Clinical Safety Lead
4 weeks ago
We are seeking a highly skilled Clinical Safety Scientist to lead our safety surveillance and risk management efforts for a large, late-stage program or multiple early-stage programs. The ideal candidate will have a strong background in clinical development and safety risk management, with experience in proactively identifying and mitigating safety risks.
Key Responsibilities- Collaborate with cross-functional teams to develop and implement safety strategies and risk management plans
- Lead the coordination of Safety Management Team (SMT) meetings and maintain records of discussions and decisions
- Evaluate safety data to identify potential safety signals and perform safety analysis and evaluation
- Develop and communicate safety action recommendations and risk minimization plans to stakeholders
- Oversee the tracking of safety signals in global electronic signal tracking tools
- Collaborate with Product Safety Leads and Clinical Safety Physicians to plan and prioritize activities for Biologics License Applications (BLAs) and Marketing Authorization Applications (MAAs)
- Advanced degree in a relevant field (e.g. pharmacology, toxicology, epidemiology) and 3-5 years of experience, or a bachelor's degree and 6-9 years of experience
- Proven experience in clinical development and safety risk management, with a strong understanding of safety regulations and guidelines
- Excellent communication and interpersonal skills, with the ability to work effectively in a matrixed environment
- Ability to develop and build healthy working relationships to enable higher performance
- Effective oral and written communication skills, with the ability to present complex information to stakeholders
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Clinical Safety Scientist Lead
4 weeks ago
Basking Ridge, New Jersey, United States Hire Talent Full timeJob Title:Associate Director Clinical Safety ScientistJob Summary:We are seeking an experienced Associate Director Clinical Safety Scientist to lead our clinical safety and risk management efforts. The successful candidate will be responsible for proactively performing safety surveillance and risk management in partnership with cross-functional teams to...
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Clinical Safety Scientist Lead
4 weeks ago
Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full timeJob Title: Associate Director, Clinical Safety ScientistAbout Daiichi Sankyo, Inc.Daiichi Sankyo, Inc. is a leading pharmaceutical company dedicated to creating innovative therapies to improve standards of care and address unmet medical needs globally. With a rich legacy of innovation and a robust pipeline of promising new medicines, we are committed to...
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Clinical Safety Scientist Lead
3 weeks ago
Basking Ridge, New Jersey, United States BioSpace, Inc. Full timeJob DetailsBioSpace, Inc. is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology.SummaryThis position serves as the Clinical Safety Scientist Lead for a large, late-stage program or multiple...
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Clinical Safety Scientist Lead
3 weeks ago
Basking Ridge, New Jersey, United States BioSpace, Inc. Full timeJob Summary:We are seeking a highly skilled Clinical Safety Scientist Lead to join our team at BioSpace, Inc. in the Oncology department. As a key member of our team, you will be responsible for proactively performing safety surveillance and risk management in partnership with Product Safety Leads, Clinical Safety Physicians, and cross-functional teams to...
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Basking Ridge, New Jersey, United States The Fountain Group Full time{"title": "Clinical Safety Scientist Associate Director", "subtitle": "Join The Fountain Group", "content": "Clinical Safety Scientist Associate DirectorWe are seeking a highly skilled Clinical Safety Scientist Associate Director to join our team at The Fountain Group. As a key member of our safety team, you will be responsible for proactively performing...
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Clinical Safety Scientist Lead
4 weeks ago
Basking Ridge, New Jersey, United States Planet Pharma Full timepbJobSummary/b/ppWeareseekingahighlyskilledClinicalSafetyScientistLeadtojoinourteamatPlanetPharma.Asakeymemberofoursafetyteam,youwillberesponsibleforproactivelyperformingsafetysurveillanceandriskmanagementinpartnershipwithcross-functionalteamstosupportthebenefit-riskprofilethroughouttheproductlifecycle./ppbKeyResponsibilities/b/pulliCollaboratewithProductSaf...
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Safety Leadership Director
3 weeks ago
Basking Ridge, New Jersey, United States Actalent Full timeJob Title: Director, Clinical SafetyAbout the Role:The Director, Clinical Safety, will be a product safety lead or part of a product safety team, responsible for overall product safety strategy or specific areas of safety surveillance and risk management.This role provides safety leadership including but not limited to clinical studies, post-marketing...
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Senior Product Safety Strategist
3 weeks ago
Basking Ridge, New Jersey, United States The Fountain Group Full timeThe Fountain Group is seeking a Senior Product Safety Strategist to lead product safety strategy and risk management for a prominent Pharmaceutical client.This role involves developing and implementing safety strategies, collaborating with cross-functional teams, and ensuring proactive safety monitoring and risk management.Key responsibilities...
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Senior Product Safety Manager
3 weeks ago
Basking Ridge, New Jersey, United States The Fountain Group Full timeThe Fountain Group is seeking a Senior Product Safety Manager to lead the overall product safety strategy for a prominent Pharmaceutical client.This role will be responsible for proactive safety monitoring and risk management through the Safety Management Team framework.The ideal candidate will have strong leadership and communication skills to ensure...
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Product Safety Strategist
3 weeks ago
Basking Ridge, New Jersey, United States Actalent Full timeJob Title: Product Safety StrategistAbout the Role:The Product Safety Strategist will be responsible for developing and implementing a comprehensive product safety strategy, ensuring the safety of our products throughout their lifecycle. This role will involve collaborating with cross-functional teams to identify and mitigate potential safety risks, as well...
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Senior Manager of Global Patient Safety
4 weeks ago
Basking Ridge, New Jersey, United States Regeneron Pharmaceuticals Full timeJob SummaryWe are seeking a Senior Manager of Global Patient Safety to play a key scientific role in safety strategies for molecules in clinical development and post-marketing phases in the Ophthalmology Therapeutic Area.Key ResponsibilitiesPerform signal evaluation for identified signals and author the safety evaluation reports and Health Hazard ReportsRun...
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Deck and Safety Manager
4 weeks ago
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Associate Director, Clinical Science
4 weeks ago
Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full timeStudy Strategy:Develops and implements clinical study strategies to ensure successful trial execution. Collaborates with Biostats, Data Management, and Data Operations to design and implement data management plans, edit checks, and data quality listings. Reviews patient population and protocol compliance to ensure consistency with study strategy.Study...
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Clinical Science Director
4 weeks ago
Basking Ridge, New Jersey, United States BioSpace, Inc. Full timeJob OverviewAs a Clinical Science Director at Daiichi Sankyo, you will oversee one or more trials of medium to high complexity in design and geographic scope. This role requires strategic direction, clinical expertise, and leadership skills to drive the success of our clinical development programs. Key ResponsibilitiesDevelop and implement clinical study...
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Clinical Trial Manager
4 weeks ago
Basking Ridge, New Jersey, United States ShiftCode Analytics Full timeJob SummaryThe Senior Clinical Study Lead - Clinical Experimental Sciences Operations is accountable for the execution of assigned clinical studies/research collaborations from study design, through execution, to study close out. This role requires strong leadership and operational skills to oversee the contract and budget execution, study timelines, and...
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Crew Lead Position
4 weeks ago
Basking Ridge, New Jersey, United States Savatree Full timeAbout the RoleSavATree is seeking a highly skilled and experienced Crew Lead to join our General Tree Care Team. As a Crew Lead, you will be responsible for providing leadership and direction to a team of arborists, ensuring the highest level of quality and safety in tree care services.Key ResponsibilitiesLead a team of arborists in providing high-quality...
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Associate Director, Clinical Science
4 weeks ago
Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full timeJob Title: Associate Director, Clinical ScienceAbout the Role:Daiichi Sankyo, Inc. is seeking an experienced Associate Director, Clinical Science to join our team. In this role, you will oversee clinical trials, prepare regulatory documents, and collaborate with AROs/CROs. You will also provide medical and scientific direction to Clinical Operations and...
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Clinical Director, Oncology Research
3 weeks ago
Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full timeLead Clinical Development in OncologyDaiichi Sankyo, Inc. is seeking a highly skilled Clinical Director to lead clinical development in oncology. As a key member of our team, you will oversee non-pivotal trials, prepare clinical sections of regulatory documents, and collaborate with AROs/CROs.Key Responsibilities:Develop study strategies and provide input on...
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Senior Statistical Programmer Lead
4 weeks ago
Basking Ridge, New Jersey, United States Regeneron Pharmaceuticals Full timeJob SummaryThe Senior Statistical Programmer Lead will oversee and support all programming activities in accordance with project strategies, ensuring timely and high-quality deliverables. This role requires the ability to work independently and collaboratively with internal and external stakeholders to drive programming efforts.Key ResponsibilitiesLead...
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Senior Manager, Pharmacy Support Services Lead
4 weeks ago
Basking Ridge, New Jersey, United States BioSpace, Inc. Full timeJob SummaryThe Senior Manager, Pharmacy Support Services Lead is responsible for driving activities related to Investigational Product used in the conduct of clinical research projects to ensure consistent deliverable of program objectives across our portfolio.This role partners with Formulation Development Group (FDG), as a SME in investigational product...