Senior Medical Director
3 weeks ago
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 early phase clinical trials, protocol writing and study conduct, data review and reconciliation, and what it takes to lead teams successfully. This position offers the opportunity for growth and development while working in a vibrant environment. Responsibilities: Establish clinical development plans and deliver on program milestones, in partnership with clinical leadership. Work effectively with in a matrix environment with other functions. As a senior member of the clinical study physicians team, provide leadership, mentorship, and guidance to other team members. Serve as the Medical Monitor on one or more studies. Author and review clinical documents required for the conduct of clinical studies, such as clinical protocols, amendments, informed consent documents, investigator brochures. Author and review clinical sections of regulatory documents, including INDs, annual safety reports and briefing packages. Lead clinical engagement with IRBs and Ethics committees. Work closely with internal teams and CROs in execution of trials, and provide ongoing guidance to CRO for protocol-specific clinical issues, site problems, and recruitment strategies. Serve as medical point of contact with sites: answer site questions about patient eligibility, enrollment and provide clinical input into patient safety assessment and management. Participate in ongoing clinical data cleaning and review and contribute to clinical study report drafting and/or review. Lead ongoing data review, analysis, and interpretation to understand safety and efficacy profile. May act as a core member of the Safety Management Team (SMT), supporting overall program safety interpretation and reporting in collaboration with Pharmacovigilance team members. Present clinical program at Site Initiation Visits, Investigator's Meetings, and scientific conferences. Prepare presentation materials for internal and external meetings, such as clinical team meetings, Scientific and Clinical Advisory Boards and Board of Director meetings. Identify and build collaborative relationships with key opinion leaders and institutions to assure incorporation of latest methods and guidelines into clinical development plans. Lead all aspects of planning and management of investigator meetings, advisory boards and other scientific committees. Co-author and present abstracts, posters, and oral presentations for scientific and clinical meetings. Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research. Work effectively with in a matrix environment with other functions. Provide clinical input into discovery initiatives and for business development activities. Manage a team of Medical Directors. Some Travel required. M.D required, with board certification in oncology preferred. Minimum of 4 years in oncology drug development, including early phase experience, with majority in pharmaceutical environment; experience in solid tumor oncology drug development is required. Experience leading a team through execution of clinical development plans. Strong people leadership abilities. Ability to thrive in a dynamic, innovative and cross- functional environment. Operates as a strategic leader and hands-on problem solver. Excellent interpersonal skills, ability to develop important relationships with key stakeholders, conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans and recommendations. Excellent oral and written skills. Strong interpersonal skills with a focus on results and outcomes. Strong attention to detail, creativity, independent thinking and results orientation. Ability to understand stakeholder concerns and frame issues/proposals to influence decisions.
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Senior Medical Director
1 month 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
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
1 month 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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Senior Medical Director
1 month 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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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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Medical Director
3 weeks ago
Cambridge, United States FogPharma Full timeWhy join us? FogPharma is a biopharmaceutical company pioneering the discovery and development of Helicon™ therapeutics, which are peptides capable of efficient cell entry and modulation of both protein-protein and protein-DNA interactions. Through Helicon therapeutics, FogPharma is poised to revolutionize the medical possibilities for patients by...
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Medical Director
5 days ago
Cambridge, United States FogPharma Full timeWhy join us? FogPharma is a biopharmaceutical company pioneering the discovery and development of Helicon™ therapeutics, which are peptides capable of efficient cell entry and modulation of both protein-protein and protein-DNA interactions. Through Helicon therapeutics, FogPharma is poised to revolutionize the medical possibilities for patients by...
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Senior Medical Director, Global Rare
7 hours ago
Cambridge, United States Alnylam Full timeOverview The Medical Senior Director Global Rare, reporting into the VP, Medical Affairs Head Global Rare, will be responsible for building and for developing strategies and tactical execution plans in the Rare TAs at Alnylam. He/she will be the key driver of activities to engage health care professionals, and medical organizations. The Senior Medical...
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Senior Director for Finance
2 weeks ago
Cambridge, United States Massachusetts Institute of Technology Full timeSENIOR DIRECTOR FOR FINANCE, Office of the Vice President for Research (OVPR), to serve as OVPR's chief financial officer. Will provide strategic counsel to the VPR and support the research enterprise at MIT by providing expertise, leadership, and ov Director, Finance, Senior, Financial, Research, Operations, Technology, Education
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Cambridge, United States Harvard University Full timeReporting to the Vice President for Finance and Chief Financial Officer, the Senior Director of Finance and Administration is responsible for overseeing the financial, operational and administrative elements of Financial Administration (FAD) at Harva Director, Finance, Senior, Project Management, Education
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Cambridge, Massachusetts, United States Intellia Therapeutics Full timeWhy Join Intellia?Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases.Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determination to...
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Cambridge, Massachusetts, United States Intellia Therapeutics Full timeWhy Join Intellia?Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases.Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determination to...
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Senior Medical Manager US
3 weeks ago
Cambridge, United States Biogen Full timeAbout this role. The Senior Medical Manager is a part of US Medical Rare Disease, a strategic partner within Biogen that helps inform medical practice across our therapeutic areas and pipeline to improve meaningful patient outcomes. As a key member o Medical, Manager, Medical Director, Senior, Clinical, Communications, Technology, Healthcare
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Senior Director, Field Medical Affairs
3 weeks ago
Cambridge, United States Apnimed Full timeApnimed is a well-funded, clinical-stage pharmaceutical company working to transform the treatment of sleep apnea based on a simple idea – patients with obstructive sleep apnea could benefit from treatment with a safe and effective oral medication dosed once daily at bedtime. Our lead development program targets the neurologic control of upper airway...
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Senior Director, Field Medical Affairs
3 weeks ago
Cambridge, United States Apnimed Full timeApnimed is a well-funded, clinical-stage pharmaceutical company working to transform the treatment of sleep apnea based on a simple idea – patients with obstructive sleep apnea could benefit from treatment with a safe and effective oral medication dosed once daily at bedtime. Our lead development program targets the neurologic control of upper airway...
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Senior Director, Field Medical Affairs
2 weeks ago
Cambridge, United States Apnimed Full timeApnimed is a well-funded, clinical-stage pharmaceutical company working to transform the treatment of sleep apnea based on a simple idea – patients with obstructive sleep apnea could benefit from treatment with a safe and effective oral medication dosed once daily at bedtime. Our lead development program targets the neurologic control of upper airway...
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Cambridge, United States Repertoire Immune Medicines Full timeJob DescriptionJob DescriptionDirector/Senior Director, Program and Alliance Management Repertoire Immune Medicines is a biotechnology company working to unlock and direct the remarkable power of the human immune system to treat cancer, autoimmune disease, and infectious disease. The company was founded by Flagship Pioneering on the belief that understanding...
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Cambridge, United States Repertoire Immune Medicines Full timeJob DescriptionJob DescriptionDirector/Senior Director, Program and Alliance Management Repertoire Immune Medicines is a biotechnology company working to unlock and direct the remarkable power of the human immune system to treat cancer, autoimmune disease, and infectious disease. The company was founded by Flagship Pioneering on the belief that understanding...
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Senior Director
3 weeks ago
Cambridge, Massachusetts, United States Bristol Myers Squibb Full timeWorking with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the...
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Cambridge, United States Harvard University Full timeWithin the Office of the Vice Provost for Research, the Senior Director of Compliance for Strategic Research Initiatives (SDCSRI) is responsible for the oversight of institution-wide efforts toward securing large-scale funding opportunities for strat Director, Research, Compliance, Compliance Officer, Strategic, Senior, Technology, Education
