Senior Medical Director of Ophthalmology, Clinical Development

Position Summary:

The Senior Medical Director of Ophthalmology, Clinical Development holds the responsibility to lead several clinical development programs the ophthalmology franchise. This individual will be the primary point person for medical monitoring and oversight of assigned clinical programs including monitoring of clinical studies, review & interpretation of clinical trial data, authoring clinical study and regulatory communications and documents, and monitoring of competitor activities and data. This individual will play a crucial role in formulating the company’s ophthalmology pipeline and portfolio expansion, working closely with the research and commercial departments.

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

Key Responsibilities Include:

• Designing and implementing the ophthalmology clinical development strategy and clinical protocols and delivering high quality clinical programs, from first-in-human trials, through to full development and post-marketing.
• Serve as the therapeutic area lead of the ophthalmology development team, partnering closely with heads of development operations, pharmacovigilance, clinical quality, and biostatistics.
• Provide medical leadership for key areas of clinical operational strategy, particularly with respect to site selection, enrollment, feasibility, etc., and serve as primary, point of escalation for all issues identified which may affect the quality and integrity of clinical studies.
• Medical monitoring, coding, and data cleaning in collaboration with Clinical Operations.
• Ensure the medical integrity of clinical study reports and data interpretation/communication.
• Author or oversee authorship of clinical sections of regulatory submissions (INDs, briefing books, BLAs, NDAs, etc.) and represent the company at regulatory meetings including presentation at Advisory Committee Meetings.
• Preparing safety charters, DMC charters, or other specific management plans and manuals in a cross-functional team.
• Supporting or preparing data interpretation and clinical trial reports.
• Preparing Investigator Alert letters and SAE reports in collaboration with Clinical Operations as required.
• Represent the company to external stakeholders supporting the conduct of clinical trials, including CROs, clinical consultants, investigational sites, etc.
• Represent Clinical Development in cross-functional forums to align on strategic priorities, resolve operational challenges, and ensure seamless execution across departments.
• Develop and manage budgets required to implement clinical development plans and regularly report plan progress to stakeholders.
• Be an active participant with the corporate leadership team on the strategic direction of business and provide guidance on opportunities/hurdles that may be forecasted.
• Support business development, potential product evaluation, and due diligence.
• Provide medical/clinical expertise to internal (Marketing, Sales, Manufacturing, Managed Care, Regulatory Affairs, R&D, and Legal) and external (healthcare professionals, data safety monitoring boards, patients, advocacy groups, etc.) customers.
• Coach, manage, and mentor direct reports, while providing job enrichment and developmental opportunities.

Education, Registration & Certification:

• MD, DO, or foreign equivalent required.
• Board certification in ophthalmology strongly preferred.

Experience:

• 8+ years of ophthalmology clinical development experience primarily in the biopharmaceutical industry.
• Demonstrated leadership in advancing ophthalmology clinical programs through multiple phases of development.
• In-depth knowledge of ICH-GCP, regulatory requirements, and clinical trial methodology in ophthalmology.
• Experience interacting with global regulatory agencies and health authorities.
• Strong cross-functional collaboration skills with demonstrated experience representing Clinical Development in internal strategic and operational forums.
• Experience in biotech/startup environments preferred.

Travel Requirements:

• Up to 20% travel expected.

Benefits and Perks:

Apellis offers a great benefit package which includes: health insurance with full premium coverage, 401K with company match, paid time off (PTO), long- term disability insurance, life insurance and more! Visit https://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.