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This position will be responsible for developing and executing robust health economics, outcomes research, epidemiology and real-world evidence plans for a leading pipeline product (oncology) in alignment with brand strategies, medical affairs strategies, clinical development plans, support product value propositions, and market access.
$206,250 - $343,750 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Actively contribute to the development of regulatory strategies for investigational products in Investigational New Drug (IND)/ Clinical Trial Applications (CTA), Biologics Licensing Application (BLAs)/ Marketing Authorization Application (MAA), through evaluating scientific merits of Chemistry, Manufacturing and Control (CMC) and nonclinical study data package.
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Responsible for generation of key study documents and medical oversight of clinical study conduct; Collaborates closely with internal stakeholders, (i.e. Regulatory Affairs, Product Development, Research and Development (R&D), Quality Assurance (QA), Pharmacovigilance, Medical Affairs, etc.
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The Clinical Research Director (CRD) is the primary clinical lead for programs and responsible for leading successful clinical trials for novel therapeutics for Ophthalmologic Diseases.
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The Medical Director, Bladder - Global Medical Affairs Oncology, will be a member of the Global Medical Affairs team, leading the conduct of a global clinical study using the portfolio of compounds at Janssen with the aim of building curative regimens for patients with bladder cancer.
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Excellent knowledge of current Good Clinical Practices (GCP) and Good Laboratory Practices (GLP), research ethics and applicable statutes and guidances in the pharmaceutical industry. Collaborates with assigned Clinical Research Organization (CRO) and/or Medical Writer to contribute to drafting of clinical study reports and other reporting data documents; Participates in ongoing data reviews (i.e., blinded reviews, later data outputs, etc.
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In coordination with the CMO and other heads of Medical Affairs, develop and implement strategy and tactics for an integrated US Medical Plan for Endocrinology (Medical Education, Medical Communications and Publications, Health Outcomes, Safety and Clinical Research (Phase IIIB/Phase IV and investigator-sponsored studies (ISS.
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The Senior Director of Clinical Development Medical Affairs (CDMA) oversees the strategic planning and execution of our nitric oxide program, ensuring alignment with brand objectives, incorporation of insights, and the development of an R&D plan addressing unmet patient needs and competitive differentiation.
$245,000 - $255,000 a yearFull-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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These partners including US commercial colleagues, Portfolio Marketing, Marketing Excellence & Operations, B&OS, Flu Operations, Medical, Public Affairs, Market Access and Finance, as well as Global partners such as Franchise and Brand Excellence.
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The Associate Director will work closely with HEOR team members and others across the company including market access, marketing, medical affairs, and clinical development to support Insmed’s business needs.
$140,000 - $200,000 a yearFull-timeExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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This position reports to VP, CDMA with a dotted line reporting relationship to the CSO. The Senior Director CDMA will interact with internal colleagues in Research and Development (Clinical Development & Medical Affairs, Strategic Operations, Evidence Generation & Data Sciences, Regulatory Affairs, Pharmacovigilance) Strategy/Portfolio Management, Global Device Engineering, Commercial and Operations functions.
$215,000 - $275,000 a yearFull-timeExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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Work closely with individual clinical teams as well as functional area partners (e.g., Translational research, Precision Medicine and diagnostics, Regulatory Affairs, Market Access, Clinical Development) to identify and implement end-to-end Data Science solutions aimed at facilitating decision making.
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