Sr. Medical Director/Medical Director, Global Safety Officer

Role Summary

The Sr. Medical Director/Medical Director, Global Safety Officer (GSO) provides strategic safety oversight for the Alkermes Neuroscience portfolio, collaborating with DSPV leadership and cross-functional teams. Reports to the Head of DSPV and serves in a visible role advising on safety issues and strategies across company forums and initiatives. Role requires proven product safety leadership, able to work independently or with teams, and to communicate effectively with diverse stakeholders. Hybrid work arrangement: 60% in office, 40% from home, onsite at the Waltham, MA office at least 3 days per week.

Responsibilities

• 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
• Safety content of IB and ICFs and support of DSMBs or study-specific safety review forums
• Strategic safety input for regulatory documents and benefit-risk content within Clinical Overview documents, Briefing Books, INDs, Annual reports, labeling, etc.
• Content of Risk Management Plans and overall risk management/minimization strategies for assigned programs/portfolio
• Content of aggregate safety reports (DSUR, PSUR, PADER) including benefit-risk assessment
• Advisement on post-approval safety studies; safety SME and contributor for publications, HEOR and epidemiology projects
• Be a safety expert to DSPV, cross-functional teams and leadership on safety findings, quality issues, regulations, processes, and industry standards
• Medical and Safety expertise towards Business Development/Due Diligence for Alkermes Neuroscience portfolio
• The Global Safety Officer will lead safety oversight for assigned investigational and/or marketed products, including:
• Lead product safety surveillance and signaling activities with DSPV staff
• Acquire deep understanding of disease process and product efficacy/safety profile; knowledge of class and therapeutic space
• Ensure routine signaling activities, assessment, and investigation are completed and documented timely
• Communicate and respond to product safety queries from ethics committees and regulatory authorities
• Lead product benefit-risk assessment and presentation to Safety Committee and required actions to update patient safety information
• Lead Drug Safety and Pharmacovigilance representation in program and study management teams

Qualifications

• MD or MD/PhD required
• Minimum of 4+ years of experience required for the Medical Director role, or 7+ years for the Sr. Medical Director role in Drug Safety & Pharmacovigilance and/or other relevant clinical experience
• Preferred: Prior experience in patient care, clinical development (including early clinical), and/or knowledge of clinical pharmacology
• Preferred: Safety/medical experience in the Neuroscience therapeutic space
• Preferred: Strategic and critical thinking skills
• Preferred: Leadership in a matrixed, dynamic environment with cross-functional and geographic collaboration
• Preferred: Excellent communication (oral and written) and organizational skills
• Preferred: Sense of urgency and accountability for individual and team work products
• Preferred: Knowledge of pre- and post-marketing US and EU regulations

Additional Requirements

• 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