Enliven Therapeutics is a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule inhibitors to help people with cancer not only live longer, but live better. The Company aims to address existing and emerging unmet needs with a precision oncology approach that improves survival and enhances overall well-being. Its discovery process combines deep insights in clinically validated biological targets and differentiated chemistry with the goal of designing therapies for unmet needs.

Summary

The Director/Senior Director, Clinical Pharmacology, is responsible for providing clinical pharmacology input in early and late-stage clinical development.  The D/SD will represent clinical pharmacology function on drug development teams, provide input on the dose, PK, DDI, and other related elements of early and late-stage clinical trials, and provide guidance on clinical trial operations on clinical pharmacology related issues.  The D/SD will provide strategic input on the clinical development of the compound and will be responsible for design and performing clinical pharmacology studies, such as human ADME, special population PKPD, and drug-drug interaction studies. The D/SD will contribute to the preparation of the regulatory documents such as briefing books for pre-agency meetings, IBs, INDs, and IMPD dossiers, protocols, and clinical study reports. 

The D/SD will closely collaborate with other development-functions (Toxicology, Bioanalytical, Non-clinical PK/PD, Biomarkers, Biostatistics and Data Management, Clinical Operations, and Clinical Development) to bring drug candidates from IND stage to NDA.   The clinical pharmacologist should have sound knowledge on preclinical ADME and PBPK modeling. It is preferable to have hands-on modeling experience using one of the PBPK software, such as PKSIM, GastroPlus, or SimCYP, but not a strict requirement.

Principal Responsibilities

• Responsible for the preparation of the clinical pharmacology sections of early and late-stage clinical protocols, Clin Pharm development plans, and M&S plans
• Contribute to the preparation of the pre-IND, IND, IB and IMPD documents
• Establish in-house capability of PBPK modeling and conduct PBPK modeling work for key compounds in clinical development
• 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)
• Responsible for recommending the starting dose in FIH trials based on allometric scaling or quantitative modeling
• Conduct assessments of relevant exposure vs. response data for supporting dose selection during and post POC
• Contribute to the design of late-stage clinical trials (POC-BLA/NDA)
• Responsible for leading the recommendation for the starting dose in Phase II and III clinical trials based on PK, PD biomarker and efficacy data analysis from previous studies.
• Contract and monitor CRO for clinical pharmacology projects, such as popPKPD analysis, clinical pharmacology studies
• Represent Clin Pharm function for the project team at the regulatory agencies during regulatory meetings.
• Provide clinical pharmacology input and collaborate across all areas of drug development, along with research, preclinical, bioanalytical and clinical development functions.

• PhD with More than 8 years (or MS with more than 10 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, and

The expected salary range for this is $220,000-$280,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This is a full-time remote position (40 hours/week). Occasional evening, weekend, holiday, and on-call work may be required as job duties demand. Occasional travel may be required. 

Enliven Therapeutics is proud to be an equal opportunity employer. All employment offers are contingent upon the applicant successfully completing a background screen.