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RESPONSIBILITIES

Directing Phase I through IIa and Mechanism of Action studies in humans for pharmaceutical products under development. This person will: Direct the activities of Clinical Scientists in the planning and execution of clinical trials, for determining the safety, antiviral activity, medical usefulness, and marketability of drug candidates, and data collection activities, as well as the interpretation, integration and reporting of findings.

Provide strategic input into translational medicine aspects of the drug discovery and clinical biomarker selection process and finally design, perform and medical monitor complex studies designed to understand drug interaction with molecular targets and the disease process through the use of clinical biomarkers and/or imaging.

This person will also be responsible for authoring Clinical Development Plans for early assets and providing input into the clinical pharmacology profiling for virology drugs, including, consult on the design and serve as medical monitor for drug-drug interaction, age and gender, renal and hepatic impairment, food effect, ADME and other classical clinical pharmacology studies in healthy subjects.

Other responsibilities will include leading matrix teams focused on the development of clinical assets, serving as a medical scientific expert to marketing or research project teams and preparing new drug application and coordinating the writing and publishing of reports submitted to the FDA, with lead responsibility for content of pertinent sections.

OTHER MANAGEMENT EXPERIENCE PREFERENCES: Experience developing relationships with a network of key individuals from various departments important to job function, and experience interacting with key academic investigators in the fields of HIV and/or viral hepatitis, as well as site investigators. Experience and demonstrated success in leading matrix teams; ability to navigate strategic business alliances is a plus.

PREFERENCES: Experience in clinical medicine, and translational medicine and or bench research and monitoring for safety in a clinical or pharmaceutical company setting.

REQUIREMENTS

Board Certified or Eligible MD or MD, PhD with subspecialty medical expertise in infectious diseases, preferable HIV and or viral hepatitis.
3 to 5 years clinical experience gained through industry experience

Desired Management Experience:

Developing relationships with a network of individuals from various departments important to job function
Experience interacting with key academic investigators in the fields of HIV and/or viral hepatitis, as well as site investigators
Experience and demonstrated success in leading matrix teams; ability to navigate strategic business alliances a plus
Training and knowledge of bench research and/or investigative medicine/biomarker approaches applicable to HIV and/or viral hepatitis drug development
Knowledge of clinical pharmacology principles, and working knowledge of pharmacokinetics and exposure-response concepts
Therapeutic area expertise in HIV and/or viral hepatitis medicine. Expertise in the immunobiology of HIV and/or viral hepatitis a plus.
Experience in clinical medicine and monitoring for safety in a clinical or Pharmaceutical Company setting
Excellent written and verbal communication skills

Desired Functional Experience:

Training and knowledge of bench research and/or investigative medicine/biomarker approaches applicable to HIV and/or viral hepatitis drug development
Knowledge of clinical pharmacology principles, and working knowledge of pharmacokinetics and exposure-response concepts

LOCALE

Trenton, NJ

HOW TO APPLY

To apply for this position, copy/paste the following URL into your browser: http://ars2.equest.com/?response_id=90aaa8a7f2a0de0463299b9a1c894dbc

Discussion forums: Opportunity: Medical Director, Virology (#1000375) @ Bristol-Myers Squibb--Trenton, NJ (US)

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