Director of Clinical Pharmacology

Director Clinical Pharmacology Description We are searching for a motivated individual to participate in the discovery and development of small molecule and biologic derived drugs; this individual will represent the clinical pharmacology function in the following activities: design, analysis and interpretation of clinical pharmacokinetic and pharmacodynamic studies; characterization of drug disposition, optimize dosing strategies, assessment of drug-drug interactions; and conduct of non-compartmental and compartmental analysis of clinical data. The candidate must have experience in evaluating the clinical pharmacology of special populations, such as pediatrics, patients with hepatic and renal failure, individuals with PGx variations in drug-metabolizing enzymes, etc.The individual must be able to operate in a matrix team environment and to independently provide clinical pharmacology expertise for development teams. Key to job success will be developing strong working relationships with constituents and strong leadership. As an important contributor to clinical strategy development, the individual will need to be comfortable making presentations to internal scientific staff, management & external collaborators and possess solid writing skills. The candidate should have experience in participating in US and ex-US regulatory activities. A solid knowledge of clinical pharmacokinetics; the ability to prepare regulatory filings and communications with regulatory agencies; proficiency with WinNonlin, NONMEM or similar programs; and experience with small and large molecule discovery and development issues are necessary. Specific responsibilities: Primary accountability and responsibility for the clinical pharmacology deliverables on assigned projects including: non-compartmental/compartmental analysis of PK data and appropriate PK-PD analysis including population PK and PK-PD modeling and simulation; contributions to all key documents and activities including Investigator Brochures, TTP, EOP2 meetings, NDA/MAA/ANDA, and post-approval filings; resolution of clinical pharmacology queries from drug regulatory agencies. Contribute to/lead planning of studies that generate PK-PD data and conduct analyses that integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics and disease states to optimize doses, dosage regimens and study designs throughout clinical drug development. PhD, MD or PharmD with 7-10 years of experience If interested please reply with your CV to [email protected] or contact me.