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nasdaq:alks
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www.alkermes.com
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www.alkermes.com
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Sep 21st, 2021 12:00AM
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(Contractor) Digital Marketing
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Open
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11257
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New Search
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Position Description
(Contractor) Digital Marketing
Job ID
11257
Location
Waltham, MA
Field Locations
Apply Now
Company Overview
Alkermes plc is a fully-integrated, global biopharmaceutical company developing innovative medicines in the fields of neuroscience and oncology. The company has a portfolio of proprietary commercial products focused on addiction, schizophrenia and bipolar I disorder, and a pipeline of product candidates in development for neurodegenerative disorders and cancer. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. Description: **Please note this is a contract role**
Alkermes is looking to fill a contract role on the LYBALVI commercial team: CONTRACTOR in Digital Marketing. This position will play a key role in contributing to the launch of ALKS 3831 by supporting the launch and post-launch rollout of a broad digital education effort for patients and HCPs.
Key Responsibilities:
Contribute to the development and deployment of digital marketing campaigns. This will likely be a mix of HCP and consumer programs.
Ensure consistent messaging and brand voice and content across channels and tactics
Manage multimedia content delivery across multiple websites and other digital channels
Manage approval process for digital marketing tactics and oversee effective implementation/deployment with agency partners
Contribute to brainstorming new and creative strategies to reach key stakeholder audiences
Work with internal partners, including commercial operations and IT, to continually refine operating procedures
Collaborate with key vendor and agency partners
Keep current with emerging technologies
Manage other brand launch and other marketing initiatives as needed
Minimum Education & Experience Requirements:
A minimum of 5-7 years’ experience in pharmaceutical/healthcare product marketing and digital marketing
Experience across digital marketing tactics, including websites, media, SEO, SEM, CRM, and Social Media
Understanding of the FDA promotional guidelines and approval process
Bachelor’s degree in marketing or related field
Skills and Knowledge Requirements:
Creative, with experience in devising campaigns targeted and personalized to specific audiences
Knowlegeable of digital marketing tools (i.e. Marketo, Google Analytics)
Ability to effectively plan, prioritize, and execute simultaneous projects
Team player with proven ability to work collaboratively with other internal functions (i.e., marketing, IT, commercial operations)
Strong interpersonal and written communication skills
Understanding of industry code of conduct and ethics
Travel Requirements:
Optional occasional in-person meetings
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, color, religion, sex, sexual orientation, gender expression and identity, national origin, ancestry, age, mental and physical disability, genetic information, any veteran status, military status or application for military service, or membership in any other category protected under applicable law.
Experience Level:
Mid-Senior Level
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Apply Now
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Sep 21st, 2021 01:29PM
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Sep 21st, 2021 01:29PM
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Alkermes
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Health Care
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Pharmaceuticals & Biotechnology
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nasdaq:alks
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www.alkermes.com
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www.alkermes.com
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Sep 21st, 2021 12:00AM
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Associate Director, Manufacturing-Filling
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Open
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11123
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New Search
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Position Description
Associate Director, Manufacturing-Filling
Job ID
11123
Location
Wilmington, OH
Field Locations
Apply Now
Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines in the fields of neuroscience and oncology. The company has a portfolio of proprietary commercial products focused on addiction and schizophrenia, and a pipeline of product candidates in development for schizophrenia, bipolar I disorder, neurodegenerative disorders and cancer. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes' website at www.alkermes.com.
This position provides leadership to the manufacturing department engaged in the production of both clinical and commercial drug products. The Associate Director ensures that the production department is adequately staffed with properly trained, knowledgeable employees who perform their duties according to approved Manufacturing directions, Standard Operating Procedures, Alkermes guidelines for safety and environmental compliance, as well as current European and US Good Manufacturing Practices. The Associate Director is responsible for assuring production schedules are met in an efficient and timely manner.
KEY DUTIES:
Provide leadership to the manufacturing of quality pharmaceutical drug products to support both commercial and clinical needs of the Wilmington manufacturing facility.
Communicate effectively and establish productive working relationships with Materials Mgmt, Quality Control & Quality Assurance.
Works on complex problems involving intangible variables.
Provides guidance/troubleshooting abilities on manufacturing issues.
Provide leadership and management for direct reports: Production Managers, Commercial/Clinical Team Leaders, and Manufacturing Compliance Specialist.
Participate in routine meetings: Wilmington Tech Teams, Quality Review Board, Material Review Board, Production etc.
Manage the production dept. in the areas of quality, compliance, housekeeping, efficiency, planning, customer service, training and employee development
Review and approve GMP documents for use in production and assure that completed documents are accurate and complete prior to forwarding to Quality Assurance for archiving
Approve protocols, coordinate the validation activities related to production equipment and facilities, and approve final validation reports.
SPECIFIC COMPETENCIES REQUIRED:
Communicates Directly
Communicates opinions, facts and thoughts with clarity, transparency and honesty
Seeks multiple perspectives and listens openly to others’ points of view
Enables and demonstrates the courage to speak up on issues and risks as well as on the good news
Develops employees
Continuously builds a high-performance diverse team of people to achieve objectives
Develops self and others to improve performance in current role and to prepare for future roles
Seeks and welcomes feedback and responds to coaching
Provides frequent feedback and coaching to others on ways to improve performance
Recognizes and celebrates successes
Drives Performance
Consistently delivers on commitments
Demonstrates ownership of results within (and beyond) area of responsibility
Sets clear and high expectations and holds self and others accountable for decisions and results achieved
Develops contingency plans and meets challenges necessary to execute business and action plans
Develops and applies unique ideas and new methods to achieve higher performance and excellence
Collaborates
Works across organizational, and functional boundaries to achieve company goals
Builds and maintains strong relationships with team members, and other functions
Works cooperatively with others in order to meet group and organizational goals
Leads Strategically
Creates a sense of purpose or vision for self, group or team
Translates broad strategies into specific objectives and action plans
Makes critical choices that support strategy and ultimately the end customers
Aligns personal, team and/or department goals and objectives with organization goals and business strategy and takes actions to achieve them
Creates a unified and seamless team
Provides direction to others that clarifies their expectations and role
PERSONAL ATTRIBUTES:
A confident, self starter with an uncompromising commitment to integrity and quality.
A leader of people who uses influence, coaching skills and persuasion to accomplish objectives in a cross-functional team environment.
An analytical thought process, collaborative, multi-task oriented and an attention to detail.
The confidence to provide advice, the interpersonal skills to deliver the message in an acceptable manner and the patience to work through the issues.
A hands-on style, strong work ethic and an interpersonal style that will be compatible with Alkermes culture.
The ability to set the vision and focus on where to take a business and the courage, drive and discipline to execute the plan.
Well developed planning and organizational skills and ability to work autonomously with minimal support.
Superior communication skills before large and varied audiences.
An open communicator who enjoy working cross-functionally throughout an organization to achieve desired results.
EDUCATION:
The qualified candidate must have a Bachelor degree in a Science of Engineering Discipline
EXPERIENCE:
Minimum of 10 years Pharmaceuticals production experience, to include five years related supervisory experience. Demonstrated ability to motivate exempt and non-exempt employees and demonstrated management skills, (i.e., business knowledge, leadership, communication, ability to analyze technical issues, conflict resolution). Thorough knowledge of cGMPs.
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.
#LI-AH1
Experience Level:
Director
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Apply Now
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Sep 21st, 2021 01:29PM
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Sep 21st, 2021 01:29PM
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Alkermes
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Health Care
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Pharmaceuticals & Biotechnology
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nasdaq:alks
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www.alkermes.com
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www.alkermes.com
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Sep 21st, 2021 12:00AM
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Associate Director/Director, Biostatistics
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Open
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10625
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New Search
Login Page
Position Description
Associate Director/Director, Biostatistics
Job ID
10625
Location
Waltham, MA
Field Locations
Apply Now
Associate Director/Director, Biostatistics
Alkermes Overview
Alkermes, Inc. is the U.S. operating company of Alkermes plc, a fully integrated, global biopharmaceutical company that applies its scientific expertise and proprietary technologies to research, develop and commercialize, both with partners and on its own, pharmaceutical products that are designed to address unmet medical needs of patients in major therapeutic areas. Alkermes has a diversified portfolio of marketed products focused on central nervous system disorders such as addiction and schizophrenia and a pipeline of product candidates in the fields of neuroscience and oncology. Headquartered in Dublin, Ireland, Alkermes has a research and development (“R&D”) center in Waltham, Massachusetts; an R&D and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio.
The following position is for Alkermes, Inc.
Position Summary:
The Associate Director or Director of Biostatistics will support drug development activities and decision-making encompassing Phase I-IV studies. This includes guidance on designing studies, selecting appropriate and innovative statistical methods, analyses, interpretation, and reporting of study results.
Duties and Responsibilities:
Work with a group of biostatisticians to develop and execute statistical strategy, design, and analyses for clinical trials focuses on Oncology, Psychiatry, or Neurology using appropriate and innovative statistical methods
Effectively interact with members in other functions including medical, regulatory, safety, clinical operation, and translational medicine for strategic planning to ensure optimized clinical development in accordance with corporate objective
Provide statistical input to project team and senior management.
Provide statistical input and content in support of regulatory interactions and submissions- briefing books, and integrated summary documents.
Effectively coordinate statistical endeavors with outside organizations, CROs and consultants
Provide guidelines and standards to CROs and internal programing team to ensure quality of deliverables
Identify and implement emerging new ways of doing clinical development and new methodologies
Participate in department initiatives and research forums
Basic Requirements for Associate Director:
Ph.D. in Statistics or Biostatistics
5+ years of clinical research and drug development experience
Basic Requirements for Director:
Ph.D. in Statistics or Biostatistics
10+ years of clinical research and drug development experience
Preferred Requirements:
Recent experience working in the field of Oncology, Psychiatry, or Neurology is a plus
In-depth knowledge of methodologies applied in clinical trials with focus on registration and life-cycle management
Experience of interactions with regulatory agencies- US and Non-US is a plus
Strong analytical skills and demonstrated experience in gathering, interpreting and analyzing data in clinical research and drug development
Strong communication and interpersonal skills; ability to interact with cross-functional teams
Flexible to changing priorities, detail-oriented, works well under pressure
Ability to communicate statistical information to non-scientists, willingness to educate internal team
Travel Expectations:
Travel domestic and international- up to 15%
#LI-HB1
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic inf ormation, veteran status, military status, application for military service or any other class protected by state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.
Experience Level:
Mid-Senior Level
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Apply Now
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Sep 21st, 2021 01:29PM
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Sep 21st, 2021 01:29PM
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Alkermes
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Health Care
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Pharmaceuticals & Biotechnology
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nasdaq:alks
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www.alkermes.com
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www.alkermes.com
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Sep 21st, 2021 12:00AM
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Contract Senior Research Associate/Scientist: In vitro CNS
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Open
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11347
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New Search
Login Page
Position Description
Contract Senior Research Associate/Scientist: In vitro CNS
Job ID
11347
Location
Waltham, MA
Field Locations
Apply Now
Alkermes Overview
Alkermes, Inc. is the U.S. operating company of Alkermes plc, a fully integrated, global biopharmaceutical company that applies its scientific expertise and proprietary technologies to research, develop and commercialize, both with partners and on its own, pharmaceutical products that are designed to address unmet medical needs of patients in major therapeutic areas. Alkermes has a diversified portfolio of marketed products focused on central nervous system disorders such as addiction and schizophrenia and a pipeline of product candidates in the fields of neuroscience and oncology. Headquartered in Dublin, Ireland, Alkermes has a research and development (“R&D”) center in Waltham, Massachusetts; an R&D and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio.
The following position is for Alkermes, Inc.
Contractor Position Overview:
Alkermes is seeking a highly motivated and talented scientist to join the in vitro CNS team to support drug discovery. This is an exciting bench focused position and the candidate will contribute to various projects from target validation to clinical candidate selection to drive therapeutic programs forward. The candidate should have a track record of employing multiple cellular and molecular biological techniques to address scientific questions, and considerable experience in working to address challenging issues and have deep expertise in cellular pharmacology approaches, assays, and technologies.
Key Responsibilities:
Primary responsibility is to develop and execute in vitro assays to support target validation, compound screen and characterization, delivery of clinical candidates for CNS disorders
Build functional assays related to neurodegenerative diseases and test the efficacy of compounds.
Collaborate with scientists in CNS disorders team to assess molecular and biochemical endpoints
Present scientific findings in cross-functional project team meetings, write protocols and reports, document results in laboratory notebooks
TECHNICAL SKILLS
Aseptic mammalian cell lines culture. Primary neuronal culture and iPSC derived models experience preferred.
Experience with molecular biology and biochemistry work (RNA and DNA extraction, real-time PCR, Western blotting, ELISA, MSD)
Experience with plasmid transfection and siRNA knock down
Cell based assay development and high content imaging experience is a plus
PERSONAL SKILLS
Self-motivated and great time management. Enthusiastic about drug discovery and ability to work under pressure and drive projects towards aggressive timelines
Strong interpersonal skills and enjoy working with other groups. Excellent communication skills outstanding organizational and documentation skills.
MINIMUM EDUCATION AND EXPERIENCE :
PhD with 0-2 years, M.S. with 2-4 years, or B.S. with 4-8 years of experience.
Neuroscience and prior industry experience is preferable.
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic inf ormation, veteran status, military status, application for military service or any other class protected by state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.
#LI-AB1
Experience Level:
Associate
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Sep 21st, 2021 01:29PM
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Sep 21st, 2021 01:29PM
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Alkermes
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Health Care
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Pharmaceuticals & Biotechnology
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nasdaq:alks
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www.alkermes.com
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www.alkermes.com
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Sep 21st, 2021 12:00AM
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Contract, Research Associate, Biology
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Open
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11245
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New Search
Login Page
Position Description
Contract, Research Associate, Biology
Job ID
11245
Location
Waltham, MA
Field Locations
Apply Now
Alkermes Overview
Alkermes, Inc. is the U.S. operating company of Alkermes plc, a fully integrated, global biopharmaceutical company that applies its scientific expertise and proprietary technologies to research, develop and commercialize, both with partners and on its own, pharmaceutical products that are designed to address unmet medical needs of patients in major therapeutic areas. Alkermes has a diversified portfolio of marketed products focused on central nervous system disorders such as addiction and schizophrenia and a pipeline of product candidates in the fields of neuroscience and oncology. Headquartered in Dublin, Ireland, Alkermes has a research and development (“R&D”) center in Waltham, Massachusetts; an R&D and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio.
The following position is for Alkermes, Inc.
Job Description
Alkermes has an excellent opportunity for a highly talented biologist with a strong background in cell / molecular biology. The research associate level position is currently a contract research scientist for 12 months with possibility of renewal.
This position will be an integral part of the in vitro pharmacology group and the ideal candidate will help drive assay support in disease areas with a primary focus in oncology. This is predominantly a laboratory/wet bench-based role and requires strong attention to details, ability to deliver quality data in a timely manner and work effectively with team members, both internal and external (CRO) in support of Alkermes drug discovery efforts. The candidate will support routine cell-based assays for compound profiling and deliver with the support of supervisor in vitro ‘proof of concept’ work for targets of interest. As well as part take in the development of phenotypic and mechanistic assays using cutting edge technologies to support screening cascades and/or prosecuting functional roles of targets in secondary assays of biological relevance e.g., human primary tumor tissues. Familiarity with disease mechanisms in Oncology and Immuno-Oncology is preferred. Data analysis, interpretation, documentation and presentation skills is required.
Minimum Qualifications
BS with 1-3 years of experience in a relevant scientific area or MS in cell biology, oncology, immunology, or related subject
Familiarity with culturing cell lines of diverse lineages as well as deriving and maintaining cell lines
Hands-on experience with techniques pertaining to molecular and cellular biology (e.g., PCR, RT-PCR, western blotting, ELISA, cell staining/flow cytometry, cytotoxicity assays, intracellular protein interaction assays).
Conducts experiments after discussion of the design and strategy with the supervisor.
Contributes to assay development, optimization and validation.
Performs literature searches and analysis as needed for assay development.
Experience in Biochemical/cell-based assay development using a variety of techniques such as FRET, MSD, HTRF, ALPHALisa based readouts is preferred but not required
Develop mechanism-based in vitro assays involving primary human immune cells to drive drug discovery with the support of supervisor
The successful candidate must be detail orientated and have the ability to work independently while also being a team player
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.
#LI-AB1
Experience Level:
Entry Level
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Sep 21st, 2021 01:29PM
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Sep 21st, 2021 01:29PM
|
Alkermes
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Health Care
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Pharmaceuticals & Biotechnology
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nasdaq:alks
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www.alkermes.com
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www.alkermes.com
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Sep 21st, 2021 12:00AM
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Contracts Manager
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Open
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11333
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New Search
Login Page
Position Description
Contracts Manager
Job ID
11333
Location
Waltham, MA
Field Locations
Apply Now
Alkermes plc (Nasdaq: ALKS) is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases and immuno-oncology. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for diseases that include schizophrenia, depression, addiction, multiple sclerosis and cancer. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio.
Contracts Manager
Overview
As part of a multi-discipline Legal Department, you will have an opportunity to be part of a dynamic Legal Team focused on providing client service-oriented support to various key stakeholders within the Company as well as within the Legal Department. This role plays a vital role in the contracting process within the company. To be successful, you will have previous experience working in a fast-paced environment, and drafting, reviewing and negotiating a high volume of contracts on various subjects.
Responsibilities
In this position, you will be expected to:
Independently review, prepare and negotiate a high volume of a biotech contracts, including master service agreements, consulting agreements, confidentiality agreements, SAS agreements, publication agreements, commercial services agreements, termination notices, amendments among others.
Collaborate closely and efficiently with internal business owners to advise them on the range of issues involved in the contract, to provide practical problem-solving advice and to educate clients on the potential business and legal risks that can arise throughout the life cycle of a contract.
Coordinate with internal functions such as Finance, Strategic Sourcing, and Information Security to support compliance with internal approval procedures.
Act as a system administrator for the legal contracts management system.
Identify and escalate issues and risks, current and potential, to internal counsel as needed.
Demonstrate strong organizational and prioritization skills needed to manage multiple, parallel contract projects at any given time
Contribute to the development of processes, practices and templates to standardize and streamline the contracting process, including training efforts.
Engage collaboratively with Legal Team members as needed, across other areas.
Qualifications
This role is open to candidates with and without a J.D. Prior contracting experience in a fast-paced, high-volume in-house biotech or life sciences setting is strongly preferred. A demonstrated ability to win the confidence of clients and to clearly explain complex legal matters to stakeholders is a must for this role. Other essential skills include: attention to detail, commitment to integrity and ethics, strong collaboration and teamwork, ability to maintain professionalism under pressure, and a sense of humor.
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.
Experience Level:
Mid-Senior Level
Back
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Apply Now
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Sep 21st, 2021 01:29PM
|
Sep 21st, 2021 01:29PM
|
Alkermes
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Health Care
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Pharmaceuticals & Biotechnology
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nasdaq:alks
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www.alkermes.com
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www.alkermes.com
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Sep 21st, 2021 12:00AM
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Director, Regulatory Affairs CMC Biologics
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Open
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11281
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New Search
Login Page
Position Description
Director, Regulatory Affairs CMC Biologics
Job ID
11281
Location
Waltham, MA
Field Locations
Apply Now
Director, Regulatory Affairs CMC Biologics
Alkermes Overview
Alkermes, Inc. is the U.S. operating company of Alkermes plc, a fully integrated, global biopharmaceutical company that applies its scientific expertise and proprietary technologies to research, develop and commercialize, both with partners and on its own, pharmaceutical products that are designed to address unmet medical needs of patients in major therapeutic areas. Alkermes has a diversified portfolio of marketed products focused on central nervous system disorders such as addiction and schizophrenia and a pipeline of product candidates in the fields of neuroscience and oncology. Headquartered in Dublin, Ireland, Alkermes has a research and development (“R&D”) center in Waltham, Massachusetts; an R&D and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio.
The following position is for Alkermes, Inc.
Overview
Great Science, Deep Compassion, Real Impact
Alkermes is offering exciting opportunities through our commitment to work together to help improve the lives of people living with serious mental illness, addiction and cancer.
We are inspired by the courage and determination of individuals living with complicated and often difficult-to-treat diseases. We have a portfolio of proprietary commercial products focused on addiction and schizophrenia, and a pipeline of product candidates in development for schizophrenia, bipolar I disorder, neurological disorders and cancer.
Regulatory Affairs CMC supports a portfolio of small molecule and biologics development programs and commercial products across multiple locations and is committed to providing the best strategy every time through dedicated teamwork, professional excellence, and collaboration at every opportunity.
As Director, Regulatory Affairs CMC Biologics based out of our Waltham, MA office, you will be responsible for strategy development and implementation for an emerging biologics platform. You will oversee CMC regulatory submissions supporting global clinical development and commercial marketing authorizations, engaging across the business and with external partners to establish and maintain high quality submissions. As a member of the Regulatory CMC leadership team you will guide and mentor colleagues and champion the development and establishment of best practices across platforms and locations.
Your responsibilities include:
Providing regulatory and scientific expertise and leadership to shape CMC strategies for biologics product development and commercialization.
Ensuring high-quality and on-time submissions, including for INDs, IMPDs, CTAs and BLAs, that align with company strategies and Health Authority requirements.
Preparing for and conducting Health Authority CMC meetings, developing meeting information packages and overseeing responses to information requests.
Representing Regulatory Affairs on working groups and teams.
Developing and implementing best practices based on current and emerging industry trends, and relevant Health Authority guidance and regulations
Basic Requirements:
Bachelor of Science in a scientific discipline
Eight years biopharmaceutical experience
Four years Regulatory CMC biopharmaceutical experience
Preferred Requirements:
Prior leadership experience with demonstrated ability to effectively manage and mentor.
Focus on developing collaborative working relationships with internal colleagues and external partners.
Familiarity with relevant Health Authority regulations, guidelines and trends (FDA, EMA, ICH, Health Canada, ISO, WHO)
Advanced writing skills with ability to deliver high quality regulatory documents
Excellent oral communication skills
Ability to influence decisions and help develop solutions
Commitment to continuous improvement and best practices
Oncology product experience preferred
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.
#LI-HB1
Experience Level:
Director
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Apply Now
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Sep 21st, 2021 01:29PM
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Sep 21st, 2021 01:29PM
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Alkermes
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Health Care
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Pharmaceuticals & Biotechnology
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nasdaq:alks
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www.alkermes.com
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www.alkermes.com
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Sep 21st, 2021 12:00AM
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Director/Senior Director, In Vitro Pharmacology
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Open
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11086
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New Search
Login Page
Position Description
Director/Senior Director, In Vitro Pharmacology
Job ID
11086
Location
Waltham, MA
Field Locations
Apply Now
Alkermes, Inc. is the U.S. operating company of Alkermes plc, a fully integrated, global biopharmaceutical company that applies its scientific expertise and proprietary technologies to research, develop and commercialize, both with partners and on its own, pharmaceutical products that are designed to address unmet medical needs of patients in major therapeutic areas. Alkermes has a diversified portfolio of marketed products focused on central nervous system disorders such as addiction and schizophrenia and a pipeline of product candidates in the fields of neuroscience and oncology. Headquartered in Dublin, Ireland, Alkermes has a research and development (“R&D”) center in Waltham, Massachusetts; an R&D and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio.
The following position is for Alkermes, Inc.
POSITION SUMMARY:
Alkermes has an exciting new opportunity for a talented scientist to join our Research Organization as Director/Senior Director, In Vitro Pharmacology, to lead an in vitro research team to prosecute early stage targets for advancement into our pipeline within our core scientific areas of the company. The successful candidate will be well-experienced in drug discovery fundamentals and have a track record of successfully initiating and managing biochemical, biophysical and cell-based assays. Additionally, the candidate should have experience in leveraging multiple technologies to answer key scientific questions. Experience in working with both internal and external partners (e.g. academic labs, CROs, business partners from the biopharmaceutical industry) to develop strategy and design studies is also expected. Exceptional cross-functional leadership and communication skills as well as experience in leading drug discovery teams are necessary attributes. Familiarity with disease mechanisms in Oncology/Immuno-Oncology and CNS disorders is preferred.
RESPONSIBILITES:
Scientific and management leadership of the In Vitro Pharmacology team to continue an environment that promotes collaboration, teamwork and innovative science.
Effectively support multiple drug discovery projects via the design, implementation and interpretation of relevant and robust biochemical, biophysical and cell-based assays.
Collaborate with cross-functional leaders, including but not limited to Biology, Chemistry, Modeling and other Project Team Leaders to continuously align on project priorities, objectives, and outcomes.
Oversee the management and contracts of external CROs, academic, and business partners, including outreach, relationship building, design of collaborative research workplans, study monitoring, technical optimization, and maintaining efficient workflows associated with in vitro assays to meet aggressive timelines.
Provide support and direction to project teams including taking on Project Leader responsibility should the opportunity arise.
Prepare technical reports to support program reviews, publications and IND submissions.
Responsible for ensuring compliance with company established practices and procedures, including laboratory notebooks (ELN), digital data, quality and regulatory guidelines and safety standards.
BASIC QUALIFICATIONS:
PhD or equivalent in a relevant scientific area, and 10+ years (Director) or 14+ years (Senior Director) of experience in the Pharma industry with roles of increasing responsibility in driving in vitro science across all stages of drug discovery and development with demonstrated experience with optimizing and executing high quality biochemical, biophysical, and cell-based assays.
Demonstrated ability to work seamlessly in a cross-functional matrixed environment.
Ability to independently define key scientific questions and design rigorous experiments in collaboration with internal and external partners to answer these questions.
Ability to foresee possible obstacles and roadblocks and to develop and implement timely contingency plans.
Strong history of developing top-tier talent, including but not limited to PhD level scientists.
PREFERRED QUALIFICATIONS:
Ability to function productively with the utmost integrity and professionalism in a highly dynamic, matrixed, fast moving environment.
Excellent verbal and written communication skills, including strong formal presentation skills and the ability to communicate complex scientific information in an understandable manner.
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.
#LI-AB1
Experience Level:
Director
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Sep 21st, 2021 01:29PM
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Sep 21st, 2021 01:29PM
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Alkermes
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Health Care
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Pharmaceuticals & Biotechnology
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nasdaq:alks
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www.alkermes.com
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www.alkermes.com
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Sep 23rd, 2021 12:00AM
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Associate Director, Artwork and Package Design
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Open
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11310
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New Search
Login Page
Position Description
Associate Director, Artwork and Package Design
Job ID
11310
Location
Waltham, MA
Field Locations
Apply Now
Alkermes Overview
Alkermes, Inc. is the U.S. operating company of Alkermes plc, a fully integrated, global biopharmaceutical company that applies its scientific expertise and proprietary technologies to research, develop and commercialize, both with partners and on its own, pharmaceutical products that are designed to address unmet medical needs of patients in major therapeutic areas. Alkermes has a diversified portfolio of marketed products focused on central nervous system disorders such as addiction and schizophrenia and a pipeline of product candidates in the fields of neuroscience and oncology. Headquartered in Dublin, Ireland, Alkermes has a research and development (“R&D”) center in Waltham, Massachusetts; an R&D and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio.
The following position is for Alkermes, Inc.
Associate Director, Artwork and Pack Design Processes
Position Summary
The Associate Director, Artwork and Pack Design Processes is responsible to establish best in class procedures, work instructions, checklists, and forms that support an end to end artwork process. Examples of procedures that will need to be developed include submission and commercial artwork, dielines, packout drawings, shipper labels, style guides, brand protection etc. The process must include activities to negotiate change timelines and ensure implementation is executed as agreed.
This role will be responsible to establish a set of metrics that are tracked to ensure the various processes are in control. Process governance is to be established and metrics will be presented to cross functional management. CAPA management and continuous improvement activities will be important deliverables from this role.The ideal candidate will be experienced in pharmaceutical package requirements, process improvement, system design, and training stakeholders in a clinical, pre-commercial, and commercial environment. This position requires a motivated team player who can align with and support the Alkermes business principles, mission, objectives, and goals.
Essential Areas of Responsibility
Collaborate, develop and maintain relationships with internal and external partners (including but not limited to Commercial, R&D, Regulatory Affairs, Quality, Supply Chain, CMO’s, Printers) to deliver all artwork and packaging requirements
Review existing documentation and identify any process gaps.
Develop procedures and all associated work instructions, forms, checklists, and other best practice tools required for an industry leading artwork service.
Ensure individual procedures are documented with clear steps, ownership and handoffs as a project transitions from each phase.
Develop, establish, and maintain packaging standards. Standards should include innovation focus and appropriate use of smart technology and systems to facilitate seamless transition from Clinical to Pre-commercial and into Commercial packaging environments.
Support implementation, documentation, user training, and maintenance of artwork management solution.
Manage quality system workflows related to CAPA management for packaging processes
Maintain and enhance job knowledge by participating in educational opportunities; use of professional publications; alignment with professional organizations/societies, maintaining personal networks; monitoring FDA guidelines and requirements, etc
Establish and manage ongoing metrics and KPI’s for labeling and packaging activities
Assist with preparation of program budgets
Identify continuous improvement and best practice projects for artwork and packaging, and lead cross-functional teams implementating projects
Competencies
The candidate will be a leader, with broad awareness of resources and best practices across the pharmaceutical packaging industry, and a track record of managing packaging and labeling operations.
Strong understanding of cGMP requirements, and associated regulatory considerations in a commercial and clinical pharmaceutical packaging environment
Strong project management and operations skills. Working knowledge of packaging artwork service processes, graphics and printed components.
High attention to detail and demonstrated ability to manage multiple critical path projects concurrently
Ability to develop, implement and monitor a metrics performance package for labeling and packaging activities.
General knowledge of GMP and/or GCP
Demonstrated understanding of quality management and documentation systems – especially as related to change control process and product specifications
Demonstrates flexibility through adapting to external environment influences through development of new strategies and tactics
Excellent communication and influencing skills, strong collaboration skills
Ability to multi-task and manage complexity
Positive attitude and strong interpersonal skills required to effectively address problems and interface with other functional areas of the company while working in a matrixed global environment.
Education & Experience Requirements
Bachelors in life sciences, package engineering, graphic design, or business major required and 12+ years of experience or a master’s with 9+ years of experience
5+ years work experience in pharmaceuticals is preferred
Proficient knowledge of Microsoft Suite of software required
Additional knowledge of electronic label management, CAPA, specification, and change control and project management systems preferred
Physical Demands and Work Environment
Travel domestic and international – up to 10%
In-house position based in Waltham, MA. Considerations for hybrid remote work available.
For more information about Alkermes or to apply to a position, please visit our website at www.alkermes.com and search our Careers page.
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.
Experience Level:
Mid-Senior Level
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Sep 23rd, 2021 12:06AM
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Sep 23rd, 2021 12:06AM
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Alkermes
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Health Care
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Pharmaceuticals & Biotechnology
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nasdaq:alks
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www.alkermes.com
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www.alkermes.com
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Sep 23rd, 2021 12:00AM
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Associate Director, Clinical Programming
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Open
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11150
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New Search
Login Page
Position Description
Associate Director, Clinical Programming
Job ID
11150
Location
Waltham, MA
Field Locations
Apply Now
Alkermes, Inc. is the U.S. operating company of Alkermes plc, a fully integrated, global biopharmaceutical company that applies its scientific expertise and proprietary technologies to research, develop and commercialize, both with partners and on its own, pharmaceutical products that are designed to address unmet medical needs of patients in major therapeutic areas. Alkermes has a diversified portfolio of marketed products focused on central nervous system disorders such as addiction and schizophrenia and a pipeline of product candidates in the fields of neuroscience and oncology. Headquartered in Dublin, Ireland, Alkermes has a research and development (“R&D”) center in Waltham, Massachusetts; an R&D and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio.
The following position is for Alkermes, Inc.
POSITION SUMMARY:
Responsible for the Clinical Programming leadership, delivery and quality efforts in support of Clinical Data Sciences activities within the Clinical Development Operations organization.
Duties and Responsibilities:
• Leadership responsibilities for internal clinical programming and ad-hoc requests for Alkermes clinical programs from database start-up through database lock and CSR/submission.
• Manages clinical vendors and programming relationships specific to clinical programming/data review outputs, metrics and dashboards, data cleaning, ad-hoc reporting, data review, data surveillance and data mining via strategic partnerships with preferred vendors.
• Oversight of programming specifications, templates and documentation in accordance with ICH/GCP guidelines and current regulatory requirements.
• Provides support and consultation to Data Management in review of key documents such as data validation specifications and listing programs, User Acceptance Testing, manual data review guidelines, computerized edit check programs, Data Management Plans (DMP), etc.
• Provides ad-hoc programming support to Clinical Operations, Data Management, Statistical Programming, Biostatistics, Drug Safety, Clinical Science, Medical Writing and Drug Safety to ensure rapid access to clinical study data or data cleaning/validation, safety signaling, clinical data review, etc., for internal clinical data review.
• Develops and implements clinical programming request tracking mechanisms. Tracks, analyzes, and reports on internal programming requests and clinical programming key performance indicators, metrics, and program level deliverables and timelines.
• Drives, supports and maintains appropriate Data Visualization tools providing information about data quality, study metrics, etc.
• Liaises with Technical Solutions group on initiatives including system integration, data transfer and sharing, access and storage. Leads and/or supports other initiatives to support Process or Technological Improvement, such as Clinical Data Review, Risk Based Monitoring, Data Standards, Coding and Lab review.
• Assists in development and maintenance of Clinical Standards templates including eCRFs, edit checks, table shells, clinical data archiving, etc.
• Collaborate with Clinical Data Analytics team to support a Clinical Data Lake environment.
• Contribute in all aspects of data strategy, analytics, visualization and adoption of a “Data Culture” within the organization.
Qualifications:
• Science and/or Computer Systems/IT background, Bachelor’s or healthcare degree (i.e., Science, Programming or Technical discipline)
• Minimum 8-10 years (3-5 years supervisory/leadership) experience in a pharmaceutical/biotech setting preferred
• Advanced programming and analytical skills using BASE/SAS, SAS/STAT, SAS MACROS
• Advanced technical expertise in databases development, EDC experience in one or more of the following systems (OmniComm, TrialMaster, Medidata RAVE, Oracle Clinical, InForm, ClinTrial); data imports/integrations; SAS and/or SQL
• Knowledge and use of data visualization or data review tools (D3.js, Spotfire, Tableau).
• Programming\analytical skills using R and Python a plus.
• Excellent project management skills, CRO oversight skills, professional attitude, self-improvement mentality with positive attitude
• Demonstrated written and oral presentation skills and ability to communicate effectively to other programmers and non-technical colleagues
• Ability to think creatively and independently, and to form sound opinions and make sensible decisions in a dynamic environment
• Advanced knowledge of GCP/ICH standards, 21 CFR Part 11, CDISC requirements
• Proven ability to work effectively both independently or in a team setting, and to meet set goals by managing own timelines.
• Experience in leading cross-functional, multicultural and international clinical programming efforts/ teams.
Physical Demands and Work Environment:
• Travel domestic and international – up to 15%
• In-house position based in Waltham, MA
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.
#LI-PM1
Experience Level:
Mid-Senior Level
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Apply Now
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Sep 23rd, 2021 12:06AM
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Sep 23rd, 2021 12:06AM
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Alkermes
|
Health Care
|
Pharmaceuticals & Biotechnology
|