Essential Functions:
- Develop and implement the CPP strategies across program, indication and study levels, including strategies for Phase I –III drug development and registration.
- Provide guidance in interpreting the data from pharmacometric analyses, including PPK, exposure-response analyses, and other quantitative analyses, to recommend dosing paradigm for different phases of clinical development; provide justification for dose selection for pivotal clinical trials.
- Liaise with biologists and preclinical scientists to come up with structural models for particular mechanisms as applies to clinical development; collaborate with BioStats, Data Management, Clinical Operations & Medical to support development projects.
- Generate reports for NCA PK, population PK and exposure-response analyses, author (s)NDA/(s)BLA summary dossiers, contribute to background document sent to regulatory authorities to support milestone meetings (e.g EOP2).
- Present data and recommendations to global program teams, external collaborators and senior management.
- May lead and manage a team of clinical pharmacologists with diverse background and experiences.
- Serve as a leader supporting the overall CPP and/or translational medicine organizational objectives
- Stay current with scientific advancements and regulatory trends in clinical pharmacology and Pharmacometrics, and apply the knowledge to advance drug discovery and development for the organization;
- Publish in peer reviewed journals.
Qualifications (Minimal acceptable level of education, work experience, and competency):
- Ph.D. or MD with 10-15 years or more of experience in appropriate disciplines that lay the foundation for the job functions detailed above;
- Prior successful experiences in global regulatory interactions, including IND, EOP1/2, RTOR/AA, scientific advice and successful approvals;
- Proven experience in leading and managing sophisticated and quantitative scientific teams;
- Excellent communication skills and ability to effectively collaborate with cross-functional teams and influence decision-making process;
- Preferred hands on experience with PPK, ER or PBPK analyses and reporting, and experience using NONMEM, R, SimCYP or GastroPlus, or other programs.
- Strength in delivering results on agreed timelines in advancing pipeline
- Experience working in a matrix environment.
- Appropriate publication record in top-tier and peer-reviewed journals is required to establish credibility with a highly talented scientific team.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
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