Apellis Pharmaceuticals
Biotechnology • Pharmaceuticals • Healthcare Insurance
Apellis Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of innovative therapeutic treatments targeting the complement system. The company is dedicated to transforming the treatment landscape for debilitating diseases, with a particular focus on ophthalmology and rare diseases. Apellis is committed to advancing complement science to address unmet medical needs through its robust pipeline of clinical trials and approved products. With a keen emphasis on patient-centered approaches and community engagement, Apellis strives to deliver breakthrough therapies to improve patient outcomes.
Senior Director, Clinical Science
Job not on LinkedIn
October 29
Apellis Pharmaceuticals
Biotechnology • Pharmaceuticals • Healthcare Insurance
Apellis Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of innovative therapeutic treatments targeting the complement system. The company is dedicated to transforming the treatment landscape for debilitating diseases, with a particular focus on ophthalmology and rare diseases. Apellis is committed to advancing complement science to address unmet medical needs through its robust pipeline of clinical trials and approved products. With a keen emphasis on patient-centered approaches and community engagement, Apellis strives to deliver breakthrough therapies to improve patient outcomes.
📋 Description
• Establishes the clinical science competency built on a positive organizational culture grounded in clinical scientific expertise. • Manages a team of Clinical Scientists (across all levels). Ultimately responsible for leading multidisciplinary teams in the design, planning, execution, and interpretation of clinical development plans across all stages of development. • Represents Clinical Development in leadership and governance meetings/committees. • Partners with therapeutic area Medical Directors and R&D colleagues to advance drug development, clinical design strategy, and program prioritization across R&D portfolio of programs. • Leads and supports cross-functional clinical development teams, represents clinical development on program teams, and liaises as needed with project teams. • Builds credible relationships with external partners (e.g., principal investigators, key opinion leaders) and represents the company to relevant health authorities and consultant/advisory meetings. • Builds and manage a strong Clinical Scientist team with responsibility for establishing the team strategy, resource planning, talent development, and management. • Performs Clinical Scientist responsibilities on key programs as needed. • Remains up to date on current regulations, guidelines, and scientific advances relevant to Apellis. • Facilitates cross-functional collaboration with Translational Medicine to transition research stage assets to clinical development. • Manages Clinical Scientists in the timely and thorough review of study data using best practices and available tools to identify and evaluate trends. • Participates in due diligence activities as requested. • Leads non-study cross functional activities or initiatives. • Travel to field sites, internal and external meetings, and conferences as needed.
🎯 Requirements
• MD/OD/PhD in related life science discipline preferred, with relevant clinical development experience. • 8+ years of clinical development in the pharmaceutical/biotech industry including multiple years in a leadership role. • Previous experience in drug development is required. • Experience in analysis and interpretation of clinical data (safety and efficacy) and a working knowledge of biostatistics, GCP, and regulatory requirements for clinical studies. • Experience interacting with clinical investigators and medical experts.
🏖️ Benefits
• 401(k) plan with company match • Inclusive family building benefits • Flexible time off • Summer and winter shutdowns • Paid family leave • Disability and life insurance
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