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VP/Sr./Medical Director - Oncology

Company: Apex Systems
Location: Cambridge
Posted on: September 15, 2020

Job Description:

Senior Medical Director, Oncology, 1057646 Job Scope Purpose Our established, long-term client is seeking a motivated SeniorMedical Director to be a key component in the drug development efforts of a growing oncology company. Successful candidates will work within a highly collaborative team environment to assist in developing and implementing operational plans designed to meet project timelines and the company''s business objectives. Primary Job Responsibilities Act as global medical monitor for assigned clinical trials Oversee all medical and scientific aspects of assigned clinical trials, including identifying study sites, reviewing of eligibility data, reviewing patient profiles (safety and efficacy) on an ongoing basis, reviewing query generation, working closely with global Clin Ops, Data Management, Medical Writing, etc. Direct protocol implementation, including site identification and communication, attend investigators'' meetings, correspond with sites including IRBs, and interact with operations teams. Collaborate with global team members (e.g., Clin Ops, PVG, Stats, Data Management, Medical Writing, etc.) on trial execution Provide medical expertise in the development, review and approval of Case Report Form (CRF) design, Informed Consent Form (ICF) design, site source documents, etc. Review and approve Statistical Analysis Plans (SAPs) and all tablesplots, prepared or designed by Department of Biostatistics for clinical statistical analysis Lead the review, analysis and interpretation of study data Support data analysis and assembly, including clinical study report writing, contribution to the preparation of abstracts, presentations, and manuscripts. Responsibility for medical assessment, medical review, signal detection and health hazard evaluation activities Serve as content owner for assigned clinical trial and other documents where clinicalmedical is identified as the content owner Conduct protocol development to include working closely with medical writing and project teams. Write the clinical sections and review of all clinical documents related to the assigned clinical studies (e.g., study protocols and study reports), as well as contributing to related study documents, e.g., Investigator Brochure Participate in program development, including working cross-functionally with all of the disciplines necessary for successful drug development pre-clinical, manufacturing, quality assurance, regulatory, medical affairs, marketing, legal, biostatistics and data management, pharmacovigilence, and clinical operations. Interact closely with the pre-clinical team, to understand the scientific basis of targeted therapy, and to apply this knowledge to articulating therapeutic strategies and comprehending biomarker exploration. Demonstrate independence, initiative and the ability to thrive in a fast-paced environment. Travel time is approximately 20 including visits to investigative sites, regulatory agencies, and attendance at major oncology meetings. Primary Job Requirements M.D. with board certification in Oncology or HematologyOncology. Experience in clinical trials and drug development are preferred. Minimum 3 years of pharmaceutical industry experience with 1 years of those in OncologyHematology About Stratacuity Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent. PROVEN SCIENTIFIC PLACEMENTTrademark Stratacuity is an Equal Employment OpportunityAffirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us. Code ClinOps EEO Employer Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at orby Jobble

Keywords: Apex Systems, Cambridge , VP/Sr./Medical Director - Oncology, Executive , Cambridge, Massachusetts

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