Senior Director, DSPV Medical Safety

Role Summary

Senior Director, DSPV Medical Safety is the medical expert for assigned products, maintaining current knowledge of the product portfolio and safety profiles. The role provides day-to-day direction to the Medical Safety Team to ensure priority tasks are completed on time and in compliance with company and regulatory policies and procedures. Globally, this role implements safety and risk management activities for clinical development, oversees safety surveillance, risk management, and risk communication for assigned development products, and reviews safety data and safety documents, including labeling changes.

Responsibilities

• Review safety data from various sources (e.g., pre-clinical, clinical trial data, post-marketing, literature) throughout the development process for assigned products and development compounds.
• Deliver high quality medical safety deliverables and obtain content and functional approval for safety documentation in collaboration with the Executive Safety Committee.
• Conduct safety signal detection, monitoring, evaluation, interpretation, and management/communication of safety information.
• Lead Safety Review Teams for assigned products and development compounds; assess benefit-risk profiles and draft/update benefit-risk documents.
• Provide medical expert safety input into critical clinical development documents (protocols, amendments, ICFs, IBs, IMPDs, reports, INDs, CTAs).
• Collaborate with the Executive Director of DSPV to develop strategy and implementation of safety and benefit-risk management for assigned products.
• Identify risks and implement risk minimization and pharmacovigilance measures in compliance with regulatory requirements; contribute to Benefit-Risk Assessments, CSDS, Investigator’s Brochure, RMPs, REMS.
• Prepare responses to regulatory inquiries on safety issues and lead integrated safety input into regulatory documents.
• Maintain and evaluate Medical Safety metrics and quality plans, including metric reporting, issue identification, action planning, and communication of metrics.
• Oversee pharmacovigilance activities with external partners or CROs.

Qualifications

• Required: MD or DO with 8+ years of pharmaceutical industry experience in Drug Safety/Pharmacovigilance, working with investigational and marketed products.
• Required: 5+ years of experience with medical case reviews, aggregate reporting, safety surveillance, signal management, and/or risk management.
• Required: Global Pharmacovigilance experience with strong knowledge of global PV regulations and ICH guidelines.
• Required: Ability to review and prepare scientific/regulatory documents from large volumes of information.
• Required: Experience presenting drug safety topics and data to regulatory authorities or health authorities.
• Required: Experience in drug development and clinical trial methodology; leadership roles in clinical or safety through the submission process.
• Required: Strong leadership, mentoring, collaboration across cross-functional teams, and excellent verbal/written communication skills.
• Required: Ability to build and maintain effective working relationships with subordinates, superiors, and peers.

Preferred Qualifications

• Master of Public Health (MPH) in addition to MD or DO.
• 2+ years of Clinical Patient Care experience.
• Experience providing product defense before national or international regulatory authorities.
• Experience in the rare disease arena.
• Drug safety database knowledge.

Education

• MD or DO (required); additional public health training (e.g., MPH) preferred.

Additional Requirements

• Location: Fully remote possible; occasional travel for team meetings or events (approximately 10% travel).