Our Client is a leading commercial stage Biotechnology company with an exciting portfolio of clinical prospects addressing unmet need in Oncology, Immunology and Dermatology.
We are searching for an exceptional leader to play a crucial role in leading and overseeing the clinical pharmacology & pharmacometric activities within our client's organization. You will be responsible for providing strategic direction, scientific leadership, and collaborative working environment to advance the drug candidates from IND through Phase IV. This position will manage a team of direct reports, and collaborate with cross- functional stakeholders including in vitro & In vivo pharmacology, translational sciences, DMPK, clinical development and operations, regulatory, CMC, and medical affairs.
Essential Functions of the Job (Key responsibilities)
Provide strategic and scientific leadership in clinical pharmacology and pharmacometrics across portfolios;
Lead and manage a team of clinical pharmacologists with diverse background and experiences;
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 modeling, simulation and quantitative exposure-response analyses to recommend dosing paradigm for different phases of clinical development; provide justification for dose selection for pivotal clinical trials.
Responsible for some specific exposure-response analyses, e.g. QTc, effect of renal and hepatic dysfunction etc.
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 section 2.7.2 of NDA, contribute to background packages sent to regulatory authorities to support milestone meetings (e.g EOP2).
Present data and recommendations to project teams, external collaborators and senior management.
Stay front of 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-years of experiences in an appropriate discipline that lays the foundation for the job functions detailed above;
Prior successful experiences in global regulatory interactions, including EOP1/2, RTOR/AA, scientific advices and successful approvals;
Proven experience in leading and managing 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 with experiences using NONMEM, or SAS, R, SimCYP or GastroPlus, or other programs.
Experience working in a matrix environment.
Appropriate publication record is desirable.
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