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.