Current jobs related to Medical Director, Drug Safety - Cambridge - Stratacuity: Proven Scientific Placement
-
Cambridge, Massachusetts, United States Bicycle Therapeutics Full timeJob Title: Director, Drug Safety and PharmacovigilanceJob Summary:Bicycle Therapeutics is seeking a highly experienced Director, Drug Safety and Pharmacovigilance to lead the clinical safety activities for assigned compounds within the organization. The successful candidate will be responsible for the implementation, execution, and management of...
-
Cambridge, 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...
-
Director, Drug Safety
1 day ago
Cambridge, United States Bicycle Therapeutics Full timeBicycle Therapeutics is a clinical-stage pharmaceutical company developing a novel class of medicines, referred to as Bicycle® molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural geometry. This...
-
Director, Drug Safety
2 hours ago
Cambridge, United States Bicycle Therapeutics Full timeBicycle Therapeutics is a clinical-stage pharmaceutical company developing a novel class of medicines, referred to as Bicycle® molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural geometry. This...
-
Director, Preclinical Drug Safety
4 weeks ago
Cambridge, United States Blueprint Medicines Full timeHow will your role help us transform hope into reality? Reporting to the Vice President of Preclinical Drug Safety, you will be responsible for developing and implementing toxicology strategies for multi-disciplinary program teams. You will play a critical role helping derisk and advance the research pipeline by leveraging your toxicology expertise,...
-
Director, Preclinical Drug Safety
3 weeks ago
Cambridge, United States Blueprint Medicines Full timeHow will your role help us transform hope into reality?Scroll down the page to see all associated job requirements, and any responsibilities successful candidates can expect.Reporting to the Vice President of Preclinical Drug Safety, you will be responsible for developing and implementing toxicology strategies for multi-disciplinary program teams. You will...
-
Cambridge, United States Leap Therapeutics Full timeCompany Summary: Leap Therapeutics (Nasdaq: LPTX) is focused on developing targeted and immuno-oncology therapeutics. Leap’s most advanced clinical candidate, DKN-01, is a humanized monoclonal antibody targeting the Dickkopf-1 (DKK1) protein. DKN-01 is being developed in patients with esophagogastric, gynecologic, and colorectal cancers. FL-301, is a...
-
Cambridge, Massachusetts, United States Scholar Rock Full timeAbout Scholar RockScholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. Our focus is on advancing innovative treatments where protein growth factors play a fundamental role.Job SummaryWe are seeking a highly motivated and enthusiastic Medical...
-
Director of Drug Substance Manufacturing
3 weeks ago
cambridge, United States QurAlis Full timeABOUT THE COMPANY At QurAlis, we are neuro pioneers on a quest to cure. We work with a relentless pursuit of knowledge, a precise attention to craft, and an optimistic mindset to discover and develop effective precision medicines that will alter the trajectory of amyotrophic lateral sclerosis (ALS), frontotemporal dementia (FTD), and other neurodegenerative...
-
Director of Drug Substance Manufacturing
3 weeks ago
cambridge, United States QurAlis Full timeABOUT THE COMPANY At QurAlis, we are neuro pioneers on a quest to cure. We work with a relentless pursuit of knowledge, a precise attention to craft, and an optimistic mindset to discover and develop effective precision medicines that will alter the trajectory of amyotrophic lateral sclerosis (ALS), frontotemporal dementia (FTD), and other neurodegenerative...
-
Director of Drug Substance Manufacturing
4 months ago
Cambridge, United States QurAlis Full timeABOUT THE COMPANY At QurAlis, we are neuro pioneers on a quest to cure. We work with a relentless pursuit of knowledge, a precise attention to craft, and an optimistic mindset to discover and develop effective precision medicines that will alter the trajectory of amyotrophic lateral sclerosis (ALS), frontotemporal dementia (FTD), and other neurodegenerative...
-
Director of Drug Substance Manufacturing
4 months ago
Cambridge, United States QurAlis Full timeABOUT THE COMPANY At QurAlis, we are neuro pioneers on a quest to cure. We work with a relentless pursuit of knowledge, a precise attention to craft, and an optimistic mindset to discover and develop effective precision medicines that will alter the trajectory of amyotrophic lateral sclerosis (ALS), frontotemporal dementia (FTD), and other neurodegenerative...
-
Cambridge, Massachusetts, United States Leap Therapeutics Full timeAbout the RoleLeap Therapeutics is seeking a highly experienced Senior Director to lead our Pharmacovigilance and Safety Operations team. As a key member of our organization, you will be responsible for overseeing the safe and effective development of our therapeutics.Key ResponsibilitiesStrategic Planning and Leadership: Develop and implement strategic...
-
Cambridge, Massachusetts, United States Leap Therapeutics Full timeJob SummaryWe are seeking a highly experienced and skilled Senior Director to lead our Pharmacovigilance and Safety Operations team at Leap Therapeutics. As a key member of our organization, you will be responsible for overseeing the safe and effective development of our therapeutics, ensuring compliance with regulatory guidelines, and driving strategic...
-
Cambridge, Massachusetts, United States Leap Therapeutics Full timeJob SummaryWe are seeking a highly experienced and skilled Senior Director to lead our Pharmacovigilance and Safety Operations team at Leap Therapeutics. As a key member of our organization, you will be responsible for overseeing the operational aspects of pharmacovigilance, ensuring compliance with regulatory guidelines, and driving strategic planning to...
-
Director of Drug Substance Development
4 days ago
Cambridge, Massachusetts, United States Stratacuity: Proven Scientific Placement Full timeJob Title: Director of Drug Substance DevelopmentLocation: Cambridge, MA (Onsite)Job Overview: We are seeking a highly experienced Director of Drug Substance Development to lead our CMC Drug Substance efforts. As the process chemistry SME, you will oversee the strategy and operations of our drug substance development programs in clinical development leading...
-
Vice President, Drug Safety
4 months ago
Cambridge, United States Bicycle Therapeutics Full timeJob DescriptionJob DescriptionCompany DescriptionBicycle Therapeutics is a clinical-stage biopharmaceutical company developing a novel class of medicines, referred to as Bicycle® molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two...
-
Cambridge, Massachusetts, United States Leap Therapeutics Full timeJob SummaryLeap Therapeutics is seeking a highly experienced Senior Director to lead our Pharmacovigilance Operations team. As a key member of our safety organization, you will be responsible for overseeing the operational aspects of pharmacovigilance, ensuring compliance with regulatory guidelines, and driving strategic planning and implementation of safety...
-
Cambridge, Massachusetts, United States Bicycle Therapeutics Full timeJob Title: Associate Director of Drug Metabolism and PharmacokineticsBicycle Therapeutics is a clinical-stage pharmaceutical company developing innovative medicines for underserved diseases. We are seeking an experienced Associate Director of Drug Metabolism and Pharmacokinetics (DMPK) to join our team.Key Responsibilities:Design and execute non-clinical...
-
Director of Drug Substance Development
2 weeks ago
Cambridge, Massachusetts, United States Stratacuity: Proven Scientific Placement Full timeJob Overview:We are seeking a highly experienced professional to lead our CMC Drug Substance efforts as the process chemistry SME for programs in clinical development leading to NDA. As the Director of Drug Substance Development, you will oversee the strategy and operations of our CMC efforts, ensuring efficiency, quality, and deliverables.Key...
Medical Director, Drug Safety
4 months ago
Location: Cambridge MA (Onsite)
Science/ Focus: CRISPR/Cas9
Therapeutic Area: Rare Disease
Job Overview: This position is well-suited for a Medical Director with substantial expertise in drug development and safety, providing a unique opportunity to strategize the implementation of safety surveillance for clinical trials, oversee the management of safety signals, take charge of cross-functional teams, and contribute to the development of regulatory safety deliverables.
Primary Job Responsibilities:
Collaborate with the clinical development team to develop and implement a comprehensive safety surveillance strategy for clinical trials across different platforms. Manage and prioritize safety signals by leading a cross-functional safety management team, ensuring effective risk mitigation and response. Lead a cross-functional project focusing on the development of guidance for the long-term safety assessment of gene-editing products, ensuring compliance with regulatory requirements and best practices.Primary Job Requirements:
MD with 10+ years of experience in drug development and drug safety/pharmacovigilance, with specific expertise in clinical oncology, immunology, or genetics Strong knowledge and hands-on experience with good pharmacovigilance practices and international regulatory requirements such as EMA/FDA/ICH guidelines. Proven track record of leading and authoring safety guidance documents, position papers, and safety sections of IND or BLA submission dossiers. Prior experience in gene therapy products or biologics, demonstrating the ability to navigate the unique challenges of pharmacovigilance in these areas.About Stratacuity:
Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
PROVEN SCIENTIFIC PLACEMENT™
Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.
