US-MA: Boston-SR/EXECUTIVE MEDICAL DIRECTOR-ONCOLOGY
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Job Title: SR/EXECUTIVE MEDICAL DIRECTOR-ONCOLOGY
Job Location: MA: Boston
Pay Rate: competitive
Job Length: full time
Start Date: 2011-02-15
Company Name: The Judge Group, Inc.
Contact: Mike Hauschild
Phone: email only
Fax: email only
Description: The primary responsibilities of this position include the Strategic Planning and Clinical Support for Development Programs in Oncology. Essential Functions Development of clinical research programs in a variety of Oncology indications from Phase I to IV, leading to submission, regulatory approval and commercial success in the US and rest of the world.
Medical Director accountable for the design and medical supervision of clinical trials supporting the research program strategy including preparation and review of written documents: Clinical Trial Protocols, Case Report Forms, Clinical Study Reports, and providing medical leadership to the study operations teams.
Close collaboration with Drug Safety, Regulatory, Clinical Operations, New Products Planning, Discovery, Early Drug Development and other disciplines.
Preparation of documents for submission to regulatory authorities (Meeting Packages, Investigational Drug Applications [IND], NDAs, clinical components of other regulatory correspondence)
Participation as clinical expert in the evaluation of early discovery compounds or early stage external assets for their potential to be successful candidates for development
Clinical support for the evaluation of potential early and late stage licensing opportunities.
Interactions with key opinion leaders, and the ability to leverage these contacts to support organizational goals. Minimum education requirements MD Experience required 7 - 10 Years Knowledge and skills (general and technical) Education level and/or relevant experience(s):
Physician with Board Certification in Oncology, Hematology, and/or Immunology or other relevant field and at least 7 years (preferably 10-15) of pharmaceutical industry experience with Oncology therapeutic focus. MD/PhD preferred.
The desired individual will have exceptional clinical insight and translational medicine experience. Level of experience will determine initial level of responsibility. Experience with biologics, vaccines, and innate immune system compounds/modifiers is ideal.
Experience A proven track record of academic achievement and successful involvement in Oncology research. Thorough and up-to-date knowledge of therapeutic area including trends, advances, understanding of currently available therapies and competitive clinical landscape. Experience with working in clinical project teams, especially protocol development and trial initiation. Furthermore, the candidate must show that he/she is able to analyze and synthesize clinical data and has a thorough understanding of the requirements of the regulatory process. Expertise in implementing Oncology development programs in the US required.
Job ID: 329610
Please refer to Job code 329610 when responding to this ad.
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