Head of Clinical Development

Position Summary:

We are seeking a seasoned clinical development leader to shape and drive the integrated clinical strategy across multiple programs. Reporting to the Chief Research and Development Officer, this individual will lead the clinical development function, overseeing all aspects of strategy, execution, and team leadership. They will be responsible for end-to-end development from first-in-human through registration and post-marketing. The ideal candidate brings deep clinical expertise, strategic foresight, and a strong track record of leading global development programs in a matrixed, fast-paced environment.

Key Responsibilities Include:

Portfolio & Strategy Leadership

• Partner with the broader Research & Development team and other cross-functional leaders to align early- and late-stage clinical development with the overarching corporate strategy.
• Represent development programs in governance forums and provide executive updates on risks, opportunities, and mitigation strategies.
• Contribute to and provide strategic oversight for integrated asset strategies (IAS), including target product profiles (TPPs), research product profiles (RPPs), and lifecycle management strategies.
• Lead and contribute to due diligence and external innovation assessments.

Clinical Development Strategy & Execution

• Lead the clinical development teams, including medical directors, clinical scientists, and translational medicine.
• Oversee the design and execution of clinical trials that meet regulatory, scientific, and commercial objectives.
• Review and guide the development of clinical protocols, investigator brochures, regulatory documents, safety reports, and advisory committee materials.
• Ensure cross-functional alignment with Clinical Operations, Regulatory Affairs, Pharmacovigilance, Biostatistics, and other key partners to deliver high-quality data and timely decision-making.
• Represent the organization in key regulatory interactions and ensure preparedness for global health authority engagements.

Medical Governance & Leadership

• Ensure adherence to the highest standards of medical governance, including GCP compliance and all relevant regulatory requirements.
• Recruit, retain, and develop top clinical talent, fostering a high-performing, inclusive team culture.
• Promote a culture of scientific rigor, transparency, and patient-centered innovation.

External Engagement & Thought Leadership

• Establish and nurture relationships with global key opinion leaders, investigators, academic collaborators, and patient advocacy organizations.
• Through significant expert knowledge of progressive therapeutic areas, represent the company at scientific and medical congresses and in development consortia.
• Stay abreast of scientific advancements and evolving regulatory expectations to ensure ongoing innovation and relevance in development approaches.

Required Qualifications:

• A medical degree (MD) is strongly preferred. In lieu of an MD, candidates must possess a PhD in a closely related scientific field (e.g., biomedical sciences, pharmacology, or a similar discipline).
• Minimum 18 years of clinical development experience, including progressive leadership roles within the biotechnology or pharmaceutical industry; prior leadership experience in a small biotech environment is preferred
• Demonstrated success in leading global development programs through all phases, including regulatory interactions and approvals.
• Hands-on experience with global regulatory bodies (e.g., FDA, EMA), including IND, CTA, and NDA submissions.
• Expertise in trial design, pharmacovigilance, translational research, and benefit-risk evaluation.
• Exceptional communication and stakeholder management skills, including the ability to influence across diverse audiences.
• Proven ability to lead in a matrixed environment and thrive in a dynamic, fast-paced organization.

Travel Requirements:

Must be local to Waltham office or willing to be in office on a hybrid basis (2 - 3 days a week)

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 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.