Job Description
Join to apply for the Sr. Director, Development Lead role at Apellis Pharmaceuticals
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.
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) 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
- 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 therapeutic areas, with a focus on scientific rigor.
- Strong understanding of regulatory pathways, including IND/CTA submissions, clinical trial design, and global requirements.
- Exceptional communication skills to convey complex scientific concepts to diverse stakeholders.
- Ability to identify emerging scientific trends and incorporate innovative approaches into development strategies.
- Proven success in leading cross-functional scientific discussions and aligning strategies.
- Excellent problem-solving and decision-making skills, with the ability to synthesize scientific data effectively.
Physical Demands and Work Environment
- This is largely a sedentary role; some filing and lifting files may be required. The role operates in a professional office environment with standard office equipment.
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, paid family leave, disability and life insurance, and more! Visit for details.
Company Background
Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company dedicated to developing life-changing therapies for serious diseases, with a focus on complement medicine. We have two approved medicines targeting C3, including the first therapy for geographic atrophy. We are actively expanding our pipeline with multiple clinical and pre-clinical programs.
EEO Statement
We are an equal opportunity employer committed to diversity and inclusion. We prohibit discrimination based on race, color, religion, sex, age, disability, and other protected characteristics.
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Job Tags
Full time, Flexible hours,