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Associate Director, Clinical Project Scientist

Company: Integrated Resources, Inc.
Location: Somerville
Posted on: September 22, 2022

Job Description:

Job Description
Associate Director, Clinical Project Scientist POSITION SUMMARY: The Clinical Project Scientist is a responsible member of a clinical team dedicated to the development and execution of clinical strategies and the clinical and operational implementation of a complex compound program. The Clinical Project Scientist provides active scientific contribution to a cross-functional clinical team developing a molecular entity. The Clinical Project Scientist provides input to the clinical development plan, works on the development of the clinical trial protocol, clinical trial materials, and takes responsibility for coordinating completion of clinical study reports and supports preparation of relevant documents for regulatory filings. This role involves extensive team matrix interactions with colleagues from a number of different disciplines. The Clinical Project Scientist may be asked to contribute to the evaluation of scientific opportunities in the therapeutic area. ESSENTIAL FUNCTIONS: Supports preparation of clinical development plans, trial protocols, and supports the operations group with trial set up and monitoring and assists with completion of clinical study reports Assists Physicians in evaluation of adverse events (pre and post-marketing) for relationship to treatment and supports the interpretation and reporting of results Assists Regulatory Affairs in determining requirements for any corrective actions or health authority reporting Interprets, reports and prepares oral and written results of product research, in concert with senior clinical personnel, in preparation for health authority submissions Responsible for data review in conjunction with other clinical team members OTHER RESPONSIBILITIES / DETAILED DUTIES: Assists Regulatory Affairs in the development of drug regulatory strategies Participate on and may lead cross-functional teams for evaluation of new product ideas, implement franchise business strategies, etc. Reviews medical literature and related new technologies May be asked to lead the execution of contracts May be asked to assess medical publications emerging from the team and its affiliates May be responsible, with appropriate colleagues, for review of Company advertising and promotion Education and Experience: A minimum of a Bachelor's degree is required. An advanced degree (e.g., MS, RN, RD, PhD or PharmD) is preferred. A minimum of at least 6 years of clinical research and development experience within the pharmaceutical industry is required. Required Technical Knowledge and Skills: Experience in cardiovascular, metabolic and/or retinal product development and cross company alliances is preferred Significant experience with managing/ supervising clinical trials, clinical research programs is required Strong interpersonal and communication skills are essential

Keywords: Integrated Resources, Inc., Somerville , Associate Director, Clinical Project Scientist, Executive , Somerville, Massachusetts

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