Associate Director, Clinical Pharmacology
Enliven Therapeutics
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $185,000 - $215,000 per year
Job Level
About the role
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical pharmacologypharmacokineticspharmacodynamicsnoncompartmental PK analysisPK/PD analysisstatistical analysis methodssmall molecule drug developmentPBPK modeling
Soft Skills
written communicationoral communicationpresentation skillscollaboration
Certifications
PhDMS