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., principle 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 motivate others.
• Highly organized, results driven, problem solver with ability to synthesize, organize, manage, and communicate safety data from various sources.
• Superior written and oral communication skills and the ability to work collaboratively and build relationships with colleagues from different levels of the organization.
• Highly motivated with the ability to be flexible in a fast-paced environment.
• Proven track record of leadership and people management.

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:

• Ability to travel (domestic and international) up to 30% of the time.

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.