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    Senior Director of Enterprise Operations Strategic Planning

    Apex Systems
    Cambridge, MA 02138
    Full-time, Part-time
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    Job Description

    Company: Apex Systems
    Location: Cambridge
    Posted on: August 2, 2020

    Job Description:

    Senior Medical Director, Oncology, 1057646 Job Scope Purpose Ourestablished, long-term client is seeking a motivated SeniorMedicalDirector to be a key component in the drug development efforts of agrowing oncology company. Successful candidates will work within ahighly collaborative team environment to assist in developing andimplementing operational plans designed to meet project timelinesand the company's business objectives. Primary Job ResponsibilitiesAct as global medical monitor for assigned clinical trials Overseeall medical and scientific aspects of assigned clinical trials,including identifying study sites, reviewing of eligibility data,reviewing patient profiles (safety and efficacy) on an ongoingbasis, reviewing query generation, working closely with global ClinOps, Data Management, Medical Writing, etc. Direct protocolimplementation, including site identification and communication,attend investigators' meetings, correspond with sites includingIRBs, and interact with operations teams. Collaborate with globalteam members (e.g., Clin Ops, PVG, Stats, Data Management, MedicalWriting, etc.) on trial execution Provide medical expertise in thedevelopment, 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 alltablesplots, prepared or designed by Department of Biostatisticsfor clinical statistical analysis Lead the review, analysis andinterpretation of study data Support data analysis and assembly,including clinical study report writing, contribution to thepreparation of abstracts, presentations, and manuscripts.Responsibility for medical assessment, medical review, signaldetection and health hazard evaluation activities Serve as contentowner for assigned clinical trial and other documents whereclinicalmedical is identified as the content owner Conduct protocoldevelopment to include working closely with medical writing andproject teams. Write the clinical sections and review of allclinical documents related to the assigned clinical studies (e.g.,study protocols and study reports), as well as contributing torelated study documents, e.g., Investigator Brochure Participate inprogram development, including working cross-functionally with allof the disciplines necessary for successful drug developmentpre-clinical, manufacturing, quality assurance, regulatory, medicalaffairs, marketing, legal, biostatistics and data management,pharmacovigilence, and clinical operations. Interact closely withthe pre-clinical team, to understand the scientific basis oftargeted therapy, and to apply this knowledge to articulatingtherapeutic strategies and comprehending biomarker exploration.Demonstrate independence, initiative and the ability to thrive in afast-paced environment. Travel time is approximately 20 includingvisits to investigative sites, regulatory agencies, and attendanceat major oncology meetings. Primary Job Requirements M.D. withboard certification in Oncology or HematologyOncology. Experiencein clinical trials and drug development are preferred. Minimum 3years of pharmaceutical industry experience with 1 years of thosein OncologyHematology About Stratacuity Whether you are seeking acareer change or simply interested in becoming part of our network,you will appreciate the ethics guiding each Stratacuity teammember. We build lasting relationships with exceptionalbiopharmaceutical talent and take great care to protect yourpersonal information. Upon receiving your inquiry, you may bedirectly contacted by a Stratacuity team member to discuss yourcareer goals. We will not share your information with anyonewithout your direct prior consent. PROVEN SCIENTIFICPLACEMENTTrademark Stratacuity is an Equal EmploymentOpportunityAffirmative Action Employer. All qualified applicantswill receive consideration for employment without regard to race,color, religion, sex, age, sexual orientation, gender identity,national origin, disability, protected veteran status, or any othercharacteristic protected by law. Stratacuity will considerqualified applicants with criminal histories in a manner consistentwith the requirements of applicable law. If you have visited ourwebsite in search of information on employment opportunities or toapply for a position, and you require an accommodation in using ourwebsite for a search or application, please contact us.jpricestratacuity.com Code ClinOps EEO Employer Apex Systems is anequal opportunity employer. We do not discriminate or allowdiscrimination on the basis of race, color, religion, creed, sex(including pregnancy, childbirth, breastfeeding, or related medicalconditions), age, sexual orientation, gender identity, nationalorigin, ancestry, citizenship, genetic information, registereddomestic partner status, marital status, disability, status as acrime victim, protected veteran status, political affiliation,union membership, or any other characteristic protected by law.Apex will consider qualified applicants with criminal histories ina manner consistent with the requirements of applicable law. If youhave visited our website in search of information on employmentopportunities or to apply for a position, and you require anaccommodation in using our website for a search or application,please contact our Employee Services Department atemployeeservicesapexsystemsinc.com or 844-463-6178.SDL2017

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

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