Senior Director, Clinical Science

Apellis Pharmaceuticals • Waltham, MA

58d • $242,000 - $363,000

About The Position

Opportunity awaits those up to the challenge of developing transformative therapies across a broad range of debilitating diseases. Summary: The Sr. Director, Head of Clinical Science, is a key member of our clinical development team and is a major contributor to the development and execution of the clinical strategy for our clinical development programs. The successful candidate will interface with the entire clinical team to provide scientific expertise, and will also have opportunities to make strategic and scientific impacts on current and future clinical programs.

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.
• 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.
• Travel Requirements: Up to 30% travel (domestic and international).

Responsibilities

• 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.

Benefits

• 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!
• Visit https://apellis.com/careers/benefits/ to learn more.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree