EP

Epizyme

- NASDAQ:EPZM
Last Updated 2019-11-14

Job Listings

Track Epizyme hiring and firing trends, filtered by title, location, type, date, category and date of posting.
Ticker Symbol Entity Name Domain As Of Date Title URL Brand Category Location Text City State Country Posted Date Number of Openings Description Date Added Date Updated GICS Sector GICS Industry
nasdaq:epzm www.epizyme.com www.epizyme.com Nov 13th, 2019 12:00AM Director, CMC Regulatory Open Regulatory Affairs Sep 18th, 2019 12:00AM Epizyme, Inc. is a late-stage biopharmaceutical company committed to rewriting treatment for cancer and other serious diseases through novel epigenetic medicines.  Epizyme is broadly developing its lead product candidate, tazemetostat, a first-in-class EZH2 inhibitor, with studies underway in both solid tumors and hematological malignancies, as a monotherapy and combination therapy in relapsed and front-line disease. The company is also developing a novel G9a program with its next development candidate, EZM8266, which is targeting sickle cell disease.  By focusing on the genetic drivers of disease, Epizyme's science seeks to match targeted medicines with the patients who need them.  Epizyme has assembled a world-class team with a passion for scientific innovation and a commitment to developing novel epigenetic therapies.  Join a dynamic, diverse and fun work environment consistent with Epizyme’s cultural attributes for success: camaraderie, collaboration, disciplined, innovative, openness, patient-focused and resilient.  Reporting to the Chief Regulatory Officer, the Director, CMC Regulatory will work closely with Pharmaceutical Sciences, GMP Quality Assurance, and cross-functional project teams, to develop and operationalize CMC regulatory strategies in support of Epizyme’s business objectives. Responsibilities Provide strategic CMC regulatory leadership in support of Epizyme’s portfolio of early- and late-stage development programs, as well as future marketed products.Interact effectively with cross-functional stakeholders, including colleagues in Regulatory, Pharmaceutical Sciences, and GMP QA, as well as external development and manufacturing partners.Lead and manage the timely preparation of high-quality CMC documents and submissions, including INDs/CTAs/IMPDs, NDAs/MAAs, amendments, supplements, responses to information requests, and briefing documents for regulatory agency interactions.Ensure that CMC submissions are complete and meet applicable regulatory requirements.Work with Pharmaceutical Sciences, to prepare for and conduct CMC-related meetings with regulatory agencies.Lead CMC regulatory intelligence activities, monitoring guidelines and trends, interpreting CMC regulations and guidance documents, and providing regulatory advice to in-house CMC and project teams.Work with Pharmaceutical Sciences and GMP to assess proposed manufacturing changes, providing strategic regulatory guidance and define reporting requirements.Conduct risk assessments and develop mitigation strategies for CMC regulatory matters.Support on-site regulatory inspections as a Subject Matter Expert (SME).Provide input on SOP development.Education & RequirementsBachelor’s degree in a scientific or engineering discipline; advanced degree (MS or Ph.D.) preferred.10+ years of relevant industry experience, with a combination of experience in small molecule CMC development, manufacturing, and/or CMC regulatory with 5+ years in a Regulatory CMC role.Successful track record in CMC submissions to regulatory agencies and meetings.Strong knowledge of current Good Manufacturing Practices (cGMPs), as well as drug development guidelines and regulations (ICH, FDA, and EMA).Ability to lead, motivate, and engage others to ensure successful delivery of projects.Strong interpersonal, project management, and organizational skills with experience in issue resolution and closure.Superb technical-regulatory writing and oral communication skills, with the ability to shape, frame, and present to diverse audiences. Experience in interacting with regulatory authorities required.Ability to analyze complex issues and to develop proactive recommendations that translate strategy into action.Proficiency in Microsoft Office, Adobe Acrobat, SharePoint, and electronic publishing.Occasional travel may be required (approximately 5 % of time).Clear alignment with Epizyme’s Core Values: Collaboration, Disciplined, Innovative, Openness, Patient-Focused, and Resilient.Epizyme, Inc. is a vibrant, entrepreneurial EEO employer committed to a diverse and dynamic workplace. Nov 13th, 2019 02:38AM Nov 13th, 2019 02:38AM Health Care Pharmaceuticals & Biotechnology
nasdaq:epzm www.epizyme.com www.epizyme.com Nov 13th, 2019 12:00AM Assistant General Counsel - Business Development Open Legal Sep 24th, 2019 12:00AM Epizyme, Inc. is a late-stage biopharmaceutical company committed to rewriting treatment for cancer and other serious diseases through novel epigenetic medicines.  Epizyme is broadly developing its lead product candidate, tazemetostat, a first-in-class EZH2 inhibitor, with studies underway in both solid tumors and hematological malignancies, as a monotherapy and combination therapy in relapsed and front-line disease. The company is also developing a novel G9a program with its next development candidate, EZM8266, which is targeting sickle cell disease.  By focusing on the genetic drivers of disease, Epizyme's science seeks to match targeted medicines with the patients who need them. Epizyme has assembled a world-class team with a passion for scientific innovation and a commitment to developing novel epigenetic therapies.  Join a dynamic, diverse and fun work environment consistent with Epizyme’s cultural attributes for success: camaraderie, collaboration, disciplined, innovative, openness, patient-focused and resilient. The legal team is seeking an experienced attorney with 10+ years of relevant pharmaceutical industry experience with a focus on corporate law, licensing and collaborations. This position reports directly to the Epizyme General Counsel, and is based in Cambridge, MA. Key Responsibilities: Serve as strategic business partner to the business development teamLead negotiator and drafter in collaboration and licensing dealsLead counsel managing key alliances, SEC reporting and corporate governanceEnsure that clients are kept abreast of all relevant legal developments in their areas of businessCoordinate the legal aspects of client projectsContribute to the achievement of clients’ business objectivesAct as Legal Department representative on cross-functional teams, as assignedCoordinate with and support other members of the Epizyme Legal Team Education & Requirements:Candidates for the position should have the following: JD required, 10 or more years of experience working in private practice and/or in-house within the pharmaceutical industry, experience with counseling business leaders, and a strong understanding of the business and legal challenges that impact the pharmaceutical industry. The successful candidate will possess the following attributes:Substantive experience in executing business development in a life science companyExperience working with pharmaceutical, biotechnology, or medical device with M&A structuring and deal executionKnowledge of FDA promotional, advertising, and labeling requirements and processes for drugsExcellent academic credentials, including a J.D. from a highly respected, accredited law schoolGood standing of at least one state barPrior experience as a member of an in-house legal department at a biotechnology or pharmaceuticals company preferredExperience working in a matrix environmentStrong verbal and written communication skillsAbility to provide and effectively communicate sound legal advice coupled with a strong understanding of business needsEpizyme, Inc. is a vibrant, entrepreneurial EEO employer committed to a diverse and dynamic workplace. Nov 13th, 2019 02:38AM Nov 13th, 2019 02:38AM Health Care Pharmaceuticals & Biotechnology
nasdaq:epzm www.epizyme.com www.epizyme.com Nov 13th, 2019 12:00AM Senior Clinical Research Scientist (Oncology) Open Clinical Research Oct 1st, 2019 12:00AM Epizyme, Inc. is a late-stage biopharmaceutical company committed to rewriting treatment for cancer and other serious diseases through novel epigenetic medicines.  Epizyme is broadly developing its lead product candidate, tazemetostat, a first-in-class EZH2 inhibitor, with studies underway in both solid tumors and hematological malignancies, as a monotherapy and combination therapy in relapsed and front-line disease. The company is also developing a novel G9a program with its next development candidate, EZM8266, which is targeting sickle cell disease.  By focusing on the genetic drivers of disease, Epizyme's science seeks to match targeted medicines with the patients who need them.  Epizyme has assembled a world-class team with a passion for scientific innovation and a commitment to developing novel epigenetic therapies.  Join a dynamic, diverse and fun work environment consistent with Epizyme’s cultural attributes for success: camaraderie, collaboration, disciplined, innovative, openness, patient-focused and resilient.  This position is responsible for working with the physicians and cross functional colleagues within Clinical Development to provide clinical research support for programs as assigned.  Responsibilities Develops protocols and informed consent documents for clinical studiesAnalyzes clinical data and presents findings to clinical teamDrafts clinical scientific documents such as IND, IND amendments, Investigator Brochures, and other documents for FDA/EMA submissionsContributes actively in the CSR preparation and finalizationMonitors, & reviews along with the medical monitor safety and efficacy data in ongoing studies; monitors GCP compliance with help of clinical operations and CROContributes to the development of CRFsAnswers along with the medical monitor patient eligibility questions from CRO and siteMay have a leadership role in the matrix teams for assigned compoundsDevelops and maintains relationships with appropriate KOLs, investigators, cooperative groups, and patient advocacies. Serves as first point of contact for medical questions from sitesAssists and/or writes with clinical abstracts, assists and/or presents data at scientific meetings, SIVs; conducts protocol trainingParticipates with clinical operations in the CRO/vendor selection and biddingKeeps abreast of oncology treatment modalities, drug mechanism of action, approaches to drug development and regulatory requirementsActs as the clinical representative in variety of cross-functional teams Education & Requirements Advanced degree in scientific/life-sciences/clinical/nursing field. M.Sc., Ph.D. preferredMinimum of 5 years of clinical drug development experiencePrior drug development experience in oncology is requiredAbility to multi-task well, to deal well with conflict and obstacles, and to work in a fast-paced environmentExcellent written and oral communication skillsStrong analytical ability  Epizyme, Inc. is a vibrant, entrepreneurial EEO employer committed to a diverse and dynamic workplace. Nov 13th, 2019 02:38AM Nov 13th, 2019 02:38AM Health Care Pharmaceuticals & Biotechnology
nasdaq:epzm www.epizyme.com www.epizyme.com Nov 13th, 2019 12:00AM Associate Director, Compliance Open Legal Oct 1st, 2019 12:00AM Epizyme, Inc. is a late-stage biopharmaceutical company committed to rewriting treatment for cancer and other serious diseases through novel epigenetic medicines.  Epizyme is broadly developing its lead product candidate, tazemetostat, a first-in-class EZH2 inhibitor, with studies underway in both solid tumors and hematological malignancies, as a monotherapy and combination therapy in relapsed and front-line disease. The company is also developing a novel G9a program with its next development candidate, EZM8266, which is targeting sickle cell disease.  By focusing on the genetic drivers of disease, Epizyme's science seeks to match targeted medicines with the patients who need them. Epizyme has assembled a world-class team with a passion for scientific innovation and a commitment to developing novel epigenetic therapies.  Join a dynamic, diverse and fun work environment consistent with Epizyme’s cultural attributes for success: camaraderie, collaboration, disciplined, innovative, openness, patient-focused and resilient. Reporting to the Chief Compliance Officer, the Associate Director will support the design, implementation, and enhancement of Epizyme’s compliance program and its compliance operations. The Associate Director will work closely with business colleagues on the Commercial, Medical Affairs, Finance, Human Resources, and Legal teams to sustain Epizyme’s strong ethical culture and ensure adherence to the Company’s Code of Conduct and related rules, policies, and procedures. The Associate Director will also focus on effective compliance operations with a specific focus on areas including transparency reporting, managing engagements with heath care providers, and training.We are seeking an experienced compliance professional with 7+ years of relevant pharmaceutical industry experience. This position reports directly to the Chief Compliance Officer, and is based in Cambridge, MA.Key Responsibilities: Partner with employees and leadership to maintain and further develop throughout the organization a strong culture of ethics and compliance, including personal accountability at all levels in the organization with a spirit of partnership and positive problem solvingEnsure client operations comply with applicable laws and company policies, including Anti-kickback Statute and other US healthcare compliance laws and regulations, antitrust, and FDA requirements;Support the implementation and maintenance of US federal and state transparency reporting requirements and assist business leadership in meeting reporting obligationsEnsure that interactions with health care professionals and patients comply with applicable legal requirements and company policiesAnalyze advisory board proposals, speaker programs, and medical education initiatives for fraud and abuse, FDA, and other regulatory complianceSupport the implementation of a robust privacy program and help pull through privacy requirementsPrepare and deliver training and education to ensure understanding of employee responsibilities and ethics and compliance issues, as well as related policies and proceduresExecute routine and risk based monitoring and auditing of relevant business activities and related policies and procedures; identify potential areas of compliance vulnerability and risk; assist in and oversee the implementation of corrective action plans as necessary; and generate reports on monitoring, auditing and risk assessmentTravel requiredOther responsibilities as may be assigned from time to time in the company’s discretionEducation & Requirements:Candidates for the position should have the following: JD preferred, 5-7 years of experience working within the pharmaceutical industry, experience with counseling business leaders, and a strong understanding of the operational requirements for a compliance program in the pharmaceutical industry.The successful candidate will possess the following attributes:Minimum of 5-7 years of ethics, compliance and/or legal experience in a Commercial stage organization subject to US biopharmaceutical, medical device or other relevant healthcare compliance laws and regulationsExperience in biotech, healthcare or medical device industries is preferredExperience developing, implementing, and monitoring a compliance programExperience with metrics used to measure success of the compliance programDemonstrated experience identifying and resolving compliance issuesDemonstrated ability to work collaboratively and cross-functionally in a team environment with a wide variety of company personnel on a broad range of mattersAbility to manage multiple tasks simultaneously and to flourish in a fast-paced and high energy environmentAble and eager to work independently and to manage and oversee discrete areas of responsibility with little direct supervisionExcellent organization, communication and prioritization skills, including the ability to communicate concisely, to integrate legal and business considerations, and to provide balanced advice regarding risksExperience with transparency reporting and privacy a plusEpizyme, Inc. is a vibrant, entrepreneurial EEO employer committed to a diverse and dynamic workplace. Nov 13th, 2019 02:38AM Nov 13th, 2019 02:38AM Health Care Pharmaceuticals & Biotechnology
nasdaq:epzm www.epizyme.com www.epizyme.com Nov 13th, 2019 12:00AM Associate Director/Director Labeling and Promotional/Advertisement Regulatory Affairs Open Regulatory Affairs Oct 11th, 2019 12:00AM Epizyme, Inc. is a late-stage biopharmaceutical company committed to rewriting treatment for cancer and other serious diseases through novel epigenetic medicines.  Epizyme is broadly developing its lead product candidate, tazemetostat, a first-in-class EZH2 inhibitor, with studies underway in both solid tumors and hematological malignancies, as a monotherapy and combination therapy in relapsed and front-line disease. The company is also developing a novel G9a compound targeting sickle cell disease.  By focusing on the genetic drivers of disease, Epizyme's science seeks to match targeted medicines with the patients who need them.  Epizyme has assembled a world-class team with a passion for scientific innovation and a commitment to developing novel epigenetic therapies.  Join a dynamic, diverse and fun work environment consistent with Epizyme’s cultural attributes for success: camaraderie, collaboration, disciplined, innovative, openness, patient-focused and resilient.  Key Responsibilities: This position, reporting to Head of Regulatory Affairs, requires an ability to understand and evaluate all perspectives of promotions and advertising and provide clear regulatory guidance.Primary responsibilities include:Providing expert regulatory evaluation of proposed investigator materials, trial recruitment materials, advertising, promotional, medical communications, advisory board materials, and disease state materials to ensure compliance with FDA regulations, guidance, corporate standards and policies, and business objectives.Serving as Regulatory lead on the Legal, Medical and Regulatory Review Committee (LMR) for US and global materials.Interfacing with Coordinator of the LMR and assisting Commercial with the planning and prioritization of proposed promotional and disease state materials for reviews through the Veeva PromoMats process, ensuring compliance with Epizyme’s processes and standards.Providing oversight to relevant external vendors and consultants.Working closely with Legal and Regulatory counterparts to help ensure that global development strategies result in commercially viable labeling, in support of promotional claims.Owning label development and revision processes.Providing regulatory leadership and guidance to Commercial during the development, review and approval of product labelling and advertising materials.Providing effective solutions to mitigate identified regulatory risks.Appropriately escalate unresolved regulatory compliance issues.Acting as primary liaison with FDA’s Office of Prescription Drug Promotion (OPDP), including responding to agency inquiries and managing company requests for advisory review.Working with Regulatory Operations to ensure required OPDP submission of promotional materials are appropriately filed with the FDA.Working with LMR team members to provide input into improvement of systems and/or processes.Providing regulatory input on concepts and draft materials.Offering regulatory feedback for Company Core Data Sheet (CCDS) and product label development.Keeping current with industry and regulatory developments relating to advertising and promotion, including interpretation of FDA enforcement letters, interpretation of new and updated Guidance Documents for Industry, and, as applicable, evaluating related internal policies/best practices and processes.Participating in Regulatory Department, Regulatory Subteam, Commercial Functional Team, and other meetings, as needed.Participate in training of Medical Science Liaisons (MSLs), and sales and marketing personnel on promotional, labelling and advertising regulations, and product launch materials, and congress booth compliance. Education & Requirements:BA/BS Degree required, preferably in a health/life sciences or related field.Minimum of 8 years in Regulatory including ~5 years of experience as a regulatory reviewer of advertising and promotional materials within the pharmaceutical industry. Experience with FDA Subpart H pre-approval submissions strongly preferred.Strong knowledge of regulations and their interpretation relevant to prescription drug advertising, promotion and labeling.Commercial launch and advisory comment process experience desired.Require limited direction to complete standard and non-standard work.Must be innovative, driven and effective with a “can do” attitude.Must possess excellent interpersonal and communication skills.Must have the ability to build and maintain positive relationships with management, peers, and cross functional colleagues.Excellent written and verbal skills required. Must display strong analytical and problem solving skills. Attention to detail required. Epizyme, Inc. is a vibrant, entrepreneurial EEO employer committed to a diverse and dynamic workplace. Nov 13th, 2019 02:38AM Nov 13th, 2019 02:38AM Health Care Pharmaceuticals & Biotechnology
nasdaq:epzm www.epizyme.com www.epizyme.com Nov 13th, 2019 12:00AM Senior Business Systems Analyst- Quality Systems Open Information Technology Oct 17th, 2019 12:00AM Epizyme, Inc. is a clinical-stage biopharmaceutical company committed to rewriting treatment for cancer and other serious diseases through novel epigenetic medicines.  Epizyme is broadly developing its lead product candidate, tazemetostat, a first-in-class EZH2 inhibitor, with studies underway in both solid tumors and hematological malignancies, as a monotherapy and combination therapy in relapsed and front-line disease. The company is also developing a novel G9a program with its next development candidate, EZM8266, which is targeting sickle cell disease.  By focusing on the genetic drivers of disease, Epizyme's science seeks to match targeted medicines with the patients who need them.  Epizyme has assembled a world-class team with a passion for scientific innovation and a commitment to developing novel epigenetic therapies.  Join a dynamic, diverse and fun work environment consistent with Epizyme’s cultural attributes for success: camaraderie, collaboration, disciplined, innovative, openness, patient-focused and resilient.  The role Sr. Business Systems Analyst - Quality Systems is an important function within the Epizyme’s Information Technical Department and primary function is to ensure all of the Quality department’s technical and business solution needs are met.  The role reports directly to the Director of Enterprise Business Systems.Key Responsibilities: Liaison between Quality Assurance, IT and key vendors to ensure all of the Quality department’s business solution and technical requirements are met.Conducts business process analysis, requirements gathering, solution selection, project implementation and computer validation activities.Draft computer validation deliverables (e.g. validation plan, requirements, test scripts, summary reports)Provide system support for Veeva QualityDocs, Trackwise Ditigal QMS and UL ComplianceWire Learning Management System.Prepare plans/status reports and track progress on the projectsManage request intake and drive prioritization with your business partnersEnsure compliance to IT change control and SDLC proceduresCoordinate and manage application support with vendors and external consultantsFacilitate cross functional/interdepartmental ImplementationsHelp design and implement best practices Education and Requirements:BA/BS in Computer Science, Information Technology or related field3+ years of experience in a business analyst or application support role3+ years working within enterprise QMS solutions and 21 CFR Part 11 validation experiencePrior experience with Veeva QualityDocs, QMS solutions, ComplianceWire LMSPrior experience with a 21 CFR Part 11Prior experience with Cloud/SaaS applications preferredExcellent communication and project management skillsAbility to multi-task and manage multiple projects simultaneouslyAbility to work as an individual contributor and as a member of a teamLife Sciences experience is preferred Epizyme, Inc. is a vibrant, entrepreneurial EEO employer committed to a diverse and dynamic workplace. Nov 13th, 2019 02:38AM Nov 13th, 2019 02:38AM Health Care Pharmaceuticals & Biotechnology
nasdaq:epzm www.epizyme.com www.epizyme.com Nov 13th, 2019 12:00AM Director, Government Reporting Open Finance Oct 23rd, 2019 12:00AM Epizyme, Inc. is a late-stage biopharmaceutical company committed to rewriting treatment for cancer and other serious diseases through novel epigenetic medicines.  Epizyme is broadly developing its lead product candidate, tazemetostat, a first-in-class EZH2 inhibitor, with studies underway in both solid tumors and hematological malignancies, as a monotherapy and combination therapy in relapsed and front-line disease. The company is also developing a novel G9a program with its next development candidate, EZM8266, which is targeting sickle cell disease.  By focusing on the genetic drivers of disease, Epizyme's science seeks to match targeted medicines with the patients who need them.  Epizyme has assembled a world-class team with a passion for scientific innovation and a commitment to developing novel epigenetic therapies.  Join a dynamic, diverse and fun work environment consistent with Epizyme’s cultural attributes for success: camaraderie, collaboration, disciplined, innovative, openness, patient-focused and resilient.  We are searching for Director of Government Reporting and Trade to join our team. Reporting to the Head of Financial Planning and Analysis, this role will partner with the Senior Vice President, Commercial and the Commercial Leadership team to provide value-added financial and decision support. This position is a critical role within the Finance and Commercial team supporting the current and future success of our brand by ensuring compliance within our commercial contracting and government pricing initiatives while working with cross-functional business unit stakeholders. This role will oversee the accurate calculation, payment, and timely reporting of all rebates and government pricing information required for program compliance. The ideal candidate will be a self-motivated, highly collaborative, detail oriented individual who is able to meet deadlines in a fast paced environment.Key Responsibilities: Prepare, calculate, and analyze government prices such as the “Best Price” (BP), “Average Sales Price” (ASP), Average Manufacturing Price” (AMP), the “Non-Federal Average Manufacturers Price” (NonFAMP), “Federal Supply Schedule” (FSS) price, and the “Public Health Service” (PHS 340B) price.Ensure accurate and on time payment of all rebates and fees associated with rebate contracts for Managed Care Medicare Part D Coverage Gap, TriCare, and Medicaid.Validate Medicaid rebate claims data for correct unit of measure, duplicate claims and where relevant, 340B ineligible submissions.Prepare and submit required state reporting.Provide monthly timely and accurate input to the Accounting department for proper booking of accruals and other related entries on gross-to-net.Oversee the implementation and administration of Commercial contracts:  manage all chargeback transactions and member lists, and pricing changes.Ensure compliance with contractual terms, conditions and obligations throughout all customer channels.Assist in customer notification process of all contract pricing changes and other contracted product related notificationsAnalyze customer pricing and performance against defined contract metrics in conjunction with Business Insights and Analytics.Collaborate with distributors and other external stakeholders.Perform financial analyses on how the company’s rebate and chargeback liabilities are projected to impact pricing decisions, as requested by the commercial organization, FP&A and other stakeholders.Assist in the preparation of recurring and ad hoc reports on government programs; develop reporting metrics, techniques and tools, while working with data from multiple sources and across multiple timeframes.Support the development and maintenance of policies and standard operating procedures to ensure compliant operations. Key position of Secretary of the Pricing and Contracting Review Committee.Strategic Finance partner to Commercial organization providing financial leadership, guidance and insight.Drive timely results to internal and external customers and partnersSupport Commercial Leadership team on evaluating new business opportunities and decision-making support related to Government Pricing ImpactIdentify and lead special projects and analysis that provide a strategic, financial, and analytical approach to decision making. Advocate for continuous improvement initiatives Education & Requirements:Bachelor’s degree Business, Sciences or other related fieldMinimum 6 years of experience with rebate/chargeback management, government pricing, reimbursement, financial analysis or pricing/procedure management preferredCommercial Biotech/Pharmaceuticals industry experience a must. Commercial product launch experience preferredStrong technical/analytical skills to identify and solve problemsAbility to thrive in a small, dynamic and fast-paced environment – flexibility, team-oriented, collaborative work style and a positive attitudeDemonstrated self-starter with an ability to work independentlyTeam player with strong interpersonal, written and verbal communication skills; ability to contribute through open channels of communication and fostering collaborative relationshipsStrong organizational skills in order to maintain a high level of productivity, innovation, and priority-setting in order to complete assignments on-timeDeeply committed to accuracy and pride in attention to detail and creative approach to problem-solving Epizyme, Inc. is a vibrant, entrepreneurial EEO employer committed to a diverse and dynamic workplace. Nov 13th, 2019 02:38AM Nov 13th, 2019 02:38AM Health Care Pharmaceuticals & Biotechnology
nasdaq:epzm www.epizyme.com www.epizyme.com Nov 13th, 2019 12:00AM Executive Assistant Open Administrative Oct 24th, 2019 12:00AM Epizyme, Inc. is a late-stage biopharmaceutical company committed to rewriting treatment for cancer and other serious diseases through novel epigenetic medicines.  Epizyme is broadly developing its lead product candidate, tazemetostat, a first-in-class EZH2 inhibitor, with studies underway in both solid tumors and hematological malignancies, as a monotherapy and combination therapy in relapsed and front-line disease. The company is also developing a novel G9a program with its next development candidate, EZM8266, which is targeting sickle cell disease.  By focusing on the genetic drivers of disease, Epizyme's science seeks to match targeted medicines with the patients who need them.  Epizyme has assembled a world-class team with a passion for scientific innovation and a commitment to developing novel epigenetic therapies.  Join a dynamic, diverse and fun work environment consistent with Epizyme’s cultural attributes for success: camaraderie, collaboration, disciplined, innovative, openness, patient-focused and resilient.  Key Responsibilities: Completes a broad variety of administrative tasks including managing extremely active calendars, arranging complex and detailed travel plans, itineraries, and agendas completing expense reports, and compiling documents for travel-related meetingsOrganize and coordinate key multi-functional meetings, requiring effective communication and interaction with internal and external stakeholders, sometimes in different time zonesLeverages excellent MS Office skills to provide robust presentation, document, and spreadsheet supportManages, tracks, and files a range of highly confidential documents.Provides leadership and positive attitude to build relationships crucial to the success of the organization, including superb, collaborative working relationships with other Executive AssistantsSuccessfully completes critical aspects of deliverables with a hands-on approach, including tracking important events, documents, and milestones and ensuring appropriate information distributionPrioritizes conflicting needs; handles matters expeditiously, proactively, and follows through on projects to successful completion, often with deadline pressuresAnswer office phones for Executive acting as “gatekeeper” to screen out sales/cold calls and make sure important calls get throughRedirect to other departments or relay messages as needed. Plans, coordinates and ensures Executive schedules are followed and respectedEducation & Requirements:Bachelor's degree required.  A minimum of 8 years of experience supporting C-Level Executives. Proficiency in Microsoft Office and Adobe Acrobat.  Strong organizational skills that reflect ability to achieve high performance goals and to prioritize multiple tasks seamlessly with excellent attention to detail. Very strong interpersonal skills and the ability to build relationships with stakeholders, including staff, board members, and external partners.  Expert level written and verbal communication skills. Demonstrated proactive approaches to problem-solving with strong decision-making capability.  Emotional maturity.  Proven ability to handle confidential information with discretion, be adaptable to various competing demands, and demonstrate the highest level of customer/client service and response.Epizyme, Inc. is a vibrant, entrepreneurial EEO employer committed to a diverse and dynamic workplace. Nov 13th, 2019 02:38AM Nov 13th, 2019 02:38AM Health Care Pharmaceuticals & Biotechnology
nasdaq:epzm www.epizyme.com www.epizyme.com Nov 13th, 2019 12:00AM Manager/Senior Manager, Corporate Affairs Open Corporate Affairs Oct 30th, 2019 12:00AM Epizyme, Inc. is a late-stage biopharmaceutical company committed to rewriting treatment for cancer and other serious diseases through novel epigenetic medicines. Epizyme is broadly developing its lead product candidate, tazemetostat, an oral, first-in-class EZH2 inhibitor, with studies underway in both solid tumors and hematological malignancies, as a monotherapy and combination therapy in relapsed and front-line disease. The company is also exploring additional molecules in its novel G9a inhibitor program. By focusing on the genetic drivers of disease, Epizyme's science seeks to match targeted medicines with the patients who need them. Epizyme has assembled a world-class team with a passion for scientific innovation and a commitment to developing novel epigenetic therapies.  Join a dynamic, diverse and fun work environment consistent with Epizyme’s cultural attributes for success: camaraderie, collaboration, disciplined, innovative, openness, patient-focused and resilient.  As a member of the Corporate Affairs team, the Manager / Senior Manager, Corporate Affairs will be responsible for the development and implementation of communication tactics for both external and internal audiences that enhance Epizyme’s reputation. Reporting to the Senior Director, Corporate Affairs, this individual will be responsible for the day-to-day management of Epizyme’s corporate social media channels and support internal communications efforts for the organization. Key Responsibilities: Day-to-day management of Epizyme’s corporate social media channels, including development of social media content, engagement with online community, and analysis of key digital/social metricsLeverage digital/social media expertise to support cross-functional team membersLead and coordinate internal communications activities including in-person events (town halls, staff meetings) and employee give-aways/print materialsManage company intranet to encourage employee engagement with the company’s mission, vision, and cultureSupport HR team on key organizational change management and communications efforts, identifying creative strategies to foster connection with employeesDevelop and foster strong working relationships with cross-functional colleagues and leaders across all levels of the organization; ensure cross-functional alignment of key strategies and messaging as relevantWork closely with PR agency partner on key deliverables, managing timelines and budgetMaintain confidentiality as it pertains to sensitive scientific data, HIPAA-protected patient information, SEC-protected filings, and other designated topics, at all timesSupport Corporate Affairs team with other responsibilities as assigned, including projects related to the company’s corporate website, and other communications activities as needed Education & Requirements:5-7 years of experience working in communications, either at a PR agency or with a biotech/pharmaceutical companyBachelor’s degree requiredExcellent writing, editing, and presentation skills; superior organizational and budgeting skills; detail-orientedSuperb communication skills, tact, composure, and confidentiality in order to manage sensitive information and participate in key inter-departmental interactionsExperience with social media platforms and analytics/tools, including, but not limited to Twitter, LinkedIn, YouTube, Hootsuite, Sprout Social, etc.Working knowledge of digital/social media best practices and trends, while understanding the nuances of operating in a regulated environment to incorporate into the planning and execution of core tacticsAbility to take on new challenges, define new processes, and navigate situations where flexibility to accomplish goals may be requiredAdept at dealing with ambiguity and striving for clarity, path forwardSelf-starter with strong time management skills with the ability to prioritize multiple projects, meeting deadlines and delivering high-quality workClear commitment to complying with company, legal and government regulationsOperate in a manner consistent with Epizyme’s cultural attributes for success: camaraderie, collaboration, disciplined, innovative, openness, patient-focused, and resilient  Epizyme, Inc. is a vibrant, entrepreneurial EEO employer committed to a diverse and dynamic workplace. Nov 13th, 2019 02:38AM Nov 13th, 2019 02:38AM Health Care Pharmaceuticals & Biotechnology
nasdaq:epzm www.epizyme.com www.epizyme.com Nov 13th, 2019 12:00AM Associate Director, Drug Substance Development & Manufacturing Open Pharmaceutical Sciences Nov 4th, 2019 12:00AM Epizyme, Inc. is a late-stage biopharmaceutical company committed to rewriting treatment for cancer and other serious diseases through novel epigenetic medicines.  Epizyme is broadly developing its lead product candidate, tazemetostat, a first-in-class EZH2 inhibitor, with studies underway in both solid tumors and hematological malignancies, as a monotherapy and combination therapy in relapsed and front-line disease. The company is also developing a novel G9a program with its next development candidate, EZM8266, which is targeting sickle cell disease.  By focusing on the genetic drivers of disease, Epizyme's science seeks to match targeted medicines with the patients who need them.  Epizyme has assembled a world-class team with a passion for scientific innovation and a commitment to developing novel epigenetic therapies.  Join a dynamic, diverse and fun work environment consistent with Epizyme’s cultural attributes for success: camaraderie, collaboration, disciplined, innovative, openness, patient-focused and resilient.  Reporting to the Senior Director, Drug Substance Development & Manufacturing, the Associate Director, Drug Substance Development & Manufacturing will work closely with other CMC functions and multidisciplinary project teams to ensure delivery of high-quality drug substance to support clinical and commercial objectives. Responsibilities Works with external labs and manufacturers to develop and scale efficient processes for small molecule manufacture, providing high-quality drug substance to support clinical and commercial programs.Supervises activities at contract manufacturers, including plant-floor support, and manages consultants as needed to ensure effective execution of drug substance manufacturing activities and attainment of goals.Contributes top-tier expertise in chemical process development to identify and implement safe and scalable syntheses for starting materials, intermediates, and final drug substance.Develops and leads phase-appropriate drug substance project plans: prepares proposal requests, contributes to vendor selection, and manages the successful execution of plans consistent with operating budget and corporate objectives.Authors development reports, critically reviews batch documentation, and contributes to the preparation of the drug substance sections of regulatory documents (IND, IMPD, NDA).Effectively integrates drug substance activities with those of sister CMC functions, including Drug Product Development & Manufacturing, Analytical Development, Quality Assurance, and Regulatory Affairs.Effectively and professionally represents the drug substance function on project-level cross-functional teams, collaborating to define development strategy and meet overall program goals and timelines. Education & RequirementsPhD. in chemistry and 7-10 years of relevant experience in small molecule drug substance development and manufacturing.Direct experience with small-molecule process scale-up. Demonstrated ability to translate laboratory results into successful manufacture of drug substance on pilot and commercial scales.Expertise in synthetic organic chemistry and working knowledge of associated analytical techniques.Strong knowledge of GMP requirements for drug substance manufacture and associated analytical activities, as well as broader drug development guidelines and regulations (ICH, FDA, and EMA).Experience working across both early and late phases of clinical development preferred.Ability to lead, motivate, and engage external partners to ensure successful delivery of projects.Solid oral and written communication skills, with experience presenting to diverse audiences, and preparing technical reports and regulatory filings.Strong problem-solving skills and ability to overcome process challenges while working within project timelines.Periodic travel to support manufacturing operations will be required (approximately 15% of time).Clear alignment with Epizyme’s Core Values: Collaboration, Disciplined, Innovative, Openness, Patient-Focused, and Resilient. Epizyme, Inc. is a vibrant, entrepreneurial EEO employer committed to a diverse and dynamic workplace. Nov 13th, 2019 02:38AM Nov 13th, 2019 02:38AM Health Care Pharmaceuticals & Biotechnology

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