Associate Director, Clinical Pharmacology

Position Title: Associate Director, Clinical Pharmacology

Job Status: Exempt, Full Time

Location:  Remote 

Department: Clinical Pharmacology

Company Overview

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.

Role Summary 

The Associate Director, Clinical pharmacology, is responsible for providing clinical pharmacology input in early and late-stage clinical development. The AD will represent clinical pharmacology function in clinical study teams, provide clinical pharmacology input on the dose, PK, DDI, and other related elements of early and late-stage clinical trials, and provide guidance on CP related issues during clinical trial execution. The AD will participate in the study design and execution of clinical pharmacology studies, such as human ADME, special population PKPD, and drug-drug interaction studies. The AD will contribute to the preparation of the regulatory documents such as briefing books for regulatory meetings, INDs, and IMPD dossiers, protocols, and clinical study reports. The AD 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 small molecular ADME. Applicants who have sound modeling and simulation experience, but no DMPK experience, are also welcome. It is preferable to have hands-on modeling experience with PBPK modeling, popPK, or PKPD modeling, but not a strict requirement.

Core Role Responsibilities:

• 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.

• 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

The annual salary range Enliven reasonably and in good faith expects to pay for this position at the time of this posting is $185,000 - $215,000. The actual salary offered will be determined based on factors such as experience, qualifications, skills and expertise, geographic location, and other job-related factors permitted by law. Benefits are included and other incentives such as bonus and equity may be provided. This range is subject to change based on business needs, job scope changes, market conditions, and individual qualifications. Employees and applicants may request the pay range for their position or for a position to which they are applying. 

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

Notice to agencies: Our in-house Talent Acquisition Team manages all employment opportunities at Enliven. Agencies and independent recruiters must be approved as a vendor by our HR team. To protect the interests of all parties, Enliven will not accept unsolicited resumes, profiles, or biographies. Any unsolicited submissions will be considered referrals and become the property of Enliven. Contacting hiring managers, executives, or any member of the HR team will not influence vendor approval and is strongly discouraged. Repeated outreach may impact future consideration.