Executive Medical Director, SERM

Sarepta Therapeutics•Cambridge, MA

2d•Hybrid

About The Position

The Executive Medical Director, SERM will provide leadership for safety scientists and/or safety physicians in the SERM group. This individual will be accountable for safety, pharmacovigilance, and risk management activities for assigned investigational and marketed products. The Executive Medical Director, SERM will function in a company matrix team environment interacting with several key stakeholder groups including Nonclinical, Research, Clinical Development, Clinical Operations, Biometrics, Medical Affairs, Regulatory Affairs, Quality Assurance, and Commercial.

Requirements

M.D. with solid knowledge and clinical practice experience of General Medicine.
Experience in medical safety activities within PV for products in clinical trials and in post marketing is required.
7+ years pharmacovigilance experience.
Competent in safety reviews of clinical safety data/documents including AEs/SAEs, IBs, protocols, clinical study reports and informed consent documents and safety submissions (CTD clinical safety summary).
Competent in safety reviews of postmarketing safety documents including spontaneous reports and other individual case safety reports (ICSRs), periodic safety reports, risk management plans, company core data sheet
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 identification and communication of relevant safety-related issues or concerns to PV & RM Management in an appropriate and timely manner.
Ability to multi-task.
Close attention to detail
Candidates must be authorized to work in the U.S.

Responsibilities

Represents PV & RM in clinical development projects providing expert medical guidance on safety matters for investigational products.
Responsible for communicating or producing safety alerts/signals, development risk management plans, reference safety information and safety evaluations of emergent safety issues.
Provides medical safety oversight in clinical trials.
Participates in protocol development, specifically the collection and monitoring of safety data in interventional and observational studies, medical review of adverse events/SAEs and evaluation of safety data and statistical analysis planning and reporting of study data.
Contributes to preparation and review of periodic safety reports (DSUR, EAP Reports)
Contributes to activities of DSMBs and safety events adjudication committees.
Contributes to analysis of safety data from on-going and completed studies and their representation in clinical study reports.
Provides leadership for IB section “Guidance for Investigators” and other safety sections.
Provides leadership on clinical safety content of country marketing applications e.g. NDA/MAA Clinical Safety Summary and REMS/Risk Management Plan.
Performs medical review oversight for individual case safety reports (ICSRs) from post-marketing sources.
Leads product risk management strategy and facilitates production and maintenance of risk management plans.
Participates in the signal management system with regular review of safety data for assigned products and detection and evaluation of new safety signals.
Provides medical input to design and maintenance of REMS programs, monitoring of REMS goals and provision of REMS Assessment Reports.
Leads benefit-risk discussions at the safety governance committee and implementation of risk minimization actions.
Conducts medical evaluation of relevant safety-related information from toxicology, non-clinical studies, as well as product quality complaints, as needed.
Contributes to preparation and review of periodic safety reports (FDA Enhanced PV Plan Report, PBRER).
Provides leadership for the safety physicians and safety scientists in the SERM group.
Participates in leadership oversight of safety vendors and provides back-up for the Head of PV & RM.
Participates in continuous improvement activities of self as well as for PV & RM department including systems design and quality management activities.
Contributes to development of the PV & RM department via involvement in recruiting/coaching talent and fiscal management.