The Senior Medical Director serves as the global safety officer for the pharmacovigilance and risk management of assigned investigational and/or marketed products with a primary focus in neuroscience products. Responsible for identification of safety signals, signal investigation and the proactive management of the benefit-risk profile for assigned products. The global safety officer 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. Responsible for collaborating and working effectively with key stakeholders and business partners and keeping senior management informed of evolving safety issues and strategies. May represent Alkermes at internal and external meetings.
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. 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.
Position will report to the Head of Drug Safety and Pharmacovigilance.
- Lead product safety surveillance, and signaling activities for assigned product(s) 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.
- If applicable, manage Medical Director(s) and/or Associate Medical Director(s), overseeing their activities for assigned compounds / products.
- Other job duties that may be assigned according to business needs.
- MD, or MD PhD, or MD MPH required
- Minimum of 7-years of experience in drug safety.
- Strong background in drug safety for neurosciences products
- 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
- Demonstrated sense of urgency and accountability for both individual and team-owned work products.
- Knowledge of pre- and post-marketing US and EU regulations
- 7-years of experience in drug safety.
- Excellent communication (oral and written) as well as organizational skills.
- High EQ with a passion for drug safety and collaboration within the department and across functions