Vice President Of Clinical Strategy Commercial Assessment in Somerset
: $177,070.00 - $177,070.00 /year *
: Executive Management
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Vice President Of Clinical Strategy Commercial Assessment - RCM TechnologiesReference :19-01196Title :Vice President of Clinical Strategy & Commercial AssessmentLocation :Basking Ridge, NJPosition Type :Direct PlacementExperience Level :11 YearsStart Date :09/19/2019 DescriptionRCM Technologies is a leading provider of IT Business Solutions and Engineering Services to over 1,000 clients in the commercial and government sectors. RCM partners with clients to define implement and manage a broad range of technologies across multiple platforms, systems, and networks. Our broad geographic presence ensures that a proven and reliable tactical and strategic capability is available and deployable virtually everywhere in North America.Our client is seeking a Vice President of Clinical Strategy & Commercial Assessment The Vice President of clinical strategy and commercial assessment will manage the scientific, clinical and medical affairs activities across therapeutic development programs and manage the commercial assessment of development programs. Responsibilities: Clinical Development Program Level Manage and/or support cross-functional team in development, review and finalization of clinical development plan With Regulatory, co-lead TPP development and maintenance Clinical Study Design Manage protocol development, review and finalization Manage IB development, review and finalization Contribute to study-related documents including ICF, CRF, charters, etc and ensure consistency across study documents Work with medical director and biostatistician in development of SAP Clinical Study Conduct Along with clinical study team, participate in periodic data listing and table reviews to ensure collection of high quality data Work with medical director and biostatistician to develop TLFs for CSR Clinical Study Completion Manage CSR development, review and finalization For BLA submissions, manage development, review and finalization of clinical components of CTD including integrated summaries of safety and efficacy, clinical summaries of safety and efficacy and clinical overviews of safety and efficacy Regulatory submissions Contribute to clinical sections of regulatory documents including responses, briefing books, etc Medical Communications/Affairs Publication Planning Manage cross-functional team in development of publication strategy including abstracts, posters, presentations and manuscripts for clinical study and preclinical publications Manage and/or support the development of documents and slide decks for publication or presentation Develop and maintain slide libraries Investor/Business Development/Corporate Communications Manage development and review of scientific content included in external facing materials for investor and Client audiences Review press releases to ensure accuracy and contribute to positioning of information KOL Engagement Work with medical director and therapeutic teams on strategic and tactical execution of advisory board meetings and other KOL engagement activities Clinical Program/Disease State Awareness & Education Manage external vendors and cross-functional internal team to develop high-impact DSE programs to support commercial launch Conduct periodic literature landscaping Manage external educational efforts for ongoing clinical programs Medical Affairs Function Planning Develop plans and begin building Medical Affairs function and capabilities Product Commercial Assessment and Brand Development Competitive Intelligence Research and compile data and information on competitors and provide point of view on relevance to therapeutic programs Commercial Assessments Manage cross-functional team and external vendors in commercial assessments of development programs Liaison between any third parties involved and internal finance group pertaining to the preparation of financial models, NPV calculations and revenue forecasts. Prepare materials and participate as needed in portfolio reviews and prioritization Commercial Readiness ?Support and manage cross-functional team as needed on work streams enabling commercial launch of products in development ?With Regulatory and Marketing, develop product label strategy and content Branding Development Products Manage external vendors and cross-functional internal team in development of product brand names Knowledge & Experience: Must have PhD or equivalent experience Must have 10-15 years of industry experience working in clinical development, including clinical study design, periodic review of data tables to ensure high quality data and review and finalization of clinical data showing safety and efficacy Must also have industry experience leading medical affairs and medical communication to external investors, key opinion leaders and cross functional teams for delivering DSE programs. Must be able to start up a medical affairs function and define capabilities. Will be responsible for commercial assessment and brand development to include leading both cross functional teams and external vendors in assessing development programs, NP by Jobble Associated topics: diet, drug development, histotechnologist, immunology, nephrology, nutritionist, patient, pharmacology, therapy, vaccine
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.