PK Director

Parexel is one of the only CROs to provide a broad depth of Clinical Pharmacology, Modeling and Simulation (CPMS) expertise to our clients, and the group is growing its capabilities and expanding globally! 

We currently have a tremendous opportunity available to join this extremely collaborative and super friendly team!  If you’re looking for an opportunity to expand professionally, do more than a narrow scope of work, work alongside a large team of CPMS experts, and provide solutions to a variety of clients with various products in different stages of development across multiple therapeutic areas, we would love to connect! 

We are currently seeking a highly experienced and highly innovative Director, Clinical Pharmacology Modeling and Simulation (CPMS) to join our team and help our clients reduce the time to bring new treatments to patients. 

The Scientific Director provides leadership to ensure the strategic application of Clinical Pharmacokinetic (PK), Pharmacodynamic (PD), and Modeling & Simulation (MS) principles towards efficient drug development. They contribute to the strategic direction and goals of the function and may champion or lead department objectives/initiatives. The Scientific Director is recognized for and provides scientific leadership in CPMS, working closely with the client to develop and implement strategies to support drug discovery and development programs. The Scientific Director leads client projects and is accountable for end-to-end delivery and quality review of all client projects under their leadership. They provide guidance on development of new service lines and provide subject matter expertise to capability development projects within the department and across the integrated Parexel organization.

Key Accountabilities:

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

Qualifications:

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

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Knowledge And Experience

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

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Qualified candidates who are seeking full-time or part-time employment will be considered in any of the 41 countries where Parexel has operations.

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