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PK Director

Employer
Parexel - USA
Location
United States
Salary
Competitive
Start date
14 Sep 2022
Closing date
14 Oct 2022

View more

Discipline
Medical Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
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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 atremendous 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



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



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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