Sr. Director, Clinical Science

Position Summary:

The Sr. Director, Clinical Science, is a key member of our clinical development team, contributing to and providing leadership on the development and execution of the clinical strategy for current and future clinical programs. The successful candidate will lead Clinical Scientists and either directly or indirectly oversee cross-functional teams including clinical operations, data management, biostatistics, regulatory affairs, and medical affairs to ensure successful clinical program execution. The incumbent will have the responsibility, in conjunction with Medical Director Leads, to develop comprehensive clinical development plans, provide scientific expertise, and ensure efficient delivery of clinical trials in a matrixed environment.   

Key Responsibilities Include:

• 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 liases 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.

Education, Registration & Certification:

• MD/OD/PhD in related life science discipline preferred, with relevant clinical development experience.

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.

Skills, Knowledge & Abilities:

• Demonstrated ability to effectively lead, influence and manage within a highly matrixed organization.
• Have and maintain the expertise necessary for clinical development of pharmaceutical products.
• Capable of analyzing and interpreting clinical study results and providing guidance in the preparation of high-quality study reports.
• In conjunction with Medical Writing, responsible for protocol synopses, protocol development, clinical study reports and other relevant clinical documents.
• Proven teamwork skills with established success operating efficiently and collaboratively in multidisciplinary teams.
• Deep expertise of the multidisciplinary drug development, clinical study design & execution, and ability to proactively integrate cross-functional perspectives into the clinical development process.
• Ability to distill complex scientific information, highly effective in presenting, communicating, and discussing scientific/medical topics across audiences.
• In depth knowledge of the global clinical development process, clinical trial requirements, study design, regulatory process and lifecycle management.
• Demonstrated ability to impact Clinical Development effectiveness using well-developed conflict resolution skills.
• Able to positively influence change and drive organizational alignment.
• Ability to effectively manage, develop, and motiv