Associate Director of Translational Medicine and Clinical Science
Behavioral Health Market Context
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Qualifications
- •Advanced degree required (PhD + ~8 years or Master's + ~12 years of relevant experience)
- •Demonstrated experience in clinical drug development (early and/or late-stage)
- •Strong foundation in translational medicine, clinical pharmacology, or a related field
- •Experience contributing to regulatory submissions (such as IND, BLA, or global equivalents)
- •Solid understanding of PK, PD, biomarker, and immunogenicity data
- •Proven ability to work in cross-functional clinical development teams
- •Exceptional scientific writing and documentation skills adhering to GxP standards
- •Ability to handle multiple priorities in a fast-paced environment
- •5 more items(s)
Responsibilities
- •The Associate Director of Translational Medicine will play a pivotal role in supporting clinical-stage programs as an individual contributor
- •You will collaborate closely with cross-functional teams, including clinical development, pharmacology, bioanalytical, and regulatory, to enhance our clinical research endeavors
- •Your primary focus will be on the development and execution of translational strategies across pharmacokinetics (PK), pharmacodynamics (PD), biomarker, and immunogenicity workstreams
- •Analyzing translational datasets and authoring critical study reports will be essential to supporting our clinical development and regulatory submissions
- •In this role, you will serve as the translational medicine lead within clinical study teams, also contributing to selected preclinical and IND-enabling activities
- •This is a full-time, hybrid position based in South San Francisco, with an onsite presence required 2-3 days per week
- •Lead the translational medicine strategy for clinical studies across various development phases
- •Develop and implement translational strategies for PK, PD, biomarker, and immunogenicity assessments
- •Analyze, interpret, and summarize translational datasets to inform clinical decisions and regulatory filings
- •Author translational study reports and contribute to clinical study documents and regulatory submissions
- •Work collaboratively with clinical pharmacology, bioanalytical, clinical operations, and regulatory teams
- •Support PK analysis and modeling in partnership with pharmacology teams
- •Assist in regulatory interactions, including preparing briefing materials and technical documents
- •Support selected preclinical and IND-enabling studies, focusing on PK/PD and toxicology-related activities
- •Engage with internal and external scientific collaborators as necessary
- •12 more items(s)
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