Director, Clinical Pharmacology

Job not on LinkedIn

🔥 4 minutes ago

🇺🇸 United States – Remote

💵 $220k - $260k / year

⏰ Full Time

🔴 Lead

👨‍⚕️ Medical Director

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Enliven Therapeutics

WebsiteLinkedInAll Job Openings

11 - 50 employees

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

Healthcare • Consulting • Biotechnology

Enliven Therapeutics is a company dedicated to developing innovative solutions for cancer treatment. They focus on creating small molecule kinase inhibitors designed to improve efficacy, safety, and patient convenience. With programs targeting BCR-ABL, HER2, and additional pathways, Enliven Therapeutics aims to enhance the precision and selectivity of cancer therapeutics, combat resistance, and address brain metastases. The company prides itself on a team of experienced drug developers and aims to help cancer patients live longer and better lives.

📋 Description

• Provide clinical pharmacology leadership and scientific input to cross-functional development and study teams • Develop and execute clinical pharmacology strategies integrating nonclinical and clinical PK, PK/PD, exposure-response, safety, efficacy, and biomarker data • Inform study design, dose selection, and dose optimization • Design and oversee 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 population PK, PK/PD, exposure-response, and PBPK modeling • 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, 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 • Collaborate with Clinical Development, Clinical Operations, Biostatistics, Biomarkers, Bioanalytical, Nonclinical PK/PD, Toxicology, Regulatory Affairs, and other functions

🎯 Requirements

• PhD with 8+ years, or MS with 12+ years, of relevant pharmaceutical or biotechnology industry experience in clinical pharmacology and drug development • Significant experience supporting early clinical development • Experience with small-molecule drug development is required • 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 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 managing CROs, consultants, and other external partners • Strong scientific judgment, critical-thinking, problem-solving, communication, and presentation skills • Ability to work independently and collaborate effectively across functions in a fast-paced biotechnology environment • Successful completion of a background screen is required for employment

🏖️ Benefits

• Benefits are included • Bonus may be provided • Equity may be provided