Senior Director, Medical Safety Science
About The Position
Opportunity awaits those up to the challenge of developing transformative therapies across a broad range of debilitating diseases. Summary: Apellis Safety & Benefit-Risk (SaBR) is responsible for all aspects of patient safety, including single case and aggregate safety monitoring, safety reporting, benefit-risk assessment, risk management planning and strategy, execution of certain post-marketing commitments, and compliance with global regulatory requirements. Reporting to the Head of SaBR, the Executive Director, Medical Safety Science serves as a senior leader accountable for the strategic direction, operational excellence, and organizational leadership of the Medical Safety Science (MSS) function. This individual will lead a team of Safety Physicians and PV Scientists and serve as a key decision-maker across the company’s pipeline and marketed products. The ideal candidate brings deep clinical knowledge, broad pharmacovigilance expertise, and strong executive presence, and will play a critical role in shaping the company’s safety strategy at the highest levels, global regulatory interactions, portfolio governance, and long-term planning.
Requirements
- MD/DO/Equivalent required; specialty training or board certification preferred
- 12+ years of progressive experience in drug safety and pharmacovigilance, including both clinical development and post-marketing surveillance.
- 5+ years in a senior leadership or executive role within a global pharmaceutical or biotechnology environment.
- Proven experience in leading high-impact global safety teams and shaping portfolio-wide safety strategies.
- Demonstrated success in regulatory interactions, product labeling negotiations, and cross-functional leadership at the executive level.
- Strong understanding of global PV regulations, benefit-risk assessment methodologies, and regulatory trends.
- Executive-level communication and influencing skills; proven ability to operate effectively with executive teams and external stakeholders.
Nice To Haves
- An MPH or equivalent training in epidemiology is preferred
- Therapeutic experience in nephrology or ophthalmology preferred.
Responsibilities
- Enterprise Safety Leadership Define and execute the vision, strategy, and roadmap for MSS across all therapeutic areas and lifecycle stages.
- Serve as the MSS expert and advisor to R&D, Regulatory, Medical Affairs, Commercial, Legal, and senior leadership.
- Chair internal safety governance forums and represent Apellis in external stakeholder meetings, regulatory interactions, and industry collaborations.
- Strategic Portfolio Oversight Oversee benefit-risk strategies and signal management activities across the global portfolio, including early development, pivotal studies, post-marketing, and real-world evidence.
- Ensure effective integration of safety insights into clinical development plans, regulatory submissions, labeling, and life-cycle management decisions.
- Regulatory Strategy and Inspection Readiness Provide global safety input to the Head of SaBR during interactions with health authorities, including FDA, EMA, and PMDA.
- Serve as a company representative in regulatory negotiations and safety-related inspections.
- Ensure all MSS deliverables meet regulatory standards and support Apellis’ reputation for excellence and compliance.
- Organizational Leadership & Development Build, mentor, and lead a high-performing organization, including physicians, PV scientists, and cross-functional collaborators.
- Drive talent development, succession planning, and organizational design to support future growth and complexity.
- Champion a culture of scientific rigor, cross-functional collaboration, accountability, and innovation.
- Operational Excellence & Innovation Oversee the development and execution of safety processes, standards, and technologies to improve efficiency, scalability, and scientific quality.
- Advance the use of digital tools, AI, and predictive analytics in signal detection and benefit-risk management.
- Business Development & Growth Strategy Provide MSS input into due diligence and risk assessment in partnership with Business Development, Corporate Strategy, and Legal.
- Play a key role in integrating safety strategy into M&A, licensing, and external partnerships.
Benefits
- Apellis offers a comprehensive benefits package, including a 401(k) plan with company match, inclusive family building benefits, flexible time off, summer and winter shutdowns, paid family leave, disability and life insurance, and more!
- Visit https://apellis.com/careers/benefits/ to learn more.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
