Clinical Pharmacology / PK Director - flexible work location

Parexel is one of the only CROs to provide a broad depth of Clinical Pharmacology, Modeling and Simulation expertise to our clients, and the group is currently seeking an intellectually curious and highly innovative Clinical Pharmacology / PK Director to bring their high-level of motivation to our team and help our clients reduce the time to bring new treatments to patients.

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, provide solutions to a variety of clients with various products in different stages of development across multiple therapeutic areas, and join an extremely collaborative and super friendly team, we would love to connect!

Accountability

* To analyze clinical PK/PD data as a member of several multidisciplinary development program teams.

* To work with clinical team to design PK/PD components in various study designs such as first-in-human, bioequivalence and drug-drug interaction studies.

* Responsible for authoring or contributing to clinical PK/PD sections of relevant documents.

* 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 of scientific documentation including Clinical Study Protocols, SOPs, Statistical Analysis Plans and Clinical Study Reports

* Provides Quality Control (QC) for WinNonlin and NONMEM analysis

* Review of derived PK/PD data generated by PK Analyst

* Maintaining a strong working knowledge of pharmacology, biology, therapeutics, drug metabolism, bioanalysis, and biopharmaceutics

* Developing and maintaining a relationship with internal and external clients and scientists

* Undertake the full range of duties relevant to the leadership, management and development of the team to ensure their performance meets and or exceeds both the business and their own personal goals/objectives

* Maintain a positive, results orientated work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced and objective manner

* Participate in formal staff review processes e.g. performance and salary reviews to corporate standards and timescales.

* To provide training and scientific support and advice to relevant Parexel staff

* Provide training and guidance and act as a mentor to less experienced departmental members

* To attend client meetings and represent Quantitative Clinical Pharmacology aspects as needed

* Reviewing/Authoring scientific publications, abstracts, posters

Qualifications:

• Excellent written and verbal English communication skills are required. Chinese language skills are a plus.

• Advanced science degree (PhD, PharmD, MSc) and/or relevant experienceStrong knowledge of PK and PD principles

• Significant experience in scientific documentation writing including Clinical Study Protocols, SOPs, Statistical Analysis Plans and Clinical Study Reports

• 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 analysis.

• Strong non-compartmental analysis experience.

• 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 in drug development and clinical trial conduct in pharmaceutical industry, CRO or academia desired

• Acknowledged as an expert in the industry with at least 7-10 years of relevant experience.

• Demonstrated knowledge of regulatory environment as it relates to Clinical Pharmacology and Drug Development

Parexel Benefits:

• Health, Vision & Dental Insurance

• Tuition Reimbursement

• Vacation/Holiday/Sick Time

• Flexible Spending & Health Savings Accounts

• Work/Life Balance

• 401(k) with Company match

• Pet Insurance

At Parexel we embrace flexibility and understand that in today's fast-paced world, employees need to balance their careers with their personal lives. Come join us where learning is constant, you're exposed to a world of experiences and open doors.