Executive Medical Director, SERM

Sarepta Therapeutics • Cambridge, MA

1d • $313,200 - $391,500 • Hybrid

About The Position

The Executive Medical Director, SERM provides leadership for safety scientists and/or safety physicians in the SERM group and is accountable for safety, pharmacovigilance, and risk management activities for assigned investigational and marketed products. The role works in a company matrix environment with stakeholders across Nonclinical, Research, Clinical Development, Clinical Operations, Biometrics, Medical Affairs, Regulatory Affairs, Quality Assurance, and Commercial.

The position represents Pharmacovigilance and Risk Management in clinical development, providing expert medical guidance on product safety and oversight of clinical-trial safety. It leads product risk-management strategy, signal detection and evaluation, benefit-risk discussions, and risk-minimization activities, while contributing to safety documents and regulatory submissions for investigational and marketed products.

The role also provides leadership to SERM safety physicians and scientists, participates in oversight of safety vendors, and backs up the Head of PV & RM. It contributes to departmental continuous improvement, recruiting and coaching, and fiscal management. This is a hybrid position requiring on-site work at a Sarepta facility in the United States and/or attendance at company-sponsored in-person events from time to time. Candidates must be authorized to work in the U.S.

Requirements

• M.D. with solid knowledge and clinical practice experience in General Medicine.
• Experience in medical safety activities within pharmacovigilance for products in clinical trials and in post-marketing settings.
• At least 7 years of pharmacovigilance experience.
• Competence in reviewing clinical safety data and documents, including adverse events and serious adverse events, Investigator Brochures, protocols, clinical study reports, informed consent documents, and safety submissions such as CTD Clinical Safety Summaries.
• Competence in reviewing post-marketing safety documents, including spontaneous reports and other individual case safety reports, periodic safety reports, risk-management plans, and company core data sheets.
• Knowledge of GVP, GCP, ICH guidance, and safety regulations.
• Ability to communicate and collaborate effectively in a matrix environment.
• Excellent written and oral communication skills.
• Good judgment and decision-making skills, including identifying and communicating relevant safety issues or concerns to PV & RM management appropriately and promptly.
• Ability to multitask.
• Close attention to detail.
• Must be authorized to work in the United States.

Responsibilities

• Represent Pharmacovigilance and Risk Management in clinical development projects and provide expert medical guidance on safety matters for investigational products.
• Communicate or produce safety alerts and signals, development risk-management plans, reference safety information, and evaluations of emergent safety issues.
• Provide medical safety oversight in clinical trials, including protocol development, safety-data collection and monitoring, medical review of adverse events and serious adverse events, and evaluation of safety data and statistical analysis planning and reporting.
• Contribute to preparation and review of periodic safety reports, including DSURs, EAP Reports, FDA Enhanced PV Plan Reports, and PBRERs.
• Contribute to the work of Data and Safety Monitoring Boards and safety-event adjudication committees.
• Analyze safety data from ongoing and completed studies and contribute to its presentation in clinical study reports.
• Lead the Investigator Guidance section of Investigator Brochures and other safety sections.
• Lead clinical-safety content for country marketing applications, including NDA/MAA Clinical Safety Summaries and REMS/Risk Management Plans.
• Oversee medical review of individual case safety reports from post-marketing sources.
• Lead product risk-management strategy and facilitate the creation and maintenance of risk-management plans.
• Participate in signal management through regular safety-data review and detection and evaluation of new safety signals for assigned products.
• Provide medical input into the design and maintenance of REMS programs, monitoring of REMS goals, and preparation of REMS Assessment Reports.
• Lead benefit-risk discussions at the safety governance committee and implementation of risk-minimization actions.
• Evaluate relevant safety information from toxicology and nonclinical studies, as well as product-quality complaints, as needed.
• Provide leadership for safety physicians and safety scientists in the SERM group.
• Participate in leadership oversight of safety vendors and provide backup for the Head of PV & RM.
• Participate in continuous improvement for self and the PV & RM department, including systems design and quality-management activities.
• Contribute to PV & RM department development through recruiting and coaching talent and fiscal management.

Benefits

• Competitive compensation and benefit package.
• Benefits and work-life resources supporting physical and emotional wellness, financial wellness, and caregivers.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree