Current jobs related to Manager Clinical Safety Scientist - Basking Ridge, New Jersey - Daiichi Sankyo

  • Lead Clinical Safety Scientist

    1 week ago

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

    The Fountain Group is currently in search of a Lead Clinical Safety Scientist for a significant client. This role is designed for a professional with expertise in clinical safety and risk management. Below are the details for this opportunity:Work Arrangement: The manager prefers candidates who can be onsite 1-2 days per week.Travel Requirements: Global...

  • Safety Scientist Director

    9 hours ago

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

    The Fountain Group is seeking a seasoned Clinical Safety Scientist Lead to join our team. This is a temporary assignment that is slated for 1 year with possibility for extension or conversion based on performance and budget.Job Summary: The Clinical Safety Scientist Lead will serve as the lead for a large, late-stage program or multiple early-stage programs,...

  • Clinical Safety Expert

    10 hours ago

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

    The Fountain Group is seeking a seasoned Clinical Safety Scientist Lead to join our team. This is a temporary assignment that is slated for 1 year with possibility for extension or conversion based on performance and budget.Key Responsibilities:Proactively perform safety surveillance and risk management in partnership with Product Safety Lead(s), Clinical...

  • Associate Director, Clinical Safety MD

    3 months ago

    Basking Ridge, New Jersey, United States Daiichi Sankyo Full time

    Join a Legacy of Innovation 110 Years and CountingDaiichi Sankyo Group 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. With more than 120 years of scientific expertise and a presence...

  • Data Scientist

    2 months ago

    Basking Ridge, New Jersey, United States Daiichi Sankyo Full time

    Join a Legacy of Innovation 110 Years and CountingDaiichi Sankyo Group 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. With more than 100 years of scientific expertise and a presence...

  • Associate Director, Clinical Scientist

    3 months ago

    Basking Ridge, New Jersey, United States Daiichi Sankyo Full time

    Join a Legacy of Innovation 110 Years and CountingDaiichi Sankyo Group 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. With more than 100 years of scientific expertise and a presence...

  • Senior Director Translational Patient Safety

    1 month ago

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

    With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people.To succeed as global pharma innovator in oncology, a therapeutic area known for accelerated development and...

  • Manager, Clinical Data Management

    3 weeks ago

    Basking Ridge, New Jersey, United States Daiichi Sankyo Full time

    Join a Legacy of Innovation 110 Years and CountingDaiichi Sankyo Group 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. With more than 100 years of scientific expertise and a presence...

  • Clinical Data Management Lead

    5 days ago

    Basking Ridge, New Jersey, United States Daiichi Sankyo Full time

    About the RoleWe are seeking a highly skilled Clinical Data Management Lead to join our team at Daiichi Sankyo. As a key member of our data management team, you will be responsible for ensuring the high-quality delivery of data management services for assigned projects/studies.Key ResponsibilitiesLeadership and Direction:Develop and implement data management...

  • Clinical Data Management Lead

    5 days ago

    Basking Ridge, New Jersey, United States Daiichi Sankyo Full time

    About the RoleWe are seeking a highly skilled Clinical Data Management Lead to join our team at Daiichi Sankyo. As a key member of our data management team, you will be responsible for ensuring the high-quality delivery of data management services for assigned projects/studies.Key ResponsibilitiesLeadership and Direction: Establish data management strategies...

  • Manager Clinical Trial Information Disclosure

    2 months ago

    Basking Ridge, New Jersey, United States Daiichi Sankyo Full time

    Join a Legacy of Innovation 110 Years and CountingDaiichi Sankyo Group 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. With more than 100 years of scientific expertise and a presence...

  • Senior Director, Oncology R

    3 months ago

    Basking Ridge, New Jersey, United States Daiichi Sankyo Full time

    Join a Legacy of Innovation 110 Years and CountingDaiichi Sankyo Group 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. With more than 100 years of scientific expertise and a presence...

  • Senior Director, Oncology R&D

    3 weeks ago

    Basking Ridge, New Jersey, United States Daiichi Sankyo Full time

    Join a Legacy of Innovation 110 Years and CountingDaiichi Sankyo Group 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. With more than 120 years of scientific expertise and a presence...

  • Clinical Trial Management System Business Analyst

    1 week ago

    Basking Ridge, New Jersey, United States Centraprise Full time

    Position: Clinical Trial Management System Business Analyst (Japanese Language Proficiency Required)Location: Remote (with potential for on-site collaboration)Contract Type: Long-Term EngagementOverview:Essential Skills: Proficient in Japanese (Reading, Writing, Speaking)Core Competencies: Certification in Japanese language alongside IT...

  • Japanese Clinical Trial Management System Business Analyst

    1 week ago

    Basking Ridge, New Jersey, United States E-Solutions INC Full time

    Job OverviewPosition Title: Japanese Clinical Trial Management System Business AnalystLocation: Remote with occasional office presence required for collaborative discussions.Role Summary: We are seeking a skilled professional with a robust understanding of clinical trial systems within the healthcare and pharmaceutical sectors. The ideal candidate will...

  • Clinical Research Coordinator

    1 week ago

    Basking Ridge, New Jersey, United States Cpl Life Sciences US Full time

    Company OverviewCpl Life Science collaborates with a prominent biotechnology firm dedicated to developing life-changing therapies for individuals facing serious health challenges. Renowned for its extensive portfolio of pioneering treatments and dedication to scientific advancement, this organization has gained international recognition for its significant...

  • Clinical Research Coordinator

    1 week ago

    Basking Ridge, New Jersey, United States Cpl Life Sciences US Full time

    Company OverviewCpl Life Science collaborates with a prominent biotechnology firm dedicated to developing transformative medications for individuals facing severe health challenges. Renowned for its extensive pipeline of pioneering therapies and dedication to scientific integrity, this organization has gained international recognition for its significant...

  • Faculty Position, Oncodermatologist, Dermatology Service, Department of Medicine

    3 weeks ago

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

    The people of Memorial Sloan Kettering Cancer Center (MSK) are united by a singular mission: ending cancer for life.Informed by basic research done at our Sloan Kettering Institute, scientists across MSK collaborate to conduct innovative translational and clinical research that is driving a revolution in our understanding of cancer as a disease and improving...

  • Director, Clinical Science

    3 weeks ago

    Basking Ridge, New Jersey, United States Daiichi Sankyo Full time

    Join a Legacy of Innovation 110 Years and CountingDaiichi Sankyo Group 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. With more than 120 years of scientific expertise and a presence...

  • Director, Clinical Science

    2 months ago

    Basking Ridge, New Jersey, United States Daiichi Sankyo Full time

    Join a Legacy of Innovation 110 Years and CountingDaiichi Sankyo Group 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. With more than 100 years of scientific expertise and a presence...

Manager Clinical Safety Scientist

1 month ago

Basking Ridge, New Jersey, United States Daiichi Sankyo Full time

Join a Legacy of Innovation 110 Years and Counting

Daiichi Sankyo Group 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. With more than 120 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.

Summary
This position supports proactive safety surveillance and risk management for assigned clinical studies in partnership with Clinical Safety Scientist Product Lead, Product Safety Lead (PSL), Clinical Safety Physician(s), and cross-functional team(s) in support of benefit risk profile throughout product lifecycle. Independently leads activities without supervision for assigned clinical studies. Lead activities under the direction of Clinical Safety Scientist Product Lead. Develop expertise in one or more focus areas (SME). Involved in audits/inspections for safety surveillance and risk management for assigned clinical studies, through inspection readiness preparation

Responsibilities

Risk Management (Signal identification, evaluation, mitigation):

Supports proactive safety surveillance and risk management for assigned clinical studies in partnership with Clinical Safety Scientist Product Lead, Product Safety Lead (PSL), Clinical Safety Physician(s), and cross-functional team(s) in support of benefit risk profile throughout product lifecycleCollaborates with Clinical Safety Scientist Lead and PSL or Clinical safety physician(s) to evaluate safety data of any source to identify potential safety signals, tracks safety signals in the global electronic signal tracking tool and performs safety analysis/evaluation. May contribute to safety action recommendations, and communication and risk minimization plans. Presents assessment to the appropriate forums, including Safety Management Team (SMT) or other cross-functional teamsCollaborates with Clinical Safety Scientist Lead and PSL to develop materials (presentation, safety analyses / evaluation, etc.) for SMT/Product-level safety meetingsCollaborates with Clinical Safety Scientist Product Lead and PSL to develop minimum core product safety requirements for inclusion in Clinical study protocols (CSPs) and Informed Consent Forms (ICFs)Collaborates with Clinical Safety Scientist Product Lead and PSL to develop the Safety Management Plan for assigned product
Safety Communication:Collaborates with Clinical Safety Physician(s) for assigned clinical studies to review and revise CSPs, ICFs, Clinical Study Reports (CSRs), and review Statistical Analysis Plans (SAPs) and statistical outputs (tables, figures, and listings [TFLs]), and other clinical study documentsCollaborates with Clinical Safety Scientist Lead and PSL to author safety sections of Investigator's Brochure, aggregate reports (DSUR/PLL), Prescribing information, Company Core Data Sheet (CCDS), Risk Management Plan(s) (RMPs)Contributes to regulatory authority requests or communication for assigned clinical studiesCTD submissions/OthersMay support Common Technical Document (CTD) submissions by collaborating with Clinical Safety Scientist Lead, Clinical Safety Physician(s), PSL, and cross-functional team to develop safety strategy, key safety messages, and review and author safety sections of CTDDevelop expertise in one or more focus areasSupports Data Monitoring Committees (DMCs) and due diligence activities for assigned product(s), as neededInvolved in audits/inspections for safety surveillance and risk management for assigned clinical studies, through inspection readiness preparationProject Management:Coordinates SMT/Product-level safety meetings, maintains roster, calendar, and minutes, and communicate materials, in support of the Clinical Safety Scientist Product Lead and PSLMay serve as a project manager for other activities involving assigned product(s) or clinical studies, as neededQualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.Education Qualifications (from an accredited college or university)Bachelor's Degree at minimum requiredPharmD preferredPhD preferredExperience QualificationsPossesses scientific or therapeutic area, and drug development knowledge preferred0-1 year of experience with an advanced degree required2-3 years of experience with a Bachelor's degree requiredTravel Ability to travel up to 10%
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.