Associate Director, Clinical Pharmacology

Job Description

Enliven Therapeutics is seeking an Associate Director of Clinical Pharmacology to contribute to our innovative oncology drug development programs. This role involves preparing clinical pharmacology sections for clinical protocols in early and late-stage development, contributing to IND, IB, and IMPD documents, and conducting noncompartmental PK analysis using industry-standard software. You will help design early-phase clinical trials, manage CROs for clinical pharmacology projects, and represent the Clinical Pharmacology function in project teams. The role requires collaboration across research, preclinical, bioanalytical, and clinical development functions, providing clinical pharmacology input to drive our mission of improving cancer patient outcomes.

Qualifications

1. PhD with 3+ years (or MS with 6+ years) of industry experience in pharmacokinetics, pharmacodynamics, and clinical pharmacology for early clinical trials within the pharmaceutical/biotech industry. 2. Experience with small molecule drug development is essential. 3. Knowledge of oncology drug development is advantageous. 4. Practical knowledge of PK/PD and statistical analysis methods for early-phase clinical data is required. 5. Understanding of regulatory processes and experience writing Clin Pharm documents for IND, EOP1, EOP2, or pre-BLA/NDA meetings with regulatory agencies (FDA, EMA, etc.) is crucial. 6. Excellent written and oral communication and presentation skills are necessary. 7. Hands-on experience with PBPK modeling platforms is desirable.

Benefits

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