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Associate Director, Clinical Pharmacology
Enliven TherapeuticsAssociate Director of Clinical Pharmacology responsible for providing clinical pharmacology input on drug development. Collaborating across development functions at Enliven Therapeutics.
About the role
Key responsibilities & impact- 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
What you’ll need- 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
Comp & perks- Benefits are included
- Other incentives such as bonus and equity may be provided
ATS Keywords
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Hard Skills & Tools
clinical pharmacologypharmacokineticspharmacodynamicsnoncompartmental PK analysisPK/PD analysisstatistical analysis methodssmall molecule drug developmentPBPK modeling
Soft Skills
written communicationoral communicationpresentation skillscollaboration
Certifications
PhDMS