Medical Director- Pharma - PGxHealth a Division of Clinical Data

Position Description

Description
Clinical Data, Inc. (NASDAQ: CLDA), a provider of comprehensive molecular and pharmacogenomics services and clinical diagnostics to improve patient care, seeks a Medical Director with expertise in psychiatric/central nervous system diseases or cardiovascular diseases. Major responsibilities will include: medical/clinical expertise for development and commercialization of pharmacogenetic tests to guide medical therapy; participation on product development teams and in collaborations with academic centers of excellence to develop genetic biomarkers of drug response; and working closely with payors, providers, and key opinion leaders to assure the successful integration of pharmacogenetic tests in care management. This position reports to the Chief Medical Officer and is located in New Haven, CT.


ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
• Provide overall medical direction for development and utilization of pharmacogenetic tests, acting as the medical liaison to Product Evaluation and Development and Sales and Marketing. This individual will be expected to establish effective relationships across the company to represent medical and clinical concerns for both pre-market and post-market development programs.
• Present product concepts and development plans to, and work collaboratively with, payers, providers, and other collaborators.
• Build relationships with and manage key opinion leaders.
• Develop and present, with sales and marketing, publications, medical education and promotional materials.
• Participate in conferences and scientific meetings to maintain awareness of research and product activities and present at these conferences as requested.
• Responsible for the direction, planning, execution, and completion of clinical trials of new or marketed products and preparation of medical components of product plans, study protocols, and 510(k)/PMAs.
• Ensure, where indicated, that medical policies and protocols are in compliance with FDA and other regulatory agencies.
• Direct and/or manage the preparation of the clinical sections of regulatory submissions.
• Develop and manage clinical program budgets.

SUPERVISORY RESPONSIBILITIES
No current supervisory responsibilities. However, we anticipate growth of the Medical Affairs Group and the assumption of such responsibilities in the future.

Requirements .
M.D. or Ph.D. with at least 3 years clinical experience and 3 years of industry experience in clinical development of drugs and/or devices or in the evaluation of devices or drugs for payers, preferably in the areas of psychiatry or central nervous system disorders or cardiovascular disorders; an understanding of the applications of pharmacogenomics/pharmacogenetics is highly desirable; practical experience with the evaluation and approval of pharmaceuticals and/or devices would be a positive addition; proven ability to develop and implement innovative programs and processes.

EOE.

How to Apply

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