Sr. Director, Pharmacovigilance
2 weeks ago
To promote proper use by conducting necessary internal and external communication such as consultation with the domestic regulatory authority so that safety measures planned based on the risk/benefit evaluation of each product can be appropriately im Regulatory, Director, Business Operations, Evaluation, Operations, Manufacturing, Staffing
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Senior Director, Pharmacovigilance
2 weeks ago
Cambridge, United States Beam Therapeutics Inc. Full timePosition Overview: Unique opportunity to join a growing Pharmacovigilance (PV) team working on cutting edge therapies in the gene editing space. This senior PV role will be responsible for oversight and management of activities pertaining to Beam's drug safety and pharmacovigilance and have line management responsibilities for PV scientist(s). In addition...
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Senior Director, GCP Quality Assurance
7 days ago
Cambridge, United States Scholar Rock Full timeScholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGF?) superfamily of cell proteins and named for the visual resemblance of a scholar rock to protein structures, the...
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Senior Director, GCP Quality Assurance
19 hours ago
Cambridge, United States Scholar Rock Full timeScholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGF?) superfamily of cell proteins and named for the visual resemblance of a scholar rock to protein structures, the...
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Senior Medical Director
2 weeks ago
Cambridge, United States Repare Therapeutics Inc. Full timeReporting to the Vice President of Clinical Development, the Senior Medical Director, is responsible for strategic planning and execution of the assigned clinical program(s) from an end-to-end clinical development perspective, covering phases from IND preparation to approval. You will have experience in the drug development process, particularly early phase...
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Senior Medical Director
4 days ago
Cambridge, United States Repare Therapeutics Full timeDescription Reporting to the Vice President of Clinical Development, the Senior Medical Director, is responsible for strategic planning and execution of the assigned clinical program(s) from an end-to-end clinical development perspective, covering phases from IND preparation to approval. You will have experience in the drug development process, particularly...
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Associate Medical Director, Drug Safety
3 weeks ago
Cambridge, Massachusetts, United States Biogen Full timeJob Description What you’ll do: The Associate Medical Director, Global Safety Physician will be responsible for global pharmacovigilance for investigational and/or marketed products, including review and analysis of safety data, design of clinical trials, identification and investigation of safety signals, management of benefit-risk profile for assigned...
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Medical Director, Clinical Development
2 weeks ago
Cambridge, United States Beam Therapeutics Inc. Full timePosition Overview: The Medical Director in Clinical Development will serve as the Medical Lead for base editing gene therapies in hematology. The Medical Director will work with cross-functional multidisciplinary study teams on clinical development strategy, clinical trial design and execution including medical monitoring of assigned trials, and support...
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Medical Director, Drug Safety
2 days ago
Cambridge, United States Biogen Full timeJob Description You could be just the right applicant for this job Read all associated information and make sure to apply.About This RoleThe Medical Director, Drug Safety is responsible for global pharmacovigilance for marketed and/or investigational products, including review and analysis of safety data from post-marketing sources and from clinical trials,...
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Sr Director/Director, Alliance Management
3 days ago
Cambridge, Massachusetts, United States Fulcrum Therapeutics Full timeCompany Overview Fulcrum Therapeutics is a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases in areas of high unmet medical need. Fulcrum's two lead programs in clinical development are losmapimod, a small molecule for the treatment of facioscapulohumeral muscular dystrophy (FSHD) and...
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Medical Director, Clinical Development
4 days ago
Cambridge, United States Beam Therapeutics Inc. Full timePosition Overview: The Medical Director in Clinical Development will serve as the Medical Lead for base editing gene therapies in hematology. The Medical Director will work with cross-functional multidisciplinary study teams on clinical development strategy, clinical trial design and execution including medical monitoring of assigned trials, and support...
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Medical Director, Drug Safety
4 weeks ago
Cambridge, Massachusetts, United States Biogen Full timeJob Description About This Role The Medical Director, Drug Safety is responsible for global pharmacovigilance for marketed and/or investigational products, including review and analysis of safety data from post-marketing sources and from clinical trials, the identification, and investigation of safety signals, management of benefit-risk profile for...
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Senior Director, Clinical Data Management
3 weeks ago
Cambridge, United States Editas Medicine Full timeJob DescriptionJob DescriptionAt Editas, we’re driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing....
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Senior Medical Director
2 weeks ago
Cambridge, United States Third Rock Ventures Full timeAs a Senior Medical Director at Relay Tx, you will help advance our clinical pipeline from IND to proof of concept to registration. Specifically, you will collaborate with senior medical staff to drive clinical strategy, clinical trial design, and execution. Working cross-functionally with clinical project management, regulatory affairs, clinical operations,...
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Director / Senior Director, Process Chemistry
3 weeks ago
Cambridge, United States Alkeus Pharmaceuticals, Inc. Full timeAbout Alkeus Pharmaceuticals:Alkeus Pharmaceuticals, Inc. is a late-stage biopharmaceutical company developing transformative therapeutics to address serious, progressive eye diseases that lead to blindness. Our lead compound, gildeuretinol (ALK-001), is an oral investigational drug being developed for the treatment of Stargardt disease (STGD) and Geographic...
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Director / Senior Director, Process Chemistry
3 weeks ago
Cambridge, United States Alkeus Pharmaceuticals, Inc. Full timeAbout Alkeus Pharmaceuticals:Alkeus Pharmaceuticals, Inc. is a late-stage biopharmaceutical company developing transformative therapeutics to address serious, progressive eye diseases that lead to blindness. Our lead compound, gildeuretinol (ALK-001), is an oral investigational drug being developed for the treatment of Stargardt disease (STGD) and Geographic...
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Senior Director, Clinical Data Management
3 weeks ago
Cambridge, Massachusetts, United States Editas Medicine Full timeAt Editas, we’re driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing. We believe our people are at...
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Director, Clinical Operations
2 weeks ago
Cambridge, United States Foghorn Therapeutics Inc. Full timeOur Culture: Why work with us? At Foghorn Therapeutics, we believe in "People First, Mission Always." We put "People First" because we know our people are the key to everything we will accomplish. We value the diversity of background, ideas, perspectives and experiences that our team members bring to Foghorn Therapeutics - demonstrated by our community...
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RWE Contract Epidemiologist
2 weeks ago
Cambridge, United States Sarepta Therapeutics Inc. Full timeThe Real World Evidence (RWE) Contract Epidemiologist will provide leadership for scientific prospective and retrospective activities in the RWE team supporting Sarepta. The RWE Contract Epidemiologist will function in a company matrix team environment interacting with several key stakeholder groups including; Clinical Development, Pharmacovigilance,...
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Senior Statistical Programmer
2 weeks ago
Cambridge, United States Prometrika Full timePROMETRIKA is a full-service clinical research organization (CRO) with extensive experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance. We’re driven by our passion for the human aspect of our work and our compassion for the people whose lives have been improved by the innovations we help bring to market....
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Senior Statistical Programmer
2 weeks ago
Cambridge, United States Prometrika LLC Full timeJob DescriptionJob DescriptionPROMETRIKA is a full-service clinical research organization (CRO) with extensive experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance. We’re driven by our passion for the human aspect of our work and our compassion for the people whose lives have been improved by the...