Director, Clinical Pharmacology Modeling and Simulation (CPMS) job in Boise, USA

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First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

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Are you an employer or a jobseeker?*

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Job type: Permanent

Discipline: Project/Study Manager (CSM/CPM), Program Manager / Director, Clinical Scientist

Location: United States

This vacancy has now expired. Please see similar roles below...

Proclinical is seeking a Director, Clinical Pharmacology Modeling and Simulation (CPMS) for a leading CRO located in the US. This position will provide leadership to ensure the strategic application of Clinical Pharmacokinetic (PK), Pharmacodynamic (PD), and Modeling & Simulation (MS) principles towards efficient drug development.

Must be eligible to work or be a citizen in the US.

Job Responsibility:

Serve as a primary source of scientific support for the design, analysis, reporting, and presentation of PK data from clinical trials covering all phases of drug development
Analyze clinical PK data as a member of multidisciplinary development teams.
Work with clinical teams to design PK/PD components in various study designs such as first-in-human, Proof of Concept, Phase 2B, bioequivalence and drug-drug interaction studies.
Responsible for the strategic and operational delivery of client programs and projects to timelines, quality expectations and regulatory requirements.
Act as a mentor to less experienced departmental members

Skills and Requirements:

Depth of experience and relevant experience will determine level of role, Associate Director level role or Director level
Excellent written and verbal English communication skills are required. Chinese language skills are a plus
Advanced science degree (PhD, PharmD, MSc) and/or relevant experience
Significant experience in clinical drug development of both NCEs and biologicals
Demonstrated understanding of the drug development process and a broad knowledge of FDA and EMEA guidelines, as well as global regulatory expectations
Experience using Phoenix WinNonlin to conduct non-compartmental and compartmental analysis
Experience using other software such as NONMEM, GastroPlus or R are desirable
Strong non-compartmental analysis experience
Previous popPK and/or PBPK experience are a plus
Excellent interpersonal, verbal and written communication skills
Extensive clinical/scientific writing skills
Client focused approach to work ethic
Exhibits and promotes a flexible attitude with respect to work assignments and new learning
Ability to direct and manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
Willingness to work in a matrix environment and to value and promote the importance of teamwork.
Demonstrated understanding of the drug development process and a broad knowledge of FDA and EMEA guidelines, as well as global regulatory expectations
Significant experience with application of clinical pharmacology, modeling and simulation in drug development and clinical trial conduct in pharmaceutical industry, CRO or academia desired
Acknowledged as an expert in the industry
Demonstrated knowledge of regulatory environment as it relates to CPMS and Drug Development

If you are having difficulty in applying or if you have any questions, please contact Julia Friedrich at (+1) 617-830-1584 or j.friedrich@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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