VP Early Clinical Development, Translational Medicine
Overview
Own company-wide translational medicine, clinical biomarker, bioanalytical, and companion diagnostic strategy for a clinical-stage oncology portfolio. Drive atebimetinib (IMM-1-104) through Phase 2 and 3 trials in pancreatic and RAS-mutant lung cancer. Lead a high-performing team integrating PK/PD, immunogenicity, and fit-for-purpose assays to inform dose selection and patient stratification. Partner with DMPK, Clinical Pharmacology, Regulatory Affairs, and Biostatistics to advance programs from IND-enabling studies through registration. This role shapes precision medicine frameworks and external IVD partnerships, with direct impact on Go/No-Go decisions.
What You'll Do9
- 1Develop integrated translational medicine and biomarker strategies for oncology programs from discovery through Phase 0-3.
- 2Define proof-of-mechanism, pharmacodynamic, patient-selection, immunogenicity, and exploratory biomarker plans aligned with clinical goals.
- 3Integrate PK/PD and biomarker data into dose and development decisions with DMPK, Clinical Pharmacology, and Toxicology teams.
- 4Lead fit-for-purpose assay development, qualification, validation, and transfer under GLP, GCLP, CLIA, and CAP standards.
- 5Establish companion diagnostic and precision medicine strategies, including external IVD partnerships and regulatory planning.
- 6Author biomarker and bioanalytical sections of INDs, protocols, briefing documents, and clinical study reports; support FDA and EMA interactions.
- 7Oversee CROs, central laboratories, biospecimen operations, budgets, contracts, and quality timelines.
- 8Chair translational governance and deliver clear recommendations for dose optimization and patient stratification.
- 9Build and mentor a translational and bioanalytical team; represent the company at scientific meetings and collaborations.
Requirements8
- 115+ years in biotechnology or pharmaceuticals with executive-level leadership in translational medicine.
- 2Advanced degree (PhD, MD, or PharmD) in immunology, pharmacology, oncology, molecular biology, or related field.
- 3Deep expertise integrating ADME/DMPK, PK/PD, immunogenicity, biomarker, and clinical pharmacology strategies.
- 4Proven record building translational biomarker frameworks for first-in-human and later-stage studies, including proof-of-mechanism and patient-selection endpoints.
- 5Experience with flow cytometry, multiplex platforms, cell-based assays, multi-omics, and regulated bioanalysis.
- 6Strong knowledge of companion diagnostics, precision medicine, and assay validation.
- 7Experience with IND-enabling packages, pre-IND, INTERACT, and Type C health-authority interactions.
- 8Demonstrated ability to manage CROs, negotiate contracts, and maintain quality oversight.
Salary Insight
$348 - $400k per year
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