Primary Responsibilities Summary:
The Director of Clinical Research reports to US Medical Lead Physician for Cardiovascular Emerging Brands, and provides medical input to all aspects of product development. Duties:- Deployed to the Emerging CV team with focus on new chemical entities in the Cardiovascular/Atherosclerosis/Metabolism global product team.- Serves as a source of medical expertise for product teams and provides input to decisions of the Therapy Area that may have medical and scientific and marketing implications relative to his/her expertise.- Responsible (in collaboration with other Product Team members) for the medical input to design, planning, initiation and completion of clinical trials of these and other compound early phase compounds.- Responsible for the preparation of medical components of Product Plans, the medical components of study protocols, IND, and other FDA communications under the direction of the US Medical Lead Physician and the Cardiovascular Clinical Section Director.
Responsible to establish communications with prominent clinical investigators in his/her particular field of expertise, particularly those who will be willing and able to assist in the evaluation of company's products in accordance with Product Team objectives.- Attends appropriate scientific meetings to maintain his/her awareness of research activities in his/her area of expertise.- Applies strategic intent of company when working with FDA, opinion leaders, prescribers and consumers of company products.- Performs product safety medical reviews for assigned investigational and marketed products as designated by the Clinical Science Director.- Provides medical and specialty expertise for safety surveillance of assigned company investigational products.- Ensures an appropriate level of customer service to internal and external customers.- Assumes other duties as assigned by the US Medical Lead Physician, Cardiovascular Clinical Section Director, and Vice President, Medicine and Science Internal and External Contacts/Customers:- -
Works with internal
and external customers, including Clinical Project Teams, Global Product
Teams, Therapy Areas, Global Marketing and Business Development,
Regulatory, and FDA (including DDMAC) to accomplish tasks related to the
product development, to improve clinical development processes, and to
insure satisfaction of these customers.
Minimum Requirements:- Graduate of a recognized school of medicine with an M.D. degree or equivalent.- Specialty training and board certification or eligibility in Internal Medicine, Endocrinology, Nephrology, Cardiovascular Medicine, or Diabetes Care- Background in clinical research.- Familiarity with biostatistics.- Excellent written and oral communication/presentation, social/interpersonal, and organizational skills.- Ability to travel nationally and internationally.- Strong team player skills and ability to work in a global pharmaceutical environment-
Ability to balance business and clinical research objectives Preferred Background:- Board certification in Internal Medicine, and ideally, board certification in relevant discipline (Endocrine, Nephrology, Cardiovascular Medicine) or significant history of working in the Diabetes field- Prior academic career in Endocrine, Nephrology, Cardiology, or Internal Medicine with clinical experience and research track record in cardiovascular or metabolic disease
- At least two years experience in industry designing
and implementing clinical trials and interpreting trial results. Ideally,
experience in diabetes and/or dyslipidemia drug development obtained while
working in the industry.
Knowledge of CDER regulations regarding evaluation and approval of pharmaceuticals (required for Director).- An understanding of US pharmaceutical safety reporting and surveillance (required for Director).- Respected by peer for therapeutic area expertise
Qualified candidates please forward by email cover letter outlining compensation, geographical preferences, availability and a professional resume in complete confidence to: Frank Sinclaire - Health Care Division Group Manager, fsinclaire@pailingroup.com
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