Director, Clinical Pharmacology

🕒 December 18, 2025

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Immuneering Corporation

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2008

🧬 Biotechnology

💊 Pharmaceuticals

🔥 Funding within the last year

💰 $200M Post-IPO Equity - Immuneering on 2025-09

Biotechnology • Pharmaceuticals

Immuneering Corporation is a clinical-stage biotechnology company developing a novel class of oncology therapies called Deep Cyclic Inhibitors, which use rhythmic dosing to outpace cancer adaptation, improve tolerability, and extend patient survival and quality of life. The company advances a pipeline through clinical trials, collaborates with partners, and emphasizes scientific research and publications to transform cancer treatment while reducing side effects of traditional continuous-inhibition therapies.

📋 Description

• Lead Clinical Pharmacology strategy across early and late stage development, integrating PK, PD, exposure–response, and biomarker data to inform dose selection, regimen, and overall study design. • Own model informed drug development (MIDD) plans (e.g., population PK, PBPK, and quantitative systems approaches) to optimize trial designs and decision points from first in human through pivotal phases. • Author and review CP deliverables for protocols, clinical development plans, IBs, SAPs, and regulatory documents (IND/IMPD/NDA/BLA/MAA), ensuring clarity, traceability, and compliance. • Drive analysis & reporting of PK/PD and exposure–response results (internal and CRO executed), ensuring scientific integrity, reproducibility, and timely insights for program teams and governance. • Establish bioanalytical strategy and standards (method selection/validation, sample handling, and data QC) in partnership with Translational Medicine and external labs/CROs. • Lead Health Authority interactions for CP topics; prepare briefing materials, address IRs, and represent the function in meetings with FDA, EMA, and other agencies. • Provide cross functional leadership with Clinical, Biostatistics, Data Science, CMC, and Regulatory to integrate quantitative evidence into go/no go decisions and portfolio prioritization. • Vendor selection and management for CP related CROs; define scopes, oversee execution, and ensure deliverables meet quality and timeline commitments. • Advance standards & governance (CDISC/ADaM for PK datasets, data pipelines, analysis reproducibility), championing best practices and inspection readiness for a GxP environment. • People collaborations: Must roll up sleeves and be a doer who wants to be into the details themselves. Mentor staff cross functionally and foster an inclusive, high-performance culture consistent with Immuneering values.

🎯 Requirements

• PhD or PharmD (or MS with significant industry experience) in Clinical Pharmacology, Pharmacokinetics, Pharmaceutical Sciences, or related quantitative field required. • Minimum of 5+ years in biotech/pharma Clinical Pharmacology required, more years of experience is a plus, including end-to-end ownership of CP strategy, MIDD, and regulatory submissions across Phase 1–3. • Population PK/PD modeling (NONMEM, Monolix), PBPK (Simcyp, GastroPlus), and exposure–response methods. • Bioanalytical method development/validation oversight and data integrity in GxP contexts. • Authoring high quality CP sections for protocols, IBs, and regulatory dossiers; direct participation in FDA/EMA meetings.

🏖️ Benefits

• Health insurance • Retirement plans • Paid time off • Professional development