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Senior Medical Director, Drug Safety and Pharmacovigilance

1 month ago

Waltham, Massachusetts, United States Alkermes, Inc. Full time
Job Overview

The Senior Medical Director/Global Safety Officer will provide strategic safety oversight for assigned investigational and/or marketed products within the Alkermes Neuroscience portfolio. This role will work closely with the DSPV leadership team and serve as a visible resource for safety advisement in company-wide forums and initiatives.

The ideal candidate will have prior career success as a product safety physician, having led clinical and post-marketing programs as the Safety lead. They will be responsible for collaborating with cross-functional teams, keeping the DSPV leadership informed of evolving safety issues and strategies, and building high trust and accountability.

This is a hybrid, weekly onsite position based in our Waltham, MA office. The Senior Medical Director/Global Safety Officer will report to the VP, Drug Safety & Pharmacovigilance (DSPV).

Responsibilities and Duties
  • Provide medical leadership within Drug Safety Benefit-Risk Management
    • Accountable for therapeutic area/product safety oversight and strategies/activities including (but not limited to):
      • Strategic advisement on clinical development plans, design of clinical protocols.
      • Responsible for safety content of IB and ICFs and support of DSMBs or Study specific safety review forums for clinical programs.
      • Strategic safety input for Regulatory documents and benefit-risk content within the Clinical Overview documents, Briefing Books, INDs, Annual reports, labeling etc.
      • Responsible for the content of any Risk Management Plan, and for the overall risk management and minimization strategies for assigned programs/portfolio, in alignment with internal stakeholders.
      • Responsible for the content of aggregate safety reports (i.e., DSUR, PSUR, PADER) including assessment of benefit-risk evaluation.
      • Advisement on the design of post-approval safety studies; Safety SME and contributor for publications, HEOR and epidemiology projects.
      • Be a resource and the safety expert to DSPV, cross-functional teams and leadership, on matters of safety findings, quality issues, safety regulations and processes, industry standards, and other relevant topics relating to safety input.
  • Medical and Safety expertise towards Business Development/Due Diligence activities for Alkermes Neuroscience portfolio.
  • Senior Medical Director/Global Safety Officer for assigned investigational and/or marketed products will:
    • 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.

Basic Requirements:

  • MD, or MD PhD, or MD MPH required.
  • Minimum 10-12 years' experience in Drug Safety & Pharmacovigilance and/or comparable relevant clinical experience.

Preferred Requirements:

  • Prior experience in patient care, clinical development (including early clinical), and/or knowledge of clinical pharmacology desirable.
  • Safety/medical experience in the Neuroscience therapeutic space is highly desirable.
  • Strategic and critical thinking skills.
  • 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.
  • Sense of urgency and accountability for both individual and team-owned work products.
  • Knowledge of pre- and post-marketing US and EU regulations.