Key Accountabilities
- 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, b ioanalysis, and b iopharmaceutics
- 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.
- Drive embedding of LEAN concepts in process deployment and improvement
- 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.
- 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)
- 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
- 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
