Director, Clinical Pharmacology

Clinical Pharmacology Lead

Lead Clinical Pharmacology strategy across early and late stage development, integrating PK, PD, exposureresponse, 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 exposureresponse 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 (please note this is an individual contributor role): 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.

Qualifications

Education: PhD or PharmD (or MS with significant industry experience) in Clinical Pharmacology, Pharmacokinetics, Pharmaceutical Sciences, or related quantitative field required.

Experience: 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 13.

Technical depth:

• Population PK/PD modeling (NONMEM, Monolix), PBPK (Simcyp, GastroPlus), and exposureresponse 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.

Technical / Soft Skills

Strong experience working as an individual contributor. This is a single employee function expected to collaborate with internal functions for success. Exceptional scientific communication, cross functional influence, vendor management, and decision making in fast paced settings. Must embody Immuneering's core values of: Data Rules, Humble, All In, Care and Own It (accountability).

Physical Demands/ Working Conditions

Requires prolonged sitting, some bending, stooping, and stretching. Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Requires normal range of hearing and eyesight to record, prepare and communicate appropriate reports. No significant lifting is associated with the role.

Immuneering is an equal opportunity employer. We are committed to creating a diverse and inclusive workplace where all employees are treated with fairness and respect. We do not discriminate on the basis of race, ethnicity, color, religion, gender, sexual orientation, age, disability, or any other legally protected status. Our hiring decisions and employment practices are based solely on qualifications, merit, and business needs. We encourage individuals from all backgrounds to apply and join us in our mission.

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