Sr. Director, Development Lead

Position Summary:

Apellis is seeking an experienced and visionary Senior Director, Development Lead to serve as the lead and sole representative from Research & Development (R&D) for one or more cross-functional strategy teams. This senior leadership role will be responsible for providing strategic direction and scientific guidance for R&D activities from ideation through life-cycle management, with a direct impact on the success of key programs and the overall company. As the Development lead, the Senior Director will work closely with senior leaders from Commercial, Technical Operations, Medical, and Corporate Strategy to ensure alignment on key objectives and the seamless integration of R&D strategies across the drug development process. This role will champion the R&D perspective, offering expert scientific and drug development insights while ensuring that R&D activities align with business and regulatory objectives.

The individual will leverage their extensive expertise in drug development to shape the program’s scientific vision, foster innovation, and ensure the efficient and successful progression of programs through clinical development and regulatory approval. Reporting to the Head of Clinical Development, this highly visible role requires a proven leader who can influence and align diverse teams, manage complex projects, and navigate the dynamic and evolving landscape of drug development.

Key Responsibilities Include:

• R&D Strategy Leadership:
  • Act as the sole representative of R&D on one or more cross-functional strategy teams, ensuring that R&D priorities and strategies are aligned with business and regulatory goals throughout the development process.
  • Provide strategic oversight for R&D activities, including drug discovery, preclinical research, and clinical development, 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.
  • Serve as the primary conduit between R&D and other key functions (Commercial, Technical Operations, Medical, Corporate Strategy) to ensure consistent communication and alignment on program direction and execution.
  • Ensure the R&D strategy supports timely and effective regulatory submissions to facilitate product development and approval.
  • Lead R&D 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 research and 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 evaluation 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 the 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) preferre