Senior Medical Director, Clinical Development, CV/Metabolism
3 weeks ago
Role SummaryThe Senior Medical Director, Clinical Development, will play a key role in clinical development programs within the Internal Medicine portfolio focused on obesity and related comorbidities. This role serves as Scientific and Medical Lead for Clinical team(s) working closely with Operational Leads to guide and execute clinical development strategies and subsequent regulatory submissions. This role requires a high-performing and highly passionate individual who serves as a clinical role model for the team and demonstrates outstanding clinical scientific knowledge applicable to clinical research. The Senior Medical Director reports to an Executive Medical Director, Internal Medicine.ResponsibilitiesActs as medical expert and leader in interactions with external stakeholdersDevelops unique and innovative clinical strategies to significantly shorten the development cycle in the face of an evolving regulatory landscape. Designs and develops more efficient and innovative, yet robust Phase 2/3 programs.Works closely with discovery teams to provide input on the next generation of targets in the field and leads the development of plans for Phase 1 clinical testing for initial characterization of the molecules PK/PD and safety.Ensures safety of the drug, including the safety aspects of patients in clinical studies and signal detection from post-marketing surveillance, with the support from Global Patient Safety.Plans and executes publication and clinical communication strategy in coordination with Publications team. Provides input to key external presentations.Ensures quality of all clinical documents (e.g., Investigators’ Brochure, protocol, study report, clinical components of regulatory submissions, safety related documents). Develops written responses to regulatory agency questions and regulatory submission documents.QualificationsRequired: A minimum of an advanced degree in medicine (i.e., M.D. or D.O. or equivalent).Preferred: Clinical training in Endocrinology, Cardiology, Nephrology, Internal Medicine (board certified or eligible or equivalent).Required: A minimum of 3-4 years of industry experience in early or late developmentRequired: Past experience in leading clinical trials including: protocol design, managing study start-up, directing and guiding study team execution, data cleaning, medical monitoring/review, database locks.Preferred: Experience with regulatory filings and interactions with health authoritiesSkillsClinical development leadershipRegulatory strategy and submissionsMedical communication and publication planningCross-functional collaboration with discovery, safety, and publications teamsEducationAdvanced medical degree (MD, DO, or equivalent)Additional RequirementsOn-site presence required 4 days a week in Tarrytown, NY; Cambridge, MA may be considered. #J-18808-Ljbffr
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Village of Tarrytown, United States Regeneron Full timeExecutive Medical Director, Clinical Development, (Thrombosis)Join to apply for the Executive Medical Director, Clinical Development, (Thrombosis) role at RegeneronExecutive Medical Director, Clinical Development, (Thrombosis)3 weeks ago Be among the first 25 applicantsJoin to apply for the Executive Medical Director, Clinical Development, (Thrombosis) role...
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Medical Director, Clinical Development, Oncology
2 weeks ago
Village of Tarrytown, United States Regeneron Full timeMedical Director, Clinical Development, Oncology (Gynecologic Cancers) Join to apply for the Medical Director, Clinical Development, Oncology (Gynecologic Cancers) role at Regeneron. Overview The Medical Director, Clinical Sciences, Oncology is a qualified physician-scientist with exceptional clinical trials experience, preferably in solid tumor Oncology...
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Medical Director, Clinical Sciences, Hematology
3 weeks ago
Village of Tarrytown, United States Scorpion Therapeutics Full timeRole Summary Medical Director, Clinical Sciences focused on hematology, serving as clinical leader of a section within a clinical program under the guidance of the Program Lead Medical Director or Sr. Medical Director. Responsibilities Provides clinical leadership and is responsible for all clinical deliverables within the assigned section of a clinical...
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Medical Director, Clinical Sciences, Hematology
3 weeks ago
Village of Tarrytown, United States Regeneron Full timeMedical Director, Clinical Sciences, Hematology Apply for the Medical Director, Clinical Sciences, Hematology role at Regeneron. Overview The Medical Director, Clinical Sciences functions as the clinical leader of a section of a clinical program under the leadership of Program Lead Medical Director or Sr. Medical Director. Responsibilities Provides clinical...
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Tarrytown, New York, United States Regeneron Full timeRegeneron seeks a leader in skeletal muscle physiology and biology to head its research and therapeutic development team. This group uses various cutting-edge molecular cell biology, genetic, and transcriptomic profiling techniques, as well as genetic animal models to understand muscle physiology and pathophysiology at the cellular and molecular level. This...
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Medical Director, Hematology
2 weeks ago
Village of Tarrytown, United States Regeneron Full timeA leading biotechnology company in Tarrytown seeks a Medical Director for Clinical Sciences in Hematology. The role involves clinical leadership in drug development and collaboration with various stakeholders to shape innovative therapies. Candidates should possess an MD with Hematology/Oncology fellowship and have significant experience in clinical research...
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Director, Biostatistics
3 weeks ago
Village of Tarrytown, United States Regeneron Full timeJoin to apply for the Director, Biostatistics - Obesity role at Regeneron. This position is for a qualified statistician/biostatistician to support Clinical Biostatistics within Global Development. It requires a strong background in biostatistics, exceptional leadership capabilities, and the ability to contribute meaningfully to drug development and...
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Senior Director, Global Patient Safety
1 week ago
Tarrytown, United States Regeneron Full timeSenior Director (Obesity)Regeneron's Patient Safety Organization is looking for a Senior Director (Obesity) to join our organization!In this role, a typical day might include:Reporting to the Global Patient Safety (GPS) Therapeutic Area (TA) Head, the Senior Director GPS Lead, serves as the first point of contact (POC) for all safety related issues for the...
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Senior Medical Director, Medical Affairs
2 weeks ago
Village of Sleepy Hollow, United States Regeneron Full timeOverviewSenior Medical Director, Medical Affairs Team Lead, is a pivotal and strategic leadership role within Regeneron’s Rare Diseases & Cardio-Metabolic franchise. Reporting to the Vice President of Global Medical Affairs, General Medicine, this individual drives the creation and execution of medical strategies for multiple rare disease assets, ensuring...
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Senior Medical Director
4 weeks ago
Tarrytown, United States Regeneron Full timeSenior Medical Director, Medical Affairs MASH AssetsThe Senior Medical Director, Medical Affairs MASH Assets, will play a pivotal and highly visible strategic leadership role within the organization, reporting directly to the VP, Medical Affairs, General Medicine. This role is responsible for driving the medical strategy and execution for MASH assets, with a...
