Vice President, Medical Safety Science

Position Summary:

Apellis Drug Safety and Pharmacovigilance 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 Drug Safety and Pharmacovigilance, the Vice President, Medical Safety Science serves as a senior leader accountable for the strategic direction, operational excellence, and organizational leadership of the Medical Safety Science 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.

Preferred job location: Waltham, MA. Remote candidates will be considered on a case-by-case basis or relocation may be provided.

Key Responsibilities Include:

• Enterprise Safety Leadership
  
  
  
  • Define and execute the vision, strategy, and roadmap for Medical Safety Science across all therapeutic areas and lifecycle stages.
  • Serve as a top safety expert and executive advisor to R&D, Regulatory, Medical Affairs, Commercial, Legal, and senior leadership.
  • Lead 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
  
  
  
  • Lead global safety input into interactions with health authorities, including FDA, EMA, and PMDA.
  • Serve as a company representative in regulatory negotiations and safety-related inspections.
  • Ensure all safety 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
  
  
  
  • Lead safety 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.
  
  
  
  

Education, Registration & Certification:

• MD/DO/Equivalent required; specialty training or board certification preferred.

Experience:

• 15+ 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.
• Therapeutic experience in nephrology or ophthalmology preferred.
• Executive-level communication and influencing skills; proven ability to operate effectively with executive teams and external stakeholders.

Physical Demands and Work Environment:

This is largely a sedentary role; however, some filing is required. This would require the ability to lift files, open filing cabinets and bend or stand on a stool as necessary. This job operates in a professional office environment and routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

Travel Requirements:

• Up to 15% travel expected.

Benefits and Perks:

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! Visithttps://apellis.com/careers/ to learn more.

Company Background:

Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company that combines courageous science and compassion to develop life-changing therapies for some of the most challenging diseases patients face. We ushered in the first new class of complement medicine in 15 years and now have two approved medicines targeting C3. These include the first and only therapy for geographic atrophy, a leading cause of blindness around the world. With nearly a dozen clinical and pre-clinical programs underway, we believe we have only begun to unlock the potential of targeting C3 across many serious diseases.

For more information, please visithttp://apellis.comor follow us onTwitterandLinkedIn

EEO Statement:

Apellis is an equal opportunity employer and complies with all applicable federal, state and local fair employment practices laws. Apellis strictly prohibits and does not tolerate discrimination against employees, applicants or any other covered persons because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including gender nonconformity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, marital status, AIDS/HIV status, smoker/nonsmoker, and occupational pneumoconiosis or any other characteristic protected under applicable federal, state or local law.

For San Francisco postings: Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records.

Other Duties:

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.