Associate Director, Translational Medicine

Associate Director, Translational Medicine & Clinical Science - San Francisco Bay Area

ABOUT THE ROLE

The Associate Director of Translational Medicine will support clinical-stage programs as an individual contributor, working closely with clinical development, pharmacology, bioanalytical, regulatory, and other cross-functional teams.

The role focuses on developing and executing translational strategies across PK, PD, biomarker, and immunogenicity workstreams, as well as analyzing translational datasets and authoring study reports to support clinical development and regulatory submissions. The individual will serve as a translational medicine lead within clinical study teams and contribute to both clinical and select preclinical/IND-enabling activities.

This is a full-time, hybrid role based in South San Francisco, requiring onsite presence 2-3 days per week.

KEY RESPONSIBILITIES

• Lead translational medicine input for clinical studies across development phases
• Develop and execute translational strategies for PK, PD, biomarker, and immunogenicity assessments
• Analyze, interpret, and summarize translational datasets in support of clinical decisions and regulatory filings
• Author translational study reports and contribute to clinical study reports and regulatory documentation
• Collaborate with clinical pharmacology, bioanalytical, clinical operations, and regulatory teams
• Support PK analysis and modeling efforts with pharmacology partners
• Contribute to regulatory interactions, including preparation of briefing materials and technical documentation
• Support selected preclinical/IND-enabling studies, including PK/PD and toxicology-related activities
• Partner with internal and external scientific collaborators as needed

QUALIFICATIONS

• Advanced degree required (PhD + ~8 years, or Master’s + ~12 years of relevant experience)
• Experience in clinical drug development (early and/or late stage)
• Strong background in translational medicine, clinical pharmacology, or related field
• Experience contributing to regulatory submissions (e.g., IND, BLA, or global equivalents)
• Strong understanding of PK, PD, biomarker, and immunogenicity data
• Experience working in cross-functional clinical development teams
• Strong scientific writing and documentation skills under GxP standards
• Ability to manage multiple priorities in a fast-paced environment
• Experience with toxicology or external CRO collaborations is a plus

If interested, please reach out to View email address on click.appcast.io.