Associate Director, Clinical Pharmacology

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🕒 April 14

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Enliven Therapeutics

WebsiteLinkedInAll Job Openings

11 - 50 employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

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

• Responsible for the preparation of the clinical pharmacology sections of early and late-stage clinical protocols • Contribute to the preparation of the IND, IB and IMPD documents • Be able to conduct noncompartmental PK analysis based on preliminary data using standard industry data analysis software • Contribute to the design of early phase clinical trials (FIH to POC) • Contract and monitor CRO for clinical pharmacology projects, such as popPKPD analysis, clinical pharmacology studies • Represents the Clin Pharm function in project teams • Provide clinical pharmacology input and collaborate across all areas of drug development, along with research, preclinical, bioanalytical and clinical development functions.

🎯 Requirements

• PhD with More than 3 years (or MS with more than 6 years) of industry experience in supporting pharmacokinetics, pharmacodynamics and other clinical pharmacology components of early clinical trials within the pharmaceutical or biotech industry. • Experience with small molecule drug development is required. • Knowledge of oncology drug development is a plus. • Hands on knowledge of PK/PD and statistical analyses methods used in analyzing early clinical phase data • Knowledge of general regulatory process and experience in writing Clin Pharm documents to support IND, EOP1, EOP2, or pre-BLA/NDA meetings with the FDA, EMA and other regulatory agencies • Excellent written and oral communication skills including good presentation skills • Hands-on modeling experience with PBPK modeling platforms is preferable.

🏖️ Benefits

• Benefits are included • Other incentives such as bonus and equity may be provided