Director, Clinical Pharmacology

Position Title: Director, Clinical Pharmacology

Job Status: Exempt, Full Time

Location: Remote

Department: Clinical Pharmacology

Company Overview

Enliven Therapeutics is a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule inhibitors to help people with cancer not only live longer but live better. The Company aims to address existing and emerging unmet needs with a precision medicine approach that improves survival and enhances overall well-being. Its discovery process combines deep insights in clinically validated biological targets and differentiated chemistry with the goal of designing therapies

for unmet needs.

Role Summary

The Director, Clinical Pharmacology will provide strategic and operational clinical pharmacology leadership across Enliven’s clinical development programs. This individual will serve as the Clinical Pharmacology representative on cross-functional teams and provide scientific expertise to inform clinical development strategy, study design, dose selection and optimization, and regulatory submissions.

This individual will integrate nonclinical and clinical data to support development decisions and collaborate closely with Clinical Development, Clinical Operations, Biostatistics, Biomarkers, Bioanalytical, Nonclinical PK/PD, Toxicology, Regulatory Affairs, and other functions to advance drug candidates through clinical development. The ideal candidate will have strong expertise in small-molecule ADME and clinical pharmacology, hands-on experience analyzing and interpreting clinical PK data, and the ability to translate quantitative data into actionable development decisions. Experience with modeling and simulation and model- informed drug development (MIDD) is highly desirable.

Core Role Responsibilities

• Provide clinical pharmacology leadership and scientific input to cross-functional development and study teams.
• Develop and execute clinical pharmacology strategies by integrating nonclinical and clinical PK, PK/PD, exposure-response, safety, efficacy, and biomarker data to inform study design, dose selection, and dose optimization.
• Design and oversee clinical pharmacology studies, including human ADME, DDI, food-effect, bioavailability, and special-population studies.
• Perform and/or oversee non-compartmental PK analyses and interpret emerging clinical PK/PD data using standard industry software.
• Apply and/or oversee quantitative modeling approaches, including population PK, PK/PD, exposure-response, and PBPK modeling, to support development decisions.
• Author and review clinical pharmacology content for protocols, Investigator’s Brochures, INDs, IMPDs, briefing documents, clinical study reports, and other regulatory submissions; support regulatory interactions as appropriate. Select and oversee CROs and external consultants supporting clinical pharmacology studies and quantitative analyses, ensuring scientific quality, timelines, and deliverables.
• Review emerging clinical data, identify clinical pharmacology risks and opportunities, and communicate findings and recommendations to cross-functional teams and senior leadership.