Associate/Director, Clinical Pharmacology Modeling & Simulation (CPMS) - Remote
Company: PAREXEL
Location: Bolingbrook
Posted on: June 18, 2022
|
|
Job Description:
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.
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 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..
Employment in the US is contingent on disclosure of your COVID-19
vaccination status and, if relevant, proof of vaccination. EEO
Disclaimer Parexel 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.
Keywords: PAREXEL, Bolingbrook , Associate/Director, Clinical Pharmacology Modeling & Simulation (CPMS) - Remote, Healthcare , Bolingbrook, Illinois
Click
here to apply!
|