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.
The Medical Director serves as the therapeutic area lead for all assigned investigational and/or marketed products in pharmacovigilance and risk management activities. This may also include serving as a global safety officer for one or more assigned investigational and/or marketed products. The candidate will have a visible role in providing safety leadership and advisement in several company-wide forums and initiatives.
The successful candidate must have demonstrated prior success as a product safety physician or similar role. . He/she will have a high EQ with a passion for Drug Safety and managing/developing individuals and highly effective teams. Key success factors include building high trust, accountability and demonstrating a sense of urgency in leading critical projects, showing the capability to work either independently or collaboratively and to be able to effectively communicate with varied stakeholders both verbally and in writing. The individual who assumes this position will interact with multiple levels of management within Alkermes, external stakeholders in the medical community as well with global regulatory authorities. Overseeing safety scientists who are responsible for identification of safety signals, signal investigation and the proactive management of the benefit-risk profile for assigned products, the role plays a critical leadership role in to program team through the product life-cycle working in close collaboration with Research, Pre-clinical Safety, Clinical Development, Medical Affairs, Regulatory Affairs and other functions in product life-cycle management.
The successful candidate will have demonstrated accountability and a sense of urgency in leading critical projects, showing the capability to work either independently or collaboratively and to be able to effectively communicate with varied stakeholders either verbally or in writing with impact.
Position will report to the Executive/Senior Medical Director, Drug Safety and Pharmacovigilance.
- Lead/oversee product safety strategy, surveillance, and signaling activities in collaboration with DSPV staff
- Acquire a deep understanding of the disease process and assigned product(s) efficacy and safety profile including a working knowledge of other products in the class and therapeutic space
- Ensure that routine signaling activities, assessment and investigation are completed and documented in a timely manner
- Responses to product safety queries from all sources including ethics committees and regulatory authorities
- Lead product benefit-risk assessment and presentation to the Safety Committee and any needed actions to update patient safety information
- Lead Drug Safety and Pharmacovigilance representation in the assigned program team and clinical development team and respective study management teams with critical roles which include:
- Strategic advisement on clinical development plans, design of clinical protocols
- Responsible for safety content of IB and ICFs and support of DSMBs
- Analysis strategy for Integrated Summary of Safety (ISS) and benefit-risk content within the Clinical Overview documents associated with regulatory filings
- Responsible for the content of Risk Management Plan/ REMS as required
- Responsible for content of aggregate safety reports (i.e., DSUR, PSUR) including assessment of benefit-risk
- Advisement on the design of post-approval safety studies
It is expected that the global safety officer will establish a high level of trust and collaboration with cross-functional counterparts in carrying out these activities:
- Ensure development and implementation of other department goals, policies and strategies in collaboration with the DSPV management team, consistent with regulatory requirements and industry best practices.
- Ensure the accurate and timely completion and reporting of periodic and expedited safety reports, in compliance with internal timeframes and timeframes dictated by regulatory authorities.
- Other job duties that may be assigned according to business needs.
- MD, or MD PhD, or MD MPH required
- Minimum of 5-years of industry experience; experience in drug safety highly preferred
- Experience in oncology and/or neuroscience preferred
- High EQ with a passion for Drug Safety Prior experience in patient care, clinical development and/or knowledge of clinical pharmacology desirable.
- Demonstrated strategic and critical thinking skills.
- Demonstrated leadership as well as the ability to perform effectively in a matrixed and dynamic environment, ability to lead and collaborate within complex organization, across functions and geographies; to work in an entrepreneurial culture
- Excellent communication (oral and written) as well as organizational skills.
- Demonstrated sense of urgency and accountability for both individual and team-owned work products.
- Knowledge of pre- and post-marketing US and EU regulations
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.