Executive Medical Director, DSPV

Role Summary

The Executive Medical Director is a senior member of the DSPV leadership team responsible for the management, mentoring and development of benefit-risk management staff and serving as a global safety officer for assigned investigational and/or marketed products. Reporting to the Head of DSPV, this role provides safety leadership and advisement in company-wide forums and initiatives. The candidate should have a track record as a product safety physician with experience building and leading effective teams, and must be willing to contribute hands-on work while developing direct reports. This position operates in a hybrid environment (60% in-office, 40% remote) and is based at the Waltham, MA office (onsite at least 3 days per week).

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
• Provide strategic safety leadership and oversight for assigned programs across the product lifecycle:
• 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

• Responsibilities include: advisement, employee development, design and implementation of department goals, policies and long-term strategies

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