Director, Clinical Science

Director, Clinical Science

San Diego, CA - Hybrid

$200,000 - 230,000

The Director of Clinical Science will lead and contribute to the design and execution of clinical studies in oncology. This role involves partnering with clinical operations, translational teams, and other team members to develop and refine clinical plans, author key clinical and regulatory documents, and ensure the delivery and interpretation of clinical data. The Director will also drive study enrollment and build collaborative relationships with investigators, clinical site staff, CROs, and colleagues. A proactive and thoughtful approach to clinical study execution is essential, with a focus on anticipating and resolving obstacles.

Key Responsibilities:

• Lead and contribute to study design and amendments in collaboration with internal and external scientific stakeholders.
• Collaborate with MDs, regulatory partners, and other stakeholders to author and submit protocols, amendments, regulatory filings, and other documentation.
• Work with clinical operations, data management, and CROs to develop and implement data quality plans, and lead internal medical data review and safety trend analysis for studies/programs.
• Serve as the point-of-contact for clinical inquiries from CRO medical monitors and other stakeholders.
• Develop and provide input for clinical presentation slides and materials for internal/external meetings and communications (e.g., investigator meetings, site selection visits, training sessions, newsletters).
• Partner with clinical operations and CROs to develop and maintain study start-up documents/resources (e.g., ICF, Lab Manual, EDC, Safety Monitoring Plan).
• Participate in safety meetings, track, analyze, and review documentation for potential safety events.
• Lead and contribute to the development and implementation of communication strategies to support ongoing and concluded studies, including KOL interactions, advisory boards, medical meetings, congresses, publications, and other materials.
• Write and/or review abstracts, posters, and content for scientific meetings, conferences, and other events, and coordinate reviews with internal partners and stakeholders.
• Coordinate submissions to scientific meetings and other appropriate venues.
• Write clinical science sections of meeting packages and assist in the development and review of other clinical documentation required for regulatory submissions and processes.
• Perform other duties as assigned.

Qualifications:

• MS (or equivalent) required; PhD, PharmD, or MD preferred.
• Minimum of 5+ years of related experience with a PhD or equivalent degree; at least 2 years of experience in conducting/supporting oncology/hematology clinical studies.
• Excellent written and verbal communication skills.
• Expertise in interpreting immunology/immuno-oncology translational data and clinical data.

If you are interested, please apply!