- Work independently, with project teams and vendors to develop and execute clinical pharmacology strategies, including analysis and modeling of PK/PD samples for selection of dose/regimen for drug candidates from preclinical to IND and eventually NDA stage
- Serve as the subject matter expert on cross-functional teams to lead projects, direct GLP bioanalytical validations and sample analysis across all nonclinical, DMPK and clinical pharmacology development
- 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
- 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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Head, Clinical Pharmacology - Cambridge, United States - Leap Therapeutics
Description
Company Summary
Leap Therapeutics (Nasdaq: LPTX) is focused on developing targeted and immuno-oncology therapeutics. Leap's most advanced clinical candidate, DKN-01, is a humanized monoclonal antibody targeting the Dickkopf-1 (DKK1) protein. DKN-01 is being developed in patients with esophagogastric, gynecologic, and colorectal cancers. FL-301, is a humanized monoclonal antibody targeting Claudin18.2, being developed in patients with gastric and pancreatic cancer. Leap also has preclinical antibody programs targeting Claudin18.2/CD137 and GDF15. For more information about Leap Therapeutics, please visit
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
Education / Experience / Skills:
Leap is an equal opportunity employer and extends equal opportunity to all individuals, without regard to race, color, creed, ancestry, national origin, citizenship, sex or gender (including pregnancy, childbirth, and pregnancy-related conditions), gender identity or expression (including transgender status), sexual orientation, marital status, religion, age, disability, genetic disposition, caregiver status, reproductive health decisions, status as a victim of domestic violence, sexual violence or stalking, credit history, criminal history, service in the military, or any other characteristic protected by applicable federal, state, or local laws and ordinances. We are committed to creating and maintaining a workplace in which all employees have an opportunity to participate and contribute to the success of the business and are valued for their skills, experience, and unique perspectives.
