Company: Confidential
Job Title: Associate Director/Director, Quantitative Clinical Pharmacology
Job Number: 33198
Location: Remote,
Job Description
The Associate Director/Director level quantitative clinical pharmacologist will play an integral role in both clinical and nonclinical development for this company.
This is a hands-on role, as there are no current direct reports. We expect this department to grow over the next 18 months and this person will help to drive the build out of our future pharmacology team.
They will also be responsible for the development of the model-informed drug development strategy by applying quantitative analysis methods based on integrated nonclinical and clinical PK and PD data.
This role will also work intensively on domestic and international regulatory filing activities and documents. He/she will represent Clinical Pharmacology function and provide subject matter expertise on cross-functional project teams.
This role will also work intensively on domestic and international regulatory filing activities and documents. He/she will represent Clinical Pharmacology function and provide subject matter expertise on cross-functional project teams.
This role reports directly to the VP of Clinical Pharmacology and Translational Medicine.
A core scientific responsibility is ensuring the selection of optimal dose and dosing regimens in patients, and as such, the successful candidate must be able to integrate the knowledge of PK/PD, quantitative modeling and simulation, drug development, TK, and nonclinical ADME and DMPK. Working within the Clinical Development organization, the Associate Director/Director role supports multiple programs through participation on clinical study teams and serves as a liaison between Research and Development organizations.
Responsibilities
Responsibilities
- Design, conduct, and manage clinical pharmacology components of clinical studies, PK and PD analysis and reporting for programs in all stages of drug development.
- Contribute to and lead the design of studies that generate PK and PD data and apply quantitative methods to integrate nonclinical and clinical PK and PD data
- support dose and dosing regimen selection, and optimize study designs throughout drug development.
- Responsible for design and execution of clinical pharmacology strategy including design of clinical pharmacology studies and/or use of alternative modeling approaches.
- Review external data, lead analysis, interpretation and reporting of clinical pharmacokinetic and pharmacodynamic data
- Manage bioanalysis and PK activities at CROs and other external vendors
Required Skills
Qualifications
- Ph.D. or equivalent degree in pharmacokinetics, or related field with 6+ years of experience in thr Life Sciences industry.
- Strong data analysis skills and an in-depth knowledge of pharmacokinetic theory, modeling and simulation methods utilizing the latest computational approaches (e.g, population PK, mechanistic PK-PD, QSP and PBPK) and analysis tools.
- Experience in using common PK / PD modeling software packages WinNonlin, GastroPlus, SimCYP, NONMEM, Monolix and/or other modeling software is highly desired.
- Current knowledge of FDA regulatory guidance related to clinical pharmacology; experience having direct interaction with FDA, including submission of IND, NDA and other regulatory documents is required.
- Clinical pharmacology experience with small molecules in the area of oncology
- Excellent written and oral communication skills and ability to convey complex PK and PK/PD analysis methodology and outcomes to internal and external stakeholders.
- Direct experience in vendor management is required.
- Excellent verbal and written communication and organizational skills required with demonstrated success in leading projects and interacting with cross functional teams
- Ability to navigate, problem-solve, execute, and lead in a dynamic, fast-paced and evolving environment
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