Vice President, Early Clinical Development

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Cambridge, MA, US

3 days ago Requisition

Salary Range: $ To $ Annually

Immuneering Corporation (Nasdaq: IMRX) is a clinical-stage biopharmaceutical company developing oncology therapies using its proprietary Deep Cyclic Inhibition platform. Our lead asset, atebimetinib (IMM-1-104), is an oral, once-daily Deep Cyclic Inhibitor of MEK in active Phase 2 and Phase 3 (MAPKeeper 301) clinical trials in pancreatic cancer and RAS-mutant non-small cell lung cancer, as well as additional solid tumor programs. We are committed to delivering transformative treatments to patients with limited options through rigorous science and a collaborative, mission-driven culture.

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.

• 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.

• 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.

• 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.

Immuneering Corporation is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will…