General Summary of Duties:
The Vice President will lead company-wide translational medicine, clinical biomarker, bioanalytical, and companion diagnostic strategy across the portfolio. This role will integrate mechanistic biology, PK/PD, immunogenicity, and fit-for-purpose assay development to support dose selection, patient stratification, regulatory interactions, and data-driven advancement from IND-enabling studies through clinical development.
Specific Duties, may include but not be limited to the following:
• Develop and execute integrated translational medicine, clinical biomarker, and bioanalytical strategies for oncology and other priority programs from discovery through Phase 0-3 development.
• Define proof-of-mechanism, pharmacodynamic, patient-selection, immunogenicity, and exploratory biomarker plans aligned with clinical development objectives.
• Partner with DMPK, Clinical Pharmacology, Toxicology, Discovery, Clinical Development, Regulatory Affairs, Biostatistics, and Medical Affairs to integrate PK/PD and biomarker data into dose and development decisions.
• Lead development, qualification, validation, transfer, and implementation of fit-for-purpose assays under GLP, GCLP, CLIA, and CAP expectations, as appropriate.
• Establish companion diagnostic and precision medicine strategies, including external IVD partnerships and regulatory planning.
• Author and review biomarker and bioanalytical sections of INDs, protocols, briefing documents, amendments, and clinical study reports; support FDA and EMA interactions.
• Provide strategic oversight of CROs, central laboratories, diagnostic partners, biospecimen operations, budgets, contracts, quality, and timelines.
• Lead translational governance and provide clear recommendations for dose optimization, patient stratification, and portfolio Go/No-Go decisions.
• Build, mentor, and manage a high-performing translational and bioanalytical team and represent Immuneering at scientific meetings and external collaborations.
Desired Skills and Qualifications
• Executive-level experience leading translational medicine, clinical biomarkers, bioanalytical sciences, and cross-functional drug-development teams.
• Deep expertise integrating ADME/DMPK, PK/PD, immunogenicity, biomarker, and clinical pharmacology strategies.
• Demonstrated experience in oncology, immunology, biologics, and/or advanced therapies, including cell and gene therapy.
• Exceptional written and verbal communication, strategic judgment, scientific curiosity, and collaborative leadership.
Education
• PhD, MD, PharmD, or equivalent advanced degree in immunology, pharmacology, oncology, molecular biology, biomedical sciences, or a related discipline.
• Typically 15+ years of relevant biotechnology or pharmaceutical experience, including significant leadership responsibility. Will consider people with the appropriate combination of education and years of experience holistically.
Technical / Soft Skills
• Proven record building translational biomarker frameworks for first-in-human (Ph0-1) and later-stage studies, including proof-of-mechanism, pharmacodynamic, immune-monitoring, and patient-selection endpoints.
• Experience with flow cytometry, multiplex platforms, cell-based assays, multi-omics, regulated bioanalysis, and biospecimen strategy.
• Strong knowledge of companion diagnostics, precision medicine, assay validation, and external diagnostic partnerships.
• Experience contributing to IND-enabling packages, pre-IND, INTERACT, Type C, and other health-authority interactions.
• Demonstrated ability to manage CROs and vendors, negotiate scopes and contracts, maintain quality oversight, and deliver against timelines and budgets.
• Ability to manage multiple workflows, make sound decisions in a fast-paced environment, and effectively influence cross-disciplinary teams.
• Self-starter who is motivated, ambitious, scientifically rigorous, collaborative, and committed to developing people and teams.
