Head, Clinical Pharmacology - Cambridge, United States - Leap Therapeutics

Leap Therapeutics

Verified Company

Cambridge, United States

3 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

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 handson analyses, including NCA, population PK and PK/PD analyses, exposureresponse 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 latestage 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.
Handson 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