Associate/Director, Clinical Pharmacology Modeling & Simulation (CPMS)

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 TWO tremendous opportunities 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) and an Associate Director, CPMS to join our team and help our clients reduce the time to bring new treatments to patients.

The Scientific Associate/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. Analyze clinical PK/PD data as a member of several multidisciplinary development program 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. Serve as a primary source of scientific support for the design, analysis, reporting, and presentation of sophisticated PK/PD modeling and simulation initiatives, including population PK/PD analyses for all phases of development Review/author scientific documentation including Clinical Study Protocols, SOPs, Statistical Analysis Plans and Clinical Study Reports, regulatory responses and submissions and publications for peer review journals Maintain a strong working knowledge of pharmacology, biology, therapeutics, drug metabolism, bioanalysis, and biopharmaceutics Develop and maintain a relationship with internal and external clients and scientists Responsible for the strategic and operational delivery of client programs and projects to timelines, quality expectations and regulatory requirements. Provide subject matter expertise to internal Parexel teams as needed Initiate and contribute to department and cross-BU improvement and training initiatives. Identify, quantify and as appropriate mitigate risks within the team driving business continuity and quality Initiate and maintain scientific and consultative relationships with clients contributing to strategy of client programs in CPMS Identify and follow through new business opportunities Promote CPMS capability across Parexel to optimize integration in company and client initiatives. Accountable for the Customer Satisfaction Works with Marketing in the preparation and participation of webinars, symposiums, industry conferences, articles and white papers, etc. QualificationsReview and lead preparation of Request for Information (RFI) and Request for Proposal (RFP) for potential clients Actively support the leadership and development of the team to ensure their performance meets and or exceeds both the business and their own personal goals/objectives Provide training and scientific support and advice to relevant Parexel colleagues Act as a mentor to less experienced departmental members Maintain a positive, results orientated work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced and objective manner Qualifications: At least 4 years of relevant experience for an Associate Director level role and 5-6+ years for a Director level role Strong knowledge of PK and PD principles Strong experience with the design and implementation of Model-Based Drug Development strategies Expertise with Pharmacometric methodologies (e.g., disease modelling, conc-QT analysis, clinical trial simulation) Strong experience non-compartmental analysis Experience in Pharsight Software (PKS/WinNonlin/Phoenix) Experience in other software such as NONMEM, GastroPlus and R is desirable Significant experience in clinical drug development of both NCEs and biologicals 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 Education

Advanced science degree (PhD, PharmD) and/or relevant experience

Employment is contingent on disclosure of your COVID-19 vaccination status and, if relevant, proof of vaccination.EEO DisclaimerParexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.