Director of Clinical Pharmacology

Director, Clinical Pharmacology (DMPK Focus)

Position Summary

We are seeking an experienced Director of Clinical Pharmacology with strong expertise in DMPK to lead clinical pharmacology strategy across discovery, translational, and clinical development programs. This individual will play a critical role in advancing pipeline assets by integrating PK, PD, exposure response, modeling and simulation, and translational sciences into development decisions.

The ideal candidate will bring deep scientific expertise in clinical pharmacology and DMPK, coupled with cross functional leadership experience in biotech or pharmaceutical environments. This role will partner closely with Research, Translational Medicine, Clinical Development, Biometrics, Regulatory, and External CRO partners to optimize dose selection, study design, and overall development strategy.

Key Responsibilities

• Lead and develop clinical pharmacology and DMPK strategies for small molecule and/or biologic development programs from IND through late stage clinical development

• Provide scientific leadership on PK/PD, exposure response analyses, dose optimization, and translational modeling approaches

• Design and oversee clinical pharmacology studies including SAD/MAD, food effect, DDI, hepatic impairment, renal impairment, QTc, and population PK studies

• Drive integration of preclinical DMPK and translational data into clinical development planning and regulatory strategy

• Support first in human dose selection and dose escalation strategies using mechanistic and model informed approaches

DMPK & Modeling Leadership

• Collaborate with discovery and nonclinical teams to interpret ADME, PK, and toxicology data to support candidate selection and development decisions

• Oversee population PK, PBPK, and exposure response modeling activities performed internally or through external partners

• Evaluate metabolite identification, enzyme/transporter interaction data, and bioanalytical strategies to inform clinical development

• Provide strategic guidance on formulation bridging, bioavailability, and biopharmaceutics considerations

• Ensure compliance with regulatory expectations and industry best practices related to clinical pharmacology and DMPK

• Maintain awareness of evolving regulatory guidance and emerging scientific approaches within clinical pharmacology

Required Qualifications

• PhD, PharmD, or equivalent advanced degree in Clinical Pharmacology, Pharmaceutical Sciences, Pharmacokinetics, DMPK, or related discipline

• 7-10+ years of industry experience in clinical pharmacology and DMPK within biotech or pharmaceutical settings

• Strong expertise in PK/PD modeling, population PK analyses, exposure response, and translational pharmacology

• Experience supporting regulatory submissions and interacting with FDA and/or global health authorities

• Demonstrated experience advancing programs from preclinical through clinical development

• Excellent cross functional leadership, communication, and strategic problem solving skills

Preferred

• Experience with oncology, rare disease, immunology, CNS, or other targeted therapeutic areas

• Hands on experience with PBPK modeling platforms and model informed drug development approaches