Sr. Medical Director/Medical Director, Global Safety Officer

Role Summary

The Sr. Medical Director/Medical Director, Global Safety Officer (GSO) will provide strategic safety oversight for the assigned investigational and/or marketed products within the Alkermes Neuroscience portfolio. They will work closely with the DSPV leadership team, serve in a visible safety advisory role across company-wide forums, and collaborate with cross-functional partners to keep leadership informed of evolving safety issues and strategies. The role requires a product safety physician with a track record of leading clinical and post-marketing programs, strong stakeholder engagement, and the ability to manage critical projects with urgency—either independently or in a team setting.

Responsibilities

• Provide medical leadership within Drug Safety Benefit-Risk Management.
• Accountable for therapeutic area/product safety oversight and strategies, including:
  • Strategic advisement on clinical development plans and protocol design.
  • Safety content of Investigator’s Brochure (IB) and Informed Consent Forms (ICFs) and support of DSMBs or safety review forums.
  • Strategic safety input for regulatory documents and benefit-risk content within Clinical Overview, Briefing Books, INDs, annual reports, labeling, etc.
  • Content and oversight of Risk Management Plans and overall risk minimization strategies.
  • Content of aggregate safety reports (DSUR, PSUR, PADER) with benefit-risk assessment.
  • Advisement on post-approval safety studies; Safety SME and contributor for publications, HEOR, and epidemiology projects.
  • Serve as a safety expert to DSPV and leadership on safety findings, quality issues, regulations, processes, and industry standards.
• Contribute Medical and Safety expertise to Business Development/Due Diligence for Alkermes Neuroscience portfolio.
• Lead safety oversight for assigned investigational and/or marketed products, including:
  • Lead product safety surveillance and signaling activities with DSPV staff.
  • Develop deep understanding of disease processes and product safety/efficacy profiles; stay informed on class therapies.
  • Ensure routine signaling activities, assessments, and investigations are completed timely.
  • Communicate and respond to product safety queries from ethics committees and regulatory authorities.
• Lead product benefit-risk assessment and presentation to Safety Committee; drive actions to update patient safety information.
• Represent Drug Safety and Pharmacovigilance in program and study teams.

Qualifications

• Required: MD or MD/PhD.
• Required: Minimum of 4+ years of experience for the Medical Director role; 7+ years for the Sr. Medical Director role in Drug Safety & Pharmacovigilance and/or related clinical experience.

Preferred

• Prior experience in patient care, clinical development (including early clinical), and/or knowledge of clinical pharmacology.
• Safety/medical experience in the Neuroscience therapeutic space.
• Strategic and critical thinking skills.
• Leadership and ability to operate effectively in a matrixed, dynamic environment across functions and geographies; entrepreneurial mindset.
• Excellent communication (oral and written) and organizational skills.
• Sense of urgency and accountability for individual and team work products.
• Knowledge of pre- and post-marketing US and EU regulations.

Additional Requirements

• Sr. Medical Director level requires demonstrated ability to lead safety strategy across global clinical programs and post-marketing settings; experience representing DSPV in regulatory inspections and cross-functional governance forums; advanced understanding of global pharmacovigilance regulations and benefit-risk frameworks; experience contributing to scientific publications and external presentations on safety topics.
• Hybrid work arrangement: 60% in office, 40% from home; onsite at Waltham, MA at least 3 days per week; not eligible for fully remote.