US-NJ – Associate Director – Clinical Pharmacology
In this role, the individual will have the responsibility to lead the clinical pharmacology
development of Cardiovascular and Metabolic Disease programs in full development and life cycle
management, and to contribute to the design, planning, execution and interpretation of studies
conducted in early clinical development, particularly results of human clinical trials in phases I to
II of development. This individual will manage the clinical pharmacology profiling for
cardiovascular and metabolic disease drugs with both small molecules and biologics. The
individual will act as study director for the following types of clinical studies in healthy volunteers
or patients: drug-drug interaction; biopharmaceutics such as BA/BE and food effect; special
population studies (renal, hepatic); ADME; thorough QT; and biocomparability studies. The
individual will be responsible for the creation and design of the Clinical Pharmacology plan in full
development and life cycle management and contribute to the Clinical Pharmacology aspects in
early clinical development. The individual will manage the clinical study process from protocol
development to final study report through regulatory dossier production, prepare protocols and
conduct clinical studies of products that have been determined to satisfy a medical need and
offer a commercial potential, and to serve as a clinical pharmacology expert across the
organization and to government regulatory agencies. The individual will be responsible for the
preparation of the Clinical Pharmacology components of regulatory submissions and responding
to regulatory authority questions. The individual will represent the department at the
development matrix team level to ensure integration of the Clinical Pharmacology plan with the
global development plan.
Requirements for the position include a Ph.D. in pharmacology or pharmacokinetics or a PharmD
with a clinical pharmacology research fellowship. A minimum of 4 years experience gained
through direct industry experience in Clinical Pharmacology would be preferred. Experience in
being a Study Director contributing to the pharmacokinetic and pharmacodynamic aspects of
clinical protocol design, writing, data interpretation, review and reporting of results for multiple
studies of different types for multiple projects in the Cardiovascular or Metabolic Disease areas is
desired. Experience with biologics is desirable. Must have experience developing at least one or
more clinical pharmacology plans. Demonstrated experience in preparing regulatory submissions,
including full NDAs or significant sNDAs, as well as multiple INDs. Experience responding to
regulatory questions related to pharmacokinetics and pharmacodynamics. Application and
knowledge of current practices and issues in the following areas for multiple projects clinical
pharmacology, bioanalytical, biopharmaceutics, regulatory, non clinical metabolism and
pharmacokinetics, pharmacology, and toxicology. Knowledge of modeling and simulation
techniques and related data interpretation on multiple projects is desirable. Proven leadership
skills working in a highly matrixed organization with a successful track record as a direct
supervisor, mentor and developer of people. Strong communication and project management
skills required. Our client is a leading pharmaceutical company with research facilities in New
Jersey and can provide excellent benefits (health insurance, dental, and vision plan, paid vacation
and more). A high impact, high profile position. All interested parties should contact Dan Kane
by phone at 732-316-1911 Ext. 218 or
E-Mail to shanes@neurosearch.org
Dan Kane
NeuroSearch
a division of Diedre Moire Corporation, Inc.
3145 Bordentown Avenue
Suite H
Parlin, NJ 08859
Voice: 732-316-1911 Ext 218
Fax: 609-981-9967
Email: shanes@neurosearch.org