Sr. Director, Pipeline Development Lead

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

Key Responsibilities Include:

• R&D Strategy Leadership:
  • Act as the sole Development representative on the cross-functional pipeline strategy team, ensuring that R&D priorities and strategies are aligned with business and regulatory goals throughout the development process by actively soliciting input from Development leadership and functional teams to inform strategic decisions and accurately represent Development perspectives.
  • Provide strategic oversight for early-stage clinical development activities to efficiently demonstrate clinical POC, ensuring they align with the company’s long-term objectives.
  • Drive the development of Integrated Asset Plans, Target Product Profiles, Regulatory Strategies, and Lifecycle Management Strategies, integrating the R&D perspective to support the broader strategy.
  • In conjunction with leaders from Research and Discovery, ensure consistent communication and alignment on program direction and execution with key functions on the pipeline strategy team (Commercial, Technical Operations, Medical, Corporate Strategy).
  • Ensure the R&D strategy supports timely and effective regulatory submissions to facilitate product development and approval.
  • Ensure efficient and directive decision-making within the strategy team, contributing to the development and refinement of program strategies, including clinical trial design, regulatory submissions, and lifecycle management.
  • Identify and proactively address potential risks or obstacles that could impact the development timeline or program success, collaborating with functional leads to mitigate issues effectively.

• Scientific Expertise & Guidance:
  • Provide expert scientific guidance across all stages of drug development, ensuring the design and execution of efficient clinical strategies are scientifically rigorous and aligned with company goals.
  • Shape the scientific direction for one or more programs, staying informed on emerging scientific trends and ensuring the integration of innovative approaches into development plans.
  • Serve as the internal and external scientific expert on assigned programs, providing in-depth knowledge of the disease indications, treatment landscapes, and drug development strategies.
  • Provide mentorship and guidance to R&D team members, fostering a culture of scientific excellence, accountability, and continuous improvement.
  • Serve as a key resource for the broader organization, offering deep scientific and technical expertise in drug development to elevate enterprise thinking and capabilities of drug development.
  • Contribute to the development of R&D talent, ensuring the team remains at the forefront of scientific innovation and industry best practices.
  • Contribute to the evaluation of new technologies, scientific platforms, and therapeutic approaches that align with the company’s strategic objectives.
  • Provide scientific input into business development opportunities, including partnerships, licensing agreements, and acquisitions within the relevant therapeutic areas.
  • Play an integral role in shaping the scientific vision and future direction of the company through one or more key programs, including identifying emerging scientific trends and new opportunities for innovation.

Education, Registration & Certification:

• Bachelor's degree in Life Sciences required, advanced degree in Life Sciences (PhD, MD, M.Sc., Pharm.D., or equivalent) preferred

Experience:

• At least 10 years of drug development experience in the biotech or pharmaceutical industry, with a minimum of 5 years in leadership roles within R&D.
• Extensive experience in scientific leadership and deep expertise across the entire drug development lifecycle, from early-stage research through clinical development and regulatory submission.
• Proven track record in leading scientific strategy, clinical trial design, and regulatory submissions in a cross-functional environment.
• Expertise in developing and executing innovative scientific strategies and ensuring their alignment with company goals across preclinical and clinical stages.
• In-depth experience in identifying scientific opportunities and challenges, particularly in translating complex scientific data into actionable development plans.

Skills, Knowledge & Abilities:

• Scientific Expertise: Deep knowledge of drug discovery and development processes, including preclinical research, clinical development, regulatory strategies, and lifecycle management as well as pharmacology, toxicology, formulation science, and biostatistics. Ability to provide high-level scientific guidance across various therapeutic areas, with a strong focus on ensuring scientific rigor in program execution.
• Strategic Oversight: Ability to integrate scientific insights into strategic development decisions, including clinical trial design, regulatory strategies, and market entry planning.
• Expertise in Regulatory Pathways: Strong understanding of the regulatory landscape, including experience with IND/CTA submissions, clinical trial design, and global regulatory requirements.
• Communication: Exceptional ability to communicate complex scientific concepts and data to both technical and non-technical stakeholders, ensuring alignment across functional teams and leadership. Strong executive presence with the ability to influence individuals at all levels.
• Innovation & Trends: Proven ability to identify emerging scientific trends, technologies, and therapeutic approaches that can inform development strategies and enhance the drug development pipeline.
• Cross-functional Collaboration: Proven success in leading scientific discussions and aligning R&D strategies across functions, ensuring scientific objectives are met while supporting broader business goals.
• Problem-Solving & Decision-Making: Strong critical thinking and problem-solving skills, with the ability to synthesize scientific data and address technical challenges in a timely and effective manner.

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. 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 20% 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.