Associate Director, Clinical Safety

1 month ago

Basking Ridge, United States Daiichi Sankyo Inc. 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 safety monitoring and risk management activities, provides insights on current clinical practice and guidelines, reviews and provides written assessments of relevant medical topics, and supports PV Operations' medical review function. This position supports a senior physician in evaluating and mitigating safety signals as they arise. Additionally, this position works with other CSPV staff and cross functional Safety Management Team (SMT) members, often handling straight-forward CSPV tasks such as single event level AE causality assessment. This position requires manager review and gains industry knowledge through multiple opportunities.

Responsibilities

  • Safety Expert - Overall: Develops safety knowledge working closely with CSPV management.

  • Safety Expert - Signal Identification: Carries out routine signal identification activities formulated by manager. Uses medical knowledge to aid the SMT's signal identification efforts.

  • Safety Expert - Signal Evaluation: Assists manager in assessing new signals.

  • Safety Expert - Risk Mitigation & Communication: Communicates any safety concerns to management and relevant team members.

  • Reports and Submissions: May contribute to writing minor safety sections of the NDA, CSR, and IB. May review any safety submissions for medical accuracy.

Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education Qualifications (from an accredited college or university)

  • MD with board eligibility preferred

Experience Qualifications

  • 1 or More Years of clinical experience preferred

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.

At the heart of Daiichi Sankyo, Inc. is the fundamental belief that each employee helps shape our success. We have created an exceptional working environment that values and rewards individual contributions, but we also believe in the power of collaboration. We provide employees with the training, tools and technology that they need to excel. Our open communication, emphasis on results, and spirit of personal accountability are hallmarks of our corporate culture and ensures that each employee's unique abilities are valued and utilized. We invite you to consider a career at Daiichi Sankyo, Inc.

  • Director, Clinical Safety

    3 weeks ago

    Basking Ridge, United States Hire Talent Full time

    Job Title: Director, Clinical Safety Job Schedule: Candidate can work 100% remote for duration of assignment; might need to come into office for occasional meetings (once a quarter). Candidates need to be EST based. The Director, Clinical Safety, will be a product safety lead or part of a product safety team, and be responsible for overall product safety...

  • Director, Clinical Safety

    2 weeks ago

    Basking Ridge, United States Actalent Full time

    Job Title: Director, Clinical Safety Job Description 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...

  • Associate Director, Clinical Safety Scientist

    5 months ago

    Basking Ridge, 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 100 years of scientific expertise and a...

  • Associate Director, Clinical Science

    1 month ago

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

    Job 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...

  • Safety Leadership Director

    3 weeks ago

    Basking Ridge, New Jersey, United States Actalent Full time

    Job 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...

  • Clinical Safety Scientist Lead

    1 month ago

    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...

  • Associate Director, Clinical Science

    4 weeks ago

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

    Study 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...

  • Director, Clinical Development

    4 weeks ago

    Basking Ridge, United States Daiichi Sankyo Full time

    Director, Clinical DevelopmentJoin a Legacy of Innovation 125 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 125 years of...

  • Associate Director, Clinical Safety Scientist

    1 week ago

    Basking Ridge, NJ, United States Daiichi Sankyo, Inc. 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 100 years of scientific expertise and a...

  • Clinical Safety Scientist Lead

    3 weeks ago

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

    Job 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...

  • Clinical Science Director

    1 month ago

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

    Job 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...

  • Medical Safety Scientist

    3 days ago

    basking ridge, United States Planet Pharma Full time

    Target Pay Rate: 100-116/hr **salary will be commensurate with experience  Job Description: The Director, Medical Safety (Scientist) is a key member of the Medical Safety team. This role provides leadership, line management, and mentorship for junior Medical Safety Scientists within Medical Safety organization. In close collaboration with Medical Safety...

  • Clinical Safety Scientist Lead

    4 weeks ago

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

    Job 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...

  • Associate Director, Companion Diagnostics Lead

    4 weeks ago

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

    Job SummaryThe Associate Director, Companion Diagnostics Lead will play a key role in guiding the strategy and leading the implementation of companion diagnostics (CDx) in support of projects within Daiichi Sankyo's Early and Late-Stage Development Portfolio.This position will contribute to CDx project teams for the diagnostic, under the direction of the...

  • Associate Director, GMA Oncology

    1 month ago

    Basking Ridge, 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...

  • Regional Medical Director

    4 weeks ago

    Basking Ridge, New Jersey, United States RMA Network Full time

    Job Summary:The Regional Medical Director is a key leadership position at RMA Network, responsible for driving clinical excellence and strategy across the region. This role requires a strong clinical background, excellent leadership skills, and the ability to collaborate with cross-functional teams.Key Responsibilities:• Employ a 'servant leadership'...

  • Regional Medical Director

    4 weeks ago

    Basking Ridge, New Jersey, United States RMA Network Full time

    Job Title: Regional Medical DirectorWe are seeking a highly skilled and experienced Regional Medical Director to join our team at RMA Network. As a key member of our leadership team, you will be responsible for driving clinical excellence and overseeing the delivery of high-quality patient care in our region.Key Responsibilities:Develop and implement...

  • Clinical Director, Oncology Research

    3 weeks ago

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

    Lead 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...

  • Associate Director, Clinical Science

    3 weeks ago

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

    Study Strategy:Develops and implements the strategic direction for clinical trials, collaborating with Biostats, Data Management, and Data Operations to ensure EDC, edit checks, data quality listings, SAP, and Data Management plans are aligned with study objectives.Study Planning and Execution:Provides input on major milestones, clinical trial plans, and...

  • Associate Director, Clinical Science

    6 months ago

    Basking Ridge, 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 100 years of scientific expertise and a...