Head, Clinical Pharmacology

2 weeks ago

Cambridge, United States Leap Therapeutics Full time

**Head, Clinical Pharmacology**:
**Company Summary**:
**General Responsibilities**:
***The Head of Clinical Pharmacology will be responsible for developing and executing the clinical and non-clinical pharmacology strategies for compounds from the pre-clinical stage through first-in-human and into late-stage clinical development. They will support programs by leading efforts on clinical PK, nonclinical PK, DMPK, ADME, PD and ensuring optimal doses and dosing regimens.

**Specific responsibilities include**:

- Independently plan and conduct hands-on analyses, including NCA, population PK and PK/PD analyses, exposure-response analyses, clinical trial simulation using a variety of software tools to answer development questions and to inform clinical development strategy.
- Lead method development and qualification of bioanalytical assays via LC-MS/MS and immunoassays and other platforms for clinical biomarker studies.
- Supervise CRO activities to ensure bioanalytical method development/validation activities conducted with CROs lead to robust methods that support bioanalytical analysis.
- Explore new analytical platforms and lead external vendor setup for biomarkers.
- Analyze, interpret, and summarize nonclinical and clinical pharmacology data and integrate results into the ongoing clinical development strategy.
- Contributes to the design of early and late-stage clinical trials (FIH to Submission) including:

- Non-compartmental analysis for human PK, PD, BM and safety data (including ADA) to guide decision making during dose escalation and dose-response clinical studies.
- Clinical pharmacology and biopharmaceutical aspects for designing key elements trials.
- Write/review/approve relevant sections of clinical study protocols, analysis plans, study reports, and regulatory submissions.
- Develop and maintain collaborative relationship with colleagues within the department, internal stake holders (i.e., Clinical Operations, translational medicine, medical, biometrics, regulatory, CMC, etc.) and external vendors.

**Education / Experience / Skills**:

- PhD in pharmacokinetics, clinical pharmacology, pharmacometrics, drug metabolism, pharmacology, or related discipline
- 10+ years of research and development experience with drug metabolism, with demonstrated experience designing, executing and/or managing outsourced clinical pharmacology and nonclinical studies; experience in small - mid size biotech preferred.
- Hands on experience of PK/PD method development and statistical analyses methods used in analyzing clinical data.
- Demonstrated experience in clinical pharmacology and pharmacokinetics and advancing studies through clinical development.
- Excellent leadership and communications skills
- Experience with managing clinical pharmacology vendors/CROs.
- Hands-on experience in directing strategy and authoring nonclinical, PK and clinical pharmacology sections of regulatory documents.

Current knowledge of FDA regulatory guidance related to nonclinical and clinical pharmacology; experience having direct interaction with FDA, including submission of IND, NDA and other regulatory documents

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