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Associate Director, RD

Company: Precision Molecular Inc
Location: Arlington
Posted on: November 21, 2020

Job Description:

Precision Molecular, Inc (PMI) is a clinical-stage company with the mission to develop imaging biomarkers and theranostics (targeted therapy combined with diagnostics) for management of patients with CNS disorders and cancer. PMI is advancing 5 PET imaging biomarker products in the clinic with great potential to improve early diagnostics of neurodegenerative diseases and cancer. Utilizing these imaging biomarkers to follow disease progression may provide clinical researchers with powerful tools for early assessment of drug efficacy in clinical trials.PMI is one of multiple subsidiaries of D&D Pharmatech, a clinical-stage global biotech company that funds the development of revolutionary medicines through disease-specific subsidiary companies founded and guided by top-tier medical research faculty and biotechnology veterans. This corporate structure creates a unique opportunity to accelerate translation of cutting-edge research into lifesaving therapeutic products for patients. We offer health benefits, 401k, and PTO. For more information about D&D Pharmatech and PMI, please visit Summary of Position This position will be a key member of a global multifunctional team and be responsible for supporting the development and commercialization of clinical phase PET radiopharmaceuticals. Key accountabilities will include setup of new Contract Research Organizations and academic centers that will provide GMP radiotracers for clinical studies, development of policies, processes, and procedures in support of clinical phase PET radiopharmaceutical manufacturing, clinical trials and assistance with team efforts. Responsibilities: * Develop and improve technology transfer * Organize and lead internal and external meetings in support of projects * Project management oversight of new CROs to meet project timelines * Ongoing support and project management of CRO operations and research collaborations with academic institutes * Assist in the design of product development activities * Develop and have approved CMC plans for CMC and P/T integrated with quality, regulatory, facility and operations functions; Drive the plans ensuring budget, timeline, staffing as well as other program goals are met. (Note that for toxicology, a consultant with such background is necessary for success) * Support the development and protection of intellectual property, trade secrets and unique business practices * Manage existing collaborations, including strategic partnership * Provide scientific leadership in defining the company s product pipeline and in developing corporate strategies and plans * Develop the R&D organization by recruiting critical scientific skills and managing expansion of technical resources and relationships * Support and demonstrate a positive, collaborative approach in working with internal and external colleagues Critical Requirements / Desired Characteristics * Ph.D. in Chemistry or similar scientific discipline with minimum 5+ years of previous experience with a regulated organization, developing and managing radiopharmaceuticals R&D products (strategic and operating plans and budgets as well as building and recruiting a team) * Background in Nuclear Pharmacy, Positron Emission Tomography, Radiation safety, and/or familiarity with cyclotron processes required. * Experience and understanding of Quality (QC/QA) and processes for manufacturing and production with respect to regulatory compliance * Worked in a GMP environment; has product quality or supply chain experience; exposure working to regulatory standards * Experience in PET tracer manufacture * Demonstrated prior success in operating in a small company or entrepreneurial environment * Ability to problem-solve, handle customer service issues, and exercise independent judgment and discretion. We are currently using our Neuraly, Inc. website for all D&D Pharmatech family recruiting efforts. Send resumes to Show moreShow less

Keywords: Precision Molecular Inc, Arlington , Associate Director, RD, Executive , Arlington, Virginia

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