Director, Clinical Pharmacology

Description

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.

Requirements

• •PhD with 8+ years, or MS with 12+ years, of relevant pharmaceutical or biotechnology industry experience in clinical pharmacology and drug development, with significant experience supporting early clinical development.
• •Experience with small-molecule drug development is required, with strong knowledge of clinical pharmacology, ADME, PK, PK/PD, exposure-response, DDI, and dose selection and optimization.
• •Demonstrated ability to develop clinical pharmacology strategies and integrate emerging clinical data to inform study design and dose-selection decisions.
• •Hands-on experience with noncompartmental PK analysis and interpretation of clinical PK/PD data; experience with Phoenix WinNonlin and/or R is preferred.
• •Knowledge of model-informed drug development and quantitative approaches, including population PK, PK/PD, exposure-response, and PBPK modeling; hands-on modeling and simulation experience is a plus.
• •Experience with authoring and reviewing clinical pharmacology content for regulatory submissions and supporting interactions with FDA and other global regulatory agencies.
• •Knowledge of relevant FDA, EMA, and ICH guidance is required.
• •Experience in managing CROs, consultants, and other external partners.
• •Strong scientific judgment, critical-thinking, problem-solving, communication, and presentation skills, with the ability to work independently and collaborate effectively across functions in a fast-paced biotechnology environment.

The annual salary range Enliven reasonably and in good faith expects to pay for this position at the time of this posting is $220k - $260k. The actual salary offered will be determined based on factors such as experience, qualifications, skills and expertise, geographic location, and other job-related factors permitted by law. Benefits are included and other incentives such as bonus and equity may be provided. This range is subject to change based on business needs, job scope changes, market conditions, and individual qualifications. Employees and applicants may request the pay range for their position or for a position to which they are applying.

Enliven Therapeutics is proud to be an equal opportunity employer . All employment offers are contingent upon the applicant successfully completing a background screen.

Notice to agencies: Our in-house Talent Acquisition Team manages all employment opportunities at Enliven. Agencies and independent recruiters must be approved as a vendor by our HR team. To protect the interests of all parties, Enliven will not accept unsolicited resumes, profiles, or biographies. Any unsolicited submissions will be considered referrals and become the property of Enliven. Contacting hiring managers, executives, or any member of the HR team will not influence vendor approval and is strongly discouraged. Repeated outreach may impact future consideration.