Senior Medical Director, Global Safety

Opportunity Overview

Rhythm is seeking a Senior Medical Director, Global Safety, to provide medical leadership and expertise across the safety of our products throughout development and commercialization. This individual will serve as a key medical safety expert and leader within the Global Safety organization, providing oversight and direction to safety physicians supporting Rhythm's portfolio. The Senior Director will lead safety surveillance, signal evaluation, and ongoing benefit-risk assessment while partnering closely with Clinical Development, Regulatory Affairs, Biostatistics, Medical Affairs, and external partners.

Responsibilities and Duties

• Provide strategic medical safety leadership and oversight across Rhythm products and programs, including direction and oversight of safety physicians supporting the portfolio.
• Serve as the primary safety physician and medical subject matter expert for assigned Rhythm products, maintaining a comprehensive understanding of their evolving safety profiles.
• Lead safety surveillance, signal evaluation, and ongoing benefit-risk assessment activities, providing expert medical judgment on complex or emerging safety issues.
• Collaborate cross-functionally with Clinical Development, Regulatory Affairs, Biostatistics, Medical Affairs, and other functions to integrate safety considerations into clinical development, regulatory strategy, and risk mitigation approaches.
• Identify, evaluate, and communicate potential safety concerns, ensuring timely escalation of significant safety findings to Global Safety leadership and relevant governance committees.
• Provide medical oversight for global PV processes and activities, working with internal functions, CROs, and PV vendors to ensure high-quality and compliant execution.
• Provide medical safety leadership on the development and review of clinical protocols, investigator's brochures, informed consent forms, safety management plans, aggregate safety reports, health authorities' responses and other clinical, regulatory, and safety documents.
• Prepare for and participate in health authority interactions and provide medical safety expertise during regulatory inspections and audits.
• Contribute to the development, review and implementation of SOPs, Work Instructions, guidelines, and other tools pertaining to safety practices.
• Lead, manage, and develop safety physicians and scientists, providing clear direction, coaching, and oversight while building medical safety capabilities and ways of working as the organization grows.

Qualifications and Skills

• M.D. degree or equivalent required.
• Completion of postgraduate clinical training or residency preferred.
• At least 10 years of progressively responsible experience in pharmacovigilance/drug safety within the pharmaceutical or biotechnology industry, including significant experience providing medical safety leadership for clinical development programs and/or marketed products.
• Demonstrated experience leading medical safety teams and cross-functional safety activities or programs; people management experience strongly preferred.
• Strong understanding of global pharmacovigilance regulations and guidance, including FDA, EMA, ICH, and other regional requirements.
• Demonstrated experience leading safety surveillance, signal detection, benefit-risk assessment, risk management, and aggregate reporting activities for investigational and/or marketed products.
• Familiarity with drug safety databases (previous experience with Argus is a plus), data analysis tools, and document management systems.
• Excellent oral and written communication skills with the ability to clearly communicate complex safety information to a range of internal and external stakeholders.
• Strong collaboration and interpersonal skills with the ability to influence effectively across functions and with external partners.
• Ability to manage and prioritize multiple projects and demands simultaneously; rapidly adjust to changing priorities and work effectively under pressure.
• Strong commitment to scientific rigor, quality, compliance, and operational excellence.
• Self-motivated and adaptable, with the ability to identify core challenges and adjust direction as priorities evolve in a fast-paced organization.
• High degree of professional ethics, integrity, and judgment.