Senior Director, Medical Safety Science

Opportunity awaits those up to the challenge of developing transformative therapies across a broad range of debilitating diseases.

Summary:

Roles and 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.

Qualifications/Experience

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

• An MPH or equivalent training in epidemiology is 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.

• Therapeutic experience in nephrology or ophthalmology preferred.

• Executive-level communication and influencing skills; proven ability to operate effectively with executive teams and external stakeholders.

Travel Requirements:

Education:

Pay Information:

Work Arrangement:

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! Visit https://apellis.com/careers/benefits/ to learn more.

Company Background:

Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company leading the way in complement science 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 C3-targeting medicines approved to treat four serious diseases. Breakthroughs for patients include the first-ever therapy for geographic atrophy, a leading cause of blindness, and the first treatment for patients 12 and older with C3G or primary IC-MPGN, two severe, rare kidney diseases. We believe we have only begun to unlock the potential of targeting C3 across many serious diseases.

For more information, please visit http://apellis.comor follow us on LinkedIn andX.

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.