Executive Medical Director, DSPV na Commercial
Commercial · Waltham, Estados Unidos Da América · Hybrid
- Senior
- Escritório em Waltham
The Executive Medical Director serves as a senior member of the DSPV leadership team, accountable for the management, mentoring and development of assigned benefit-risk management staff as well as serving as a global safety officer for assigned investigational and/or marketed products. Reporting to the Head of DSPV, the Executive Director will also serve in a visible role in providing safety leadership and advisement in several company-wide forums and initiatives.
The successful candidate will have demonstrated prior career success as a product safety physician and managing/ developing individuals and highly effective teams. This leader will be expected to roll-up their sleeves and help do the work in addition to managing direct reports. Key success factors also 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.
Responsibilities
- Provide medical leadership and management/development to direct reports within Drug Safety Benefit-Risk Management
- Accountable for therapeutic area/product safety oversight and strategies/activities performed by direct reports including:
- 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
- Accountable for therapeutic area/product safety oversight and strategies/activities performed by direct reports including:
- In role as a Global Safety Officer for assigned investigational and/or marketed products:
- 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
- Ability to effectively communicate and respond 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:
- Lead product safety surveillance, and signaling activities for assigned product(s) in collaboration with DSPV staff
- Senior member of the Drug Safety leadership team:
- Responsibilities include: advisement, employee development, design and implementation of department goals, policies and long-term strategies
- Senior medical leadership representative from Drug Safety with highly visible role in protocol review committees and other company-wide forums and initiatives
Qualifications
- MD, or MD PhD, or MD MPH required
- Minimum of 10+ years of experience in drug safety
- Prior experience in patient care, clinical development and/or knowledge of clinical pharmacology desirable
- High emotional intelligence with experience managing and developing direct reports as well as highly effective teams
- 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 has recently adopted a hybrid working environment to support and meet the needs of employees and this role will operate in a flexible environment with 60% of time in the office and 40% from home. This position is eligible for the hybrid workplace model, requiring work to be completed onsite at our Waltham, MA office at least 3 days per week. This role is not eligible for fully remote.
The annual base salary for this position ranges from $338,500 to $365,000. In addition, this position is eligible for an annual performance pay bonus. Exact compensation may vary based on skills, training, knowledge, and experience. Alkermes offers a competitive benefits package. Additional details can be found on our careers website: www.alkermes.com/careers#working-here
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