Director/Senior Director, Clinical Science

$190,000 - $260,000/Yr

Coherus Biosciences - Portola Valley, CA

Full-time - Senior

Remote - Portola Valley, CA

Professional, Scientific, and Technical Services

About the position

The Director/Senior Director, Clinical Science is responsible for leading the design, planning, implementation, and execution of clinical development plans and programs. This role involves collaboration with cross-functional teams to develop clinical strategies, oversee clinical programs, and interact with regulatory agencies. The position requires a strong background in clinical science, particularly in oncology or oncology immunotherapy, and emphasizes the importance of effective communication and data analysis in driving clinical development efforts.

Responsibilities

• Drive the design, planning, implementation, and execution of clinical development plans and programs.
• Partner with cross-functional program team members and key R&D stakeholders to contribute to clinical strategy and development plans.
• Provide clinical support for study conduct, including operational feasibility, data management, and safety monitoring.
• Perform medical and safety/efficacy data reviews and prepare clear overviews of trial results.
• Identify issues related to study conduct and subject safety, providing assessments and recommendations.
• Support data review committees by preparing updates, data reviews, and meeting materials.
• Author protocols and contribute to clinical study reports and regulatory documents.
• Interact with internal and external stakeholders to support program-level strategy and clinical trial objectives.
• Act as a recognized clinical expert for assigned programs and lead the development of scientific content for meetings and publications.

Requirements

• PhD degree in health science field, PharmD, MD or equivalent advanced degree.
• Minimum 7+ years of experience for Director, 12+ years for Senior Director in a pharmaceutical, CRO, or biotechnology company.
• Experience in oncology or oncology immunotherapy clinical trials preferred.
• Early stage drug development experience required.
• Experience with data analysis and interpretation.
• Thorough understanding of the drug development process and functional areas including preclinical, regulatory, and clinical operations.
• Demonstrated ability to communicate and write clearly and effectively.
• Ability to interpret and present clinical data and literature reviews.
• Understanding of trial design and statistics.
• Well-organized with a successful track record of managing multiple projects in a fast-paced environment.
• Impeccable attention to detail.

Benefits

• Base Salary Range: $190,000 - $260,000
• Equal employment opportunities and anti-discrimination policies
• COVID-19 vaccination requirement with accommodation options for disabilities or religious beliefs