Clinical Safety Lead

2 days ago


Basking Ridge, New Jersey, United States Planet Pharma Full time
Job Summary

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)
Requirements
  • 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


  • Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full time

    Job Title: Clinical Safety Scientist LeadJob Summary:Daiichi Sankyo, Inc. is seeking a highly skilled Clinical Safety Scientist Lead to join our team. As a Clinical Safety Scientist Lead, you will be responsible for proactively performing safety surveillance and risk management in partnership with Product Safety Leads, Clinical Safety Physicians, and...


  • Basking Ridge, New Jersey, United States The Fountain Group Full time

    Job Title: Associate Director - Clinical Safety ScientistJob Schedule: The ideal candidate will be local and able to work in the office 1-2 days a week. Global Travel ~ 20% of Time. Pay rate: $100/Hr.Responsibilities & Job DetailsThis position serves as the Clinical Safety Scientist Lead for a large, late-stage program or multiple early-stage programs,...


  • Basking Ridge, New Jersey, United States Planet Pharma Full time

    Job Title: Associate Director Clinical Safety ScientistThis role serves as the Clinical Safety Scientist Lead for a large, late-stage program or multiple early-stage programs, proactively performing safety surveillance and risk management in partnership with cross-functional teams to support the benefit-risk profile throughout the product lifecycle.The...


  • Basking Ridge, New Jersey, United States Hire Talent Full time

    Job 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...


  • Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full time

    Job 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...


  • Basking Ridge, New Jersey, United States Planet-Pharma Full time

    Job Title: Associate Director Clinical Safety ScientistPlanet-Pharma is seeking an experienced Associate Director Clinical Safety Scientist to lead our safety surveillance and risk management efforts for late-stage programs and early-stage programs.Key Responsibilities:Proactively perform safety surveillance and risk management in partnership with...


  • Basking Ridge, New Jersey, United States Planet Pharma Full time

    Job SummaryWe are seeking a highly skilled Clinical Safety Scientist Lead to join our team at Planet Pharma. As a key member of our safety team, you will be responsible for proactively performing safety surveillance and risk management in partnership with cross-functional teams to support the benefit-risk profile throughout the product lifecycle.Key...


  • 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...


  • Basking Ridge, New Jersey, United States The Fountain Group Full time

    Director, Clinical SafetyThe Fountain Group is seeking a seasoned professional to lead our client's clinical safety efforts. As a key member of the Global Product Team, you will be responsible for developing and implementing a comprehensive product safety strategy.Key Responsibilities:Develop and execute a product safety strategy that aligns with regulatory...


  • Basking Ridge, New Jersey, United States Actalent Full time

    Job Title: Director, Clinical SafetyAbout the RoleThe Director, Clinical Safety will be a key member of our team, responsible for ensuring the safety of our products throughout their lifecycle. This role involves leading safety surveillance and risk management efforts, providing safety leadership, and collaborating with cross-functional teams to...


  • Basking Ridge, New Jersey, United States HireTalent - Diversity Staffing & Recruiting Firm Full time

    Job Title: Pharmacovigilance Partner Management, Clinical Safety & Pharmacovigilance (CSPV) ManagerDuration: 12+ Months (Possibility of extension & conversion)Location: Basking Ridge, NJJob Schedule: 1 day Onsite/week – Possibility to go 100% RemoteJob Description:Key Responsibilities:Manage PV regulatory intelligence and disseminate it to relevant...


  • Basking Ridge, New Jersey, United States Daiichi Sankyo Inc. Full time

    About Daiichi Sankyo Inc.Daiichi Sankyo Inc. is a global pharmaceutical company dedicated to creating innovative therapies to improve healthcare outcomes. With a rich legacy of innovation and a robust pipeline of promising new medicines, we are committed to addressing unmet medical needs and improving the lives of people worldwide.Job SummaryWe are seeking a...


  • Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full time

    Job SummaryWe are seeking a highly experienced Clinical Science Group Lead to join our team at Daiichi Sankyo, Inc. This is a critical role that will lead the development of our late-stage clinical studies and ensure the highest scientific and medical standards are met.Key ResponsibilitiesDevelop and execute the global clinical science strategy for...


  • Basking Ridge, New Jersey, United States Planet Pharma Full time

    Job Title: Medical Safety DirectorPlanet Pharma is seeking a highly skilled Medical Safety Director to lead our Medical Safety team. As a key member of our organization, you will provide leadership, line management, and mentorship for junior Medical Safety Scientists.Key Responsibilities:Lead cross-functional safety management teams and drive safety strategy...


  • Basking Ridge, New Jersey, United States Proclinical Staffing Full time

    Senior Manager, Clinical Study LeadProclinical is seeking a Senior Manager, Clinical Study Lead to oversee and manage clinical study operations.Key Responsibilities:Develop and manage study-specific documentation, ensuring compliance with regulatory requirements.Supervise the setup and maintenance of study systems, including CTMS and TMF.Ensure compliance...


  • Basking Ridge, New Jersey, United States Memorial Sloan Kettering Cancer Center Full time

    Job Title: Clinical Trials Nurse LeadWe are seeking a highly skilled and compassionate Clinical Trials Nurse Lead to join our team at Memorial Sloan Kettering Cancer Center. As a key member of our Ambulatory Care Practice Model, you will be responsible for facilitating the accrual of patients to clinical trials, coordinating patient care activities, and...


  • Basking Ridge, New Jersey, United States Memorial Sloan Full time

    Job Title: Clinical Trials NurseWe are seeking a highly skilled and compassionate Clinical Trials Nurse to join our team at Memorial Sloan Kettering Cancer Center. As a Clinical Trials Nurse, you will play a critical role in providing evidence-based nursing care to oncology patients and families living with cancer.Key Responsibilities:Facilitate accrual of...


  • Basking Ridge, New Jersey, United States BioSpace, Inc. Full time

    Job DetailsWe are seeking an experienced Associate Director to join our Oncology Clinical Development department. The successful candidate will lead the development, evaluation, planning, and execution of clinical studies, ensuring scientific integrity and interpretation of study data for a clinical development program. This role will involve leading a...


  • Basking Ridge, New Jersey, United States Memorial Sloan Full time

    Job Title: Clinical Trials NurseWe are seeking a highly skilled and compassionate Clinical Trials Nurse to join our team at Memorial Sloan Kettering Cancer Center. As a key member of our clinical research team, you will be responsible for providing exceptional patient care and facilitating the accrual of patients to clinical trials.Key Responsibilities:Work...


  • Basking Ridge, New Jersey, United States Memorial Sloan Full time

    Job Title: Clinical Trials NurseWe are seeking a highly skilled and compassionate Clinical Trials Nurse to join our team at Memorial Sloan Kettering Cancer Center. As a Clinical Trials Nurse, you will play a critical role in providing evidence-based nursing care to patients and families living with cancer.Responsibilities:Facilitate accrual of appropriate...