Director-Medical Doctor-Global Medical Monitor
Job Category: Biotech/R&D/Science Job Description:At Wyeth, we have a vision of leading the way to a healthier world. We've committed ourselves to achieving this vision by making quality, integrity and excellence the hallmarks of our business. A Fortune 500 company and global leader in pharmaceuticals, consumer healthcare, and animal healthcare products, we know that our employees are who keep us on the cutting edge of innovative discoveries and superior customer service. To sustain and enhance our leadership position in the pharmaceutical industry, we continue to recruit, develop and motivate individuals whose skills, values, and work ethic will grow and improve our business.Job SummaryThe Global Medical Monitor (GMM) is accountable for patient safety and provides medical guidance during study design and execution to support the development strategy of novel compounds for treatment of hematologic malignancies, including leukemia and lymphoma, as well as novel blood coagulation therapies.In addition to study level activities, the GMM will participate on Learn/Confirm Teams, participate in standing clinical research committees, review compounds for potential in-licensing including performance of due diligence reviews and provide assistance to New Business Development on Market Opportunity and Target Product Profile.The GMM also may be required to design a Development Strategy with multiple protocols designed to obtain world wide approval for a compound or group of compounds.Job ResponsibilitiesAccountable for safety across the study, Design protocol and strategy, Provide global medical input into country feasibility, Perform review of data generated by statistical analyses, Perform all reviews and procedures required for database lock, Audit response, Study closeout / inspection readiness, Participate in protocol and safety training, and other responsibilities as required.Basic QualificationsM.D.. degree and a minimum of 2 years of relevant pharmaceutical industry is required and subspecialty and certification in Hematology (or Oncology) is highly desirable.Experience is required with some or all of the following: Good Clinical Practice, ICF development, Adverse events and handling Serious Adverse Events, Study Design and Protocol Development, Data review, Clinical Study Report - preparation and review, Regulatory submissions - elements of required documents in eCTD, Medical and Safety expert, Skill in protocol design, interpretation, and medical conduct, Knowledge and understanding of patient populations, and therapeutic area knowledge or strong clinical development knowledge.Relocation is available for this position. Wyeth offers competitive compensation and benefits programs, including child-care subsidies, flex-time, business casual attire, educational assistance and professional development programs. For more information and to apply online, please visit us at: www.wyeth.com/careers Wyeth is an Equal Opportunity Employer, M/F/D/V. Search Firm Representatives: Please Read Carefully. Wyeth is not seeking assistance or accepting unsolicited resumes from search firms for this employment opportunity. Regardless of past practice, all resumes submitted by search firms to any employee at Wyeth via-email, the Internet or directly to hiring managers at Wyeth in any form without a valid written search agreement in place for that position will be deemed the sole property of Wyeth, and no fee will be paid in the event the candidate is hired by Wyeth as a result of the referral or through other means. Note: Any search agreement entered into with Wyeth prior to January 2004 is hereinafter void. Search firms are essential to the recruitment and staffing efforts at Wyeth and we value the partnerships we have built with our preferred vendors. For this reason, Wyeth has established and regularly maintains a preferred vendor list. Please note that even preferred vendors need to have a written search agreement signed by the Vice President, Strategic Staffing at Wyeth in place for the specific position in order for a fee to be paid for any candidate referrals.Job Experience:See above.Expected Travel Time: None Zip Code :US-MA-Cambridge Leading the way to a healthier world.
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