufacturing headquarters in the northwest Los Angeles area) with a newly-established European headquarters in Zug, Switzerland. Atara also has a R&D site in the Denver, Colorado area and an office in New York City. Our Southern California hub is anchored by a new 90,000 sq. ft., state-of-the-art Atara T-Cell Operations and Manufacturing (ATOM) facility in Thousand Oaks, California.One mission – “Transform the lives of patients with serious medical conditions through pioneering science, teamwork and expertise” – and a singular vision – “Cell therapy treatment for every patient, any time – provide inspiration and direction for all of us.”The Company's off-the-shelf, allogeneic T-cells are bioengineered from donors with healthy immune function and allow for rapid delivery from inventory to patients without a requirement for pretreatment. Atara's T-cell immunotherapies are designed to precisely recognize and eliminate cancerous or diseased cells without affecting normal, healthy cells.Atara's most advanced T-cell immunotherapy in development, tabelecleucel, or tab-cel™ (formerly known as ATA129), is being developed for the treatment of patients with Epstein-Barr virus (EBV) associated post-transplant lymphoproliferative disorder (EBV+ PTLD) who have failed rituximab, as well as other EBV-associated hematologic and solid tumors, including nasopharyngeal carcinoma (NPC). Tab-cel™ is in Phase 3 clinical development for the treatment of EBV+ PTLD following an allogeneic hematopoietic cell transplant (MATCH study) or solid organ transplant (ALLELE study).Atara is also developing off-the-shelf, allogeneic ATA188 and autologous ATA190 T-cell immunotherapies using a complementary targeted antigen recognition technology for specific EBV antigens believed to be important for the potential treatment of multiple sclerosis (MS). A Phase 1 clinical study of autologous ATA190 in patients with progressive MS is ongoing. Atara is also advancing a Phase 1 clinical study of ATA188 in patients with progressive or relapsing-remitting MS across clinical sites in the United States and Australia. Atara's clinical pipeline also includes ATA520 targeting Wilms Tumor 1 (WT1) and ATA230 directed against cytomegalovirus (CMV).Working at Atara BioPeople at Atara Bio are high integrity, roll-up-your-sleeves, get-it-done types who are keenly committed to putting patients first, advancing medical care and doing so with demonstrated urgency. At their core Atarians are people who work well with others and are “team-centric”, have purposeful curiosity and can’t wait to save patient lives. And similar to other biotech companies who have so many accomplished people, we expect humility (we are a “low hubris” sort of place), flexibility, respect, teamwork, good judgment and getting the most out of any dollar we spend. We also expect to enjoy the journey (and each other) as we move forward with a shared responsibility to teach and to learn from what we do and from our teammates.Atara Bio is an equal opportunity employer and makes employment decisions on the basis of merit and other lawful factors. In accordance with applicable law, the Company prohibits discrimination based on race, color, religion, creed, sex, gender (including pregnancy, childbirth or medical condition related to pregnancy or childbirth), gender identity, expression or dysphoria, marital status, age, national origin or ancestry, physical or mental disability, medical condition, genetic information, veteran status, caregiver status, sexual orientation, transgender status or any other classification protected by federal, state or local laws or because of the individual’s association with a member of a protected group or connection to an organization or group related to a protected group.We comply with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Atara Bio in the United States. Jun 2nd, 2019 11:12PM Jun 2nd, 2019 11:12PM Health Care Pharmaceuticals & Biotechnology
nasdaq:atra www.atarabio.com www.atarabio.com Jun 3rd, 2019 12:00AM Research Associate/Senior Research Associate – CAR-T Development Open Pre-Clinical and Translational Science Thousand Oaks, CA, United States Thousand Oaks CA USA May 23rd, 2019 12:00AM We launched Atara Biotherapeutics in August 2012 to help patients with serious diseases and few therapeutic options. We’re named after Atara Ciechanover who suffered from cancer before passing away. We are considered a leading off-the-shelf T-cell immunotherapy company (Nasdaq ATRA) developing novel treatments for patients with cancer, autoimmune and viral diseases.Position SummaryThe Research Associate/Senior Research Associate – CAR-T Development serves as a technical expert in the generation and characterization of novel CTL and Chimeric Antigen Receptor (CAR) T cell therapies within the Preclinical and Translational Sciences group. The successful candidate independently performs experiments to support new product development and IND-enabling activities for Atara’s early engineered T cell pipeline. Reports to                Principal Scientist – CAR-T DevelopmentLocation                   Thousand Oaks (northwest Los Angeles area), CAPosition ResponsibilitiesPerforms retroviral (gamma retrovirus and/or lentiviral) transductions of primary T cells and propagation.Evaluates allogeneic CAR T cell activity, efficacy, and alloreactivity.Performs primary immune cell isolation and multi-parameter immunophenotyping by flow cytometry.Designs and executes assays to evaluate target-specific T cell characteristics and function.Performs mammalian cell culture and production of recombinant transient and stable mammalian cell lines.Contributes to experimental design and project direction.Facilitates the establishment of a molecular and cellular lab infrastructure and routine operations.Maintains detailed documentation of laboratory procedures and experiments.Prepares data presentations for internal group meetings.Role model for Atara’s Values of patients first, innovation teamwork, community and mindset.Travel   Travel may be required (up to 10%).Physical Requirements:Subject to extended periods of sitting and/or standing, vision to monitor and moderate noise levels. Work is generally performed in an office, laboratory, or manufacturing environment. Position RequirementsBS degree with 2+ year’s experience or MS with 3+ year’s experience in cell biology, immunology, molecular biology or related discipline.Ability to generate and characterize genetically modified primary T lymphocytes using standard immunological assays including flow cytometry.Expertise with retroviral/lentiviral transduction and primary cell transformation.Expertise in Immune cell-based assays including proliferation and cytotoxicity.Experience in gene editing technologies including CRISPR/Cas9.Expertise inculturing PBMCs, human lymphocytes, and mammalian cell lines.Experience with propagation of gene modified T cell cultures.Excellent record keeping and communication skillsand computer skills including experience with FlowJo, Microsoft Excel, PowerPoint, and Graphpad Prism.More About Atara BiotherapeuticsNow in our sixth year, we’re proud of our team of 300+ Atarians co-located by design in South San Francisco (corporate headquarters) and Southern California (R&D and manufacturing headquarters in the northwest Los Angeles area) with a newly-established European headquarters in Zug, Switzerland. Atara also has a R&D site in the Denver, Colorado area and an office in New York City. Our Southern California hub is anchored by a new 90,000 sq. ft., state-of-the-art Atara T-Cell Operations and Manufacturing (ATOM) facility in Thousand Oaks, California.One mission – “Transform the lives of patients with serious medical conditions through pioneering science, teamwork and expertise” – and a singular vision – “Cell therapy treatment for every patient, any time – provide inspiration and direction for all of us.”The Company's off-the-shelf, allogeneic T-cells are bioengineered from donors with healthy immune function and allow for rapid delivery from inventory to patients without a requirement for pretreatment. Atara's T-cell immunotherapies are designed to precisely recognize and eliminate cancerous or diseased cells without affecting normal, healthy cells.Atara's most advanced T-cell immunotherapy in development, tabelecleucel, or tab-cel™ (formerly known as ATA129), is being developed for the treatment of patients with Epstein-Barr virus (EBV) associated post-transplant lymphoproliferative disorder (EBV+ PTLD) who have failed rituximab, as well as other EBV-associated hematologic and solid tumors, including nasopharyngeal carcinoma (NPC). Tab-cel™ is in Phase 3 clinical development for the treatment of EBV+ PTLD following an allogeneic hematopoietic cell transplant (MATCH study) or solid organ transplant (ALLELE study).Atara is also developing off-the-shelf, allogeneic ATA188 and autologous ATA190 T-cell immunotherapies using a complementary targeted antigen recognition technology for specific EBV antigens believed to be important for the potential treatment of multiple sclerosis (MS). A Phase 1 clinical study of autologous ATA190 in patients with progressive MS is ongoing. Atara is also advancing a Phase 1 clinical study of ATA188 in patients with progressive or relapsing-remitting MS across clinical sites in the United States and Australia. Atara's clinical pipeline also includes ATA520 targeting Wilms Tumor 1 (WT1) and ATA230 directed against cytomegalovirus (CMV). Working at AtaraPeople at Atara are high integrity, roll-up-your-sleeves, get-it-done types who are keenly committed to putting patients first, advancing medical care and doing so with demonstrated urgency. At their core Atarians are people who work well with others and are “team-centric”, have purposeful curiosity and can’t wait to save patient lives. And similar to other biotech companies who have so many accomplished people, we expect humility (we are a “low hubris” sort of place), flexibility, respect, teamwork, good judgment and getting the most out of any dollar we spend. We also expect to enjoy the journey (and each other) as we move forward with a shared responsibility to teach and to learn from what we do and from our teammates. Atara is an equal opportunity employer and makes employment decisions on the basis of merit and other lawful factors. In accordance with applicable law, the Company prohibits discrimination based on race, color, religion, creed, sex, gender (including pregnancy, childbirth or medical condition related to pregnancy or childbirth), gender identity, expression or dysphoria, marital status, age, national origin or ancestry, physical or mental disability, medical condition, genetic information, veteran status, caregiver status, sexual orientation, transgender status or any other classification protected by federal, state or local laws or because of the individual’s association with a member of a protected group or connection to an organization or group related to a protected group.We comply with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Atara Bio in the United States. Jun 2nd, 2019 11:12PM Jun 2nd, 2019 11:12PM Health Care Pharmaceuticals & Biotechnology
nasdaq:atra www.atarabio.com www.atarabio.com Jun 3rd, 2019 12:00AM Senior Manager/Associate Director, Regulatory Affairs Open Regulatory Affairs Thousand Oaks, CA, United States Thousand Oaks CA USA May 23rd, 2019 12:00AM We launched Atara Biotherapeutics in August 2012 to help patients with serious diseases and few therapeutic options. We’re named after Atara Ciechanover who suffered from cancer before passing away. We are considered a leading off-the-shelf T-cell immunotherapy company (Nasdaq ATRA) developing novel treatments for patients with cancer, autoimmune and viral diseases.Position:                         Senior Manager / Associate Director, Regulatory AffairsPosition SummaryThis position supports all regulatory affairs activities for the company’s products, including but not limited to collecting and summarizing regulatory intelligence, performing regulatory assessments, participation in project teams, providing input for regulatory submissions, and managing the compilation and review of all submissions for completeness and quality.Reports to:                      Senior Director in Regulatory AffairsLocation:                         Thousand Oaks, CAPrimary ResponsibilitiesManage regulatory projects and closely collaborate with Clinical, Regulatory Operations, other scientific and technical departments and external vendors to coordinate and implement submission strategy and content in a global clinical bio-pharmaceutical development environment.Provide updates on strategic regulatory intelligence, such as new regulations, guidance, ODACs, competitive product applications and approvals, etc.Provide regulatory intelligence to inform regulatory strategies, including scenarios for the earliest regulatory approvals possible as well as an assessment of risk for each of the various scenarios.Provide tactical support for the timely preparation, editing and review of submissions, including regulatory agency Meeting Requests and Briefing Documents, IND/CTA amendments, original BLAs and international Marketing Authorization Applications and their respective amendments/supplements.Coordinate and manage regulatory submission documents (e.g., cover letters, Meeting Requests, Meeting Briefing Packages, etc.) to produce submission ready content. Coordinate interdepartmental team review and approval of submission document deliverables including: distribute drafts, attend/steer review meetings, and incorporate revisions.Manage the quality, accuracy, compliance with internal and external standards, and the timely production of submission documents using manual and electronic document management systems such as Veeva, as appropriate.Work with Regulatory Operations or publishing vendors to compile and review regulatory submissions for completeness and quality, ensuring that Atara’s practices are in conformance with the latest health authority and industry submission standards.Assist with logging, tracking and filing of correspondence with regulatory authorities and ensuring that no commitment remains unduly outstanding.CMC regulatory expertise is a plusSkills and AbilitiesTakes ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance, as necessary.Understands and interprets data/information and its practical application Strong communication skills (e.g., clear and concise), team player, and proven negotiation skills.Strong understanding of pharmaceutical biologics drug development, clinical research, study design, biostatistics, pharmacokinetics, the regulatory environment, project management, and medical terminology.Working knowledge of manufacturing research and development. CMC regulatory experience, and/or knowledge of cellular therapies manufacturing, and quality development would be an advantage.Strong time and project management skills.Strong critical and logical thinking with ability to analyze problems, identify alternative solutions, and implement recommendations for resolution.Self-motivated, flexible and creative leader, able to prioritize, multi-task, and work in a fast-paced & demanding environment.Education and Professional ExperienceBachelor’s degree (MS preferred), in Life Sciences/Health Related field, from an accredited college or university with 10 or more years drug development or related experience with 5+ years in Regulatory Affairs.Extensive knowledge of regulatory requirements.Proficient in pertinent software & tools.Must be knowledgeable in industry trends for study reports and dossier preparation (e.g., IND/CTA/NDA/NDS), including electronic document submissions (i.e., eCTD).Physical Requirements:Subject to extended periods of sitting and standing, vision to monitor and moderate noise levels. Work is performed in an office environment. Travel:                                 Travel may be required (up to 10%).More About Atara Bio:Now in our sixth year, we’re proud of our team of 300+ Atarians co-located by design in South San Francisco (corporate headquarters) and Southern California (R&D and manufacturing headquarters in the northwest Los Angeles area) with a newly-established European headquarters in Zug, Switzerland. Atara also has a R&D site in the Denver, Colorado area and an office in New York City. Our Southern California hub is anchored by a new 90,000 sq. ft., state-of-the-art Atara T-Cell Operations and Manufacturing (ATOM) facility in Thousand Oaks, California.One mission – “Transform the lives of patients with serious medical conditions through pioneering science, teamwork and expertise” – and a singular vision – “Cell therapy treatment for every patient, any time – provide inspiration and direction for all of us.”The Company's off-the-shelf, allogeneic T-cells are bioengineered from donors with healthy immune function and allow for rapid delivery from inventory to patients without a requirement for pretreatment. Atara's T-cell immunotherapies are designed to precisely recognize and eliminate cancerous or diseased cells without affecting normal, healthy cells.Atara's most advanced T-cell immunotherapy in development, tabelecleucel, or tab-cel™ (formerly known as ATA129), is being developed for the treatment of patients with Epstein-Barr virus (EBV) associated post-transplant lymphoproliferative disorder (EBV+ PTLD) who have failed rituximab, as well as other EBV-associated hematologic and solid tumors, including nasopharyngeal carcinoma (NPC). Tab-cel™ is in Phase 3 clinical development for the treatment of EBV+ PTLD following an allogeneic hematopoietic cell transplant (MATCH study) or solid organ transplant (ALLELE study).Atara is also developing off-the-shelf, allogeneic ATA188 and autologous ATA190 T-cell immunotherapies using a complementary targeted antigen recognition technology for specific EBV antigens believed to be important for the potential treatment of multiple sclerosis (MS). A Phase 1 clinical study of autologous ATA190 in patients with progressive MS is ongoing. Atara is also advancing a Phase 1 clinical study of ATA188 in patients with progressive or relapsing-remitting MS across clinical sites in the United States and Australia. Atara's clinical pipeline also includes ATA520 targeting Wilms Tumor 1 (WT1) and ATA230 directed against cytomegalovirus (CMV).Working at Atara Bio:People at Atara Bio are high integrity, roll-up-your-sleeves, get-it-done types who are keenly committed to putting patients first, advancing medical care and doing so with demonstrated urgency. At their core Atarians are people who work well with others and are “team-centric”, have purposeful curiosity and can’t wait to save patient lives. And similar to other biotech companies who have so many accomplished people, we expect humility (we are a “low hubris” sort of place), flexibility, respect, teamwork, good judgment and getting the most out of any dollar we spend. We also expect to enjoy the journey (and each other) as we move forward with a shared responsibility to teach and to learn from what we do and from our teammates.Atara Bio is an equal opportunity employer and makes employment decisions on the basis of merit and other lawful factors. In accordance with applicable law, the Company prohibits discrimination based on race, color, religion, creed, sex, gender (including pregnancy, childbirth or medical condition related to pregnancy or childbirth), gender identity, expression or dysphoria, marital status, age, national origin or ancestry, physical or mental disability, medical condition, genetic information, veteran status, caregiver status, sexual orientation, transgender status or any other classification protected by federal, state or local laws or because of the individual’s association with a member of a protected group or connection to an organization or group related to a protected group.We comply with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Atara Bio in the United States. Jun 2nd, 2019 11:12PM Jun 2nd, 2019 11:12PM Health Care Pharmaceuticals & Biotechnology
nasdaq:atra www.atarabio.com www.atarabio.com Jun 3rd, 2019 12:00AM Director Next Generation CAR-T (off-the-shelf), Clinical R&D Open Research & Development Thousand Oaks, CA, United States Thousand Oaks CA USA May 23rd, 2019 12:00AM Position Summary:    We are looking for a board-certified medical oncologist/hematologist/infectious disease/rheumatologist with immunotherapy experience to provide medical and scientific leadership to our engineered T cell programs. Atara is building engineered CAR T cells that target Acute Myelogenous Leukemia, B cell malignancies, solid tumors, infectious disease and autoimmune disease, taking advantage of our experience with off-the-shelf viral T cells to revolutionize access and speed to treatment for patients. Novel CAR signaling domains derived from scientific collaborations will be integrated from pre-eminent academic institutions that promise to improve T cell persistence and potency.  In addition, our solid tumor targeting CARs incorporate checkpoint inhibition to overcome the immunosuppressive tumor cell microenvironment.   The Director will be responsible for designing and monitoring clinical trials to evaluate the efficacy, safety, kinetics of T cell expansion, and biomarker program for CAR T product candidates working together with internal and external regulatory colleagues.  He/she will manage clinical and scientific collaborations with academic pioneers and consultants, will participate in regulatory interactions to support IND submission and clinical development in a fast-paced environment, and will gain experience in business development and product assessment. The Director must have an excellent immunotherapy scientific knowledge base to operationalize the CAR T programs. Reports to:   EVP, Chief Scientific OfficerLocation:      Westlake Village, CA.Primary ResponsibilitiesContributes to design of immuno-oncology CAR T clinical trials, including literature review, development of clinical protocols and amendments, investigator brochures, annual reports, abstracts, manuscripts and clinical study reports in collaboration with the cross functional team and academic collaborators.Serves as a medical monitor, including evaluation of the safety, pharmacology and efficacy in ongoing and completed studies and advocates for the health and well-being of patients.As the medical lead of a study, responsible for ensuring data quality, summary and writing of clinical study reports in close collaboration with the clinical operations, biometrics and medical writing team.Works on IND, EOP2, BTD, BLA and equivalent international submission documents.Establishes and implements exploratory pharmacodynamic, predictive and prognostic biomarker plans in conjunction with staff, consultants and collaborators.Ensures adherence to Atara Bio’s Standard Operating Procedures. Travel- Travel is required (up to 25%).Physical Requirements Subject to extended periods of sitting and/or standing, vision to monitor and moderate noise levels. Work is generally performed in an office or clinical environment. Car and airplane (see above) travel is an essential part of the job. Professional QualificationsMinimum of an M.D. or M.D./Ph.D., and advanced training in hematology, oncology, infectious disease or rheumatology with immunology or similar experience preferred. Board certification is preferred.Experience designing, leading and managing clinical studies in solid tumors, hematologic malignancies and preferably immuno-oncology preferred.Knowledge of Good Clinical Practices, FDA regulations and guidelines and applicable regulatory requirements.Ability to explain immunologic and oncologic technical issues to clinical, regulatory, biomarker, biostatistics, data management and manufacturing colleagues who may have a non-medical background.Ability to work independently.Experience working effectively in a fast-paced, team-based environment.Strong clinical/scientific/technical skills.Ability to anticipate and resolve problems effectively.Strong verbal communication and technical writing skills.Ability to present clearly using scientific and clinical terminology.Strong interpersonal skills and the ability to communicate effectively with people in diverse and different settings.Sound organizational skills.Possesses sense of urgency; identifies challenges and problems and takes the initiative to identify solutions.Motivates team members; fosters and nurtures teamwork.Project management skills and focus on delivery of results.Role model for Atara’s values of patients first, innovation, teamwork, community and mindset. Jun 2nd, 2019 11:12PM Jun 2nd, 2019 11:12PM Health Care Pharmaceuticals & Biotechnology
nasdaq:atra www.atarabio.com www.atarabio.com Jun 3rd, 2019 12:00AM Director, Compliance Counsel Open Legal South San Francisco, CA, United States South San Francisco CA USA May 28th, 2019 12:00AM We launched Atara Biotherapeutics in August 2012 to help patients with serious diseases and few therapeutic options. We’re named after Atara Ciechanover who suffered from cancer before passing away. We are considered a leading off-the-shelf T-cell immunotherapy company (Nasdaq ATRA) developing novel treatments for patients with cancer, autoimmune and viral diseases.Job Summary & Responsibilities Atara is currently seeking a Director, Compliance Counsel. This individual is responsible for working with the Head of Global Compliance to implement and manage Atara’s Corporate Compliance and Ethics Program both domestically and internationally and is responsible for the promotion of an on-going culture of compliance and prevention of illegal and unethical conduct. He/she will have excellent communication skills and act as a change agent to engender a culture of compliance within the company. This position will report to Atara’s Head of Global Compliance.Work collaboratively with Legal team partners on all topics relating to healthcare compliance.Assist the Head of Global Compliance with the implementation and interpretation of healthcare compliance policies. Periodically review/update written policies and procedures, including the company’s Code of Conduct.Provide counseling on appropriate relationships with healthcare professionals, patients, managed care entities, academic institutions, and government entities.Advise on aspects of the Food, Drug and Cosmetic Act (FDCA), Federal and State Anti-Kickback Statutes, False Claims Act, HHS OIG fraud and abuse regulations and opinions, and HIPAA laws and regulations.Partner with functional teams to establish a rapport and positive working relationship with respect to compliance initiatives at Atara.Work collaboratively and creatively with stakeholders to provide compliance support and day-to-day counseling. Clearly and effectively render practical, timely advice while serving as a member of various cross-functional teams to support the successful product launch and associated activities.Provide legal advice, education, training and direction on activities that implicate FDA promotional laws and regulations, Sunshine Act/Transparency laws, scientific publications and data disclosure and related laws, regulations and industry standards (e.g., PhRMA Code, ICJME and GPP standards, ACCME guidelines).Review and provide guidance on disease education/disease awareness campaigns and promotional marketing materials, speaker programs, grants and sponsorships, Investigator Sponsored Studies, market planning activities, sales incentives and direction, commercial learning, medical communications, Medical Science Liaisons, patient education materials, reprint distribution, and publication plans.Provide guidance to Commercial and Medical Affairs functions (including senior managers) on the appropriate interactions of Sales, Market Access, and Medical Affairs field-based employees.Maintain an effective compliance communication program for the organization, including promoting the use of the compliance hotline; (b) heightened awareness of Code of Conduct, and (c) understanding of new and existing compliance issues and related policies and procedures.Respond to alleged violations of rules, regulations, policies, procedures and Code of Conduct by recommending the initiation of investigative procedure; collaborate with other departments to direct compliance issues to appropriate channels for investigation and resolution.Assist with the roll out of effective training programs. Role RequirementsJD degree plus at least 6 years of relevant experience required2+ years of Biopharma experience (either in-house or as external counsel)Travel:                        Travel required (up to 25%)Physical Requirements: Subject to extended periods of sitting and/or standing, vision to monitor and moderate noise levels. Work is generally performed in an office or clinical environment. Car and airplane (see travel above) travel is an essential part of the job.Skills And KnowledgeExperience in the development, initiation, maintenance and revision of policies and procedures for the general operation of a compliance program and its related activities to prevent illegal, unethical or improper conduct.Experience in and knowledge of industry standards and regulations for and risks facing a global pharmaceutical or biotech company, including anti-bribery, anti-corruption, 3rd party distributors, anti-kickback, off-label promotion, etc.In-depth knowledge and understanding of compliance risk management practices and methodologies, including risk assessment, monitoring/surveillance and testing activitiesExperience with data privacy regulations (HIPAA, GDPR) preferred.Multi-geographic experience preferred.Strong project management skills, including managing and prioritizing multiple concurrent projects, managing budgets and resources and reporting progress and risks to colleagues and senior management.Experience in developing and maintaining effective lines of communication, including the management of a compliance hotline.Extremely detail oriented with strong analytical, written and verbal communication skills.More About Atara Bio: Now in our sixth year, we’re proud of our team of 300+ Atarians co-located by design in South San Francisco (corporate headquarters) and Southern California (R&D and manufacturing headquarters in the northwest Los Angeles area) with a newly-established European headquarters in Zug, Switzerland. Atara also has a R&D site in the Denver, Colorado area and an office in New York City. Our Southern California hub is anchored by a new 90,000 sq. ft., state-of-the-art Atara T-Cell Operations and Manufacturing (ATOM) facility in Thousand Oaks, California.One mission – “Transform the lives of patients with serious medical conditions through pioneering science, teamwork and expertise” – and a singular vision – “Cell therapy treatment for every patient, any time – provide inspiration and direction for all of us.”The Company's off-the-shelf, allogeneic T-cells are bioengineered from donors with healthy immune function and allow for rapid delivery from inventory to patients without a requirement for pretreatment. Atara's T-cell immunotherapies are designed to precisely recognize and eliminate cancerous or diseased cells without affecting normal, healthy cells.Atara's most advanced T-cell immunotherapy in development, tabelecleucel, or tab-cel™ (formerly known as ATA129), is being developed for the treatment of patients with Epstein-Barr virus (EBV) associated post-transplant lymphoproliferative disorder (EBV+ PTLD) who have failed rituximab, as well as other EBV-associated hematologic and solid tumors, including nasopharyngeal carcinoma (NPC). Tab-cel™ is in Phase 3 clinical development for the treatment of EBV+ PTLD following an allogeneic hematopoietic cell transplant (MATCH study) or solid organ transplant (ALLELE study).Atara is also developing off-the-shelf, allogeneic ATA188 and autologous ATA190 T-cell immunotherapies using a complementary targeted antigen recognition technology for specific EBV antigens believed to be important for the potential treatment of multiple sclerosis (MS). A Phase 1 clinical study of autologous ATA190 in patients with progressive MS is ongoing. Atara is also advancing a Phase 1 clinical study of ATA188 in patients with progressive or relapsing-remitting MS across clinical sites in the United States and Australia. Atara's clinical pipeline also includes ATA520 targeting Wilms Tumor 1 (WT1) and ATA230 directed against cytomegalovirus (CMV).Working at Atara Bio: People at Atara Bio are high integrity, roll-up-your-sleeves, get-it-done types who are keenly committed to putting patients first, advancing medical care and doing so with demonstrated urgency. At their core Atarians are people who work well with others and are “team-centric”, have purposeful curiosity and can’t wait to save patient lives. And similar to other biotech companies who have so many accomplished people, we expect humility (we are a “low hubris” sort of place), flexibility, respect, teamwork, good judgment and getting the most out of any dollar we spend. We also expect to enjoy the journey (and each other) as we move forward with a shared responsibility to teach and to learn from what we do and from our teammates.Atara Bio is an equal opportunity employer and makes employment decisions on the basis of merit and other lawful factors. In accordance with applicable law, the Company prohibits discrimination based on race, color, religion, creed, sex, gender (including pregnancy, childbirth or medical condition related to pregnancy or childbirth), gender identity, expression or dysphoria, marital status, age, national origin or ancestry, physical or mental disability, medical condition, genetic information, veteran status, caregiver status, sexual orientation, transgender status or any other classification protected by federal, state or local laws or because of the individual’s association with a member of a protected group or connection to an organization or group related to a protected group.We comply with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Atara Bio in the United States. Jun 2nd, 2019 11:12PM Jun 2nd, 2019 11:12PM Health Care Pharmaceuticals & Biotechnology

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