Executive Medical Director, DSPV

Role Summary

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, with a focus on high trust, accountability and urgency in leading critical projects, and effective communication with diverse stakeholders.

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
• 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

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