Director, Clinical Safety MD

Daiichi Sankyo US; Basking Ridge (NJ); On-site; USD 215,000 - 301,000; Full time

Job summary

An established industry player is seeking a Director of Clinical Safety to lead product safety strategies and ensure proactive risk management. This role involves collaboration with global teams to oversee safety evaluations throughout the drug lifecycle. The ideal candidate will have extensive experience in clinical safety within the pharmaceutical sector, particularly in oncology. Join a company with a rich legacy of innovation and a commitment to improving global health standards. If you are passionate about making a difference in the pharmaceutical field, this opportunity is perfect for you.

Qualifications

• 4+ years of clinical safety expertise in the pharmaceutical industry.
• Strong leadership and communication skills required.

Responsibilities

• Lead a team of physicians and scientists in product safety.
• Analyze clinical trial data for safety signals.
• Coordinate safety-related regulatory interactions.

Skills

Clinical Safety Expertise

Leadership Skills

Communication Skills

Data Analysis

Risk Management

Education

MD Board Certification

Job description

Join to apply for the Director, Clinical Safety MD role at Daiichi Sankyo US

4 days ago Be among the first 25 applicants

Join to apply for the Director, Clinical Safety MD role at Daiichi Sankyo US

Join 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 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. 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

The Director, Clinical Safety, will be a product safety lead or part of a product safety team, and be responsible for overall product safety strategy or specific areas of safety surveillance and risk management, and provide safety leadership including but not limited to clinical studies, post-marketing surveillance, signal detection and management, important safety topics, and regulatory submissions. This individual will ensure proactive safety monitoring and risk management through the Safety Management Team framework. This individual will use strong leadership and communication skills to ensure effective collaboration across development functions and sites. The individual assuming this role may function as a key member of the Global Product Team in collaboration with Clinical Development, Regulatory, Project Management, Biostatistics, Pharmacology, and other departments to strategically manage benefit-risk throughout the lifecycle of the drug. Specific responsibilities will vary depending on the stage of development of assigned projects (i.e., Phase I through commercialization).

Responsibilities

• Depending on the status of development of the compound, lead and medical-scientifically direct a team of junior physicians and scientists responsible for a compound/product safety, including project-specific training and coaching of team members and review of team output cross-functionally.
• Effectively represent the CSPV on the Global Product Team or specific sub-teams such as clinical study team and submission team, providing the safety leadership and serving as the primary point of contact.
• Review and analyze data from clinical trials, post-marketing and other relevant sources for the prompt identification of safety signals. Review and evaluate serious adverse event reports from clinical trials or post-marketing for completeness, accuracy, expectedness and relatedness.
• Lead internal and external (especially regulatory, but also expert advisory) interactions to ensure quality outcomes in the risk evaluation and management of assigned projects/products.
• Define and implement strategies and action plans for identifying and managing risks throughout the product life cycle.
• Effectively coordinate and manage available resources in developing and delivering high-quality safety evaluation related documents/deliverables on time.
• Coordinate and participate actively in safety-related regulatory interactions (e.g., regulatory meetings, post-approval commitments).
  
  

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 Board certification or eligibility required
  
  

Experience Qualifications

• Must have 4+ years of professional clinical safety expertise from pharmaceutical industry, regulatory agency or academia, with exposure to drug development, clinical pharmacology, and/or epidemiology.
  
  

Expertise in Oncology highly 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.

Seniority level

• Seniority level

  Not Applicable

Employment type

• Employment type

  Full-time

Job function

• Job function

  Health Care Provider

• Industries

  Biotechnology Research, Hospitals and Health Care, and Pharmaceutical Manufacturing

Referrals increase your chances of interviewing at Daiichi Sankyo US by 2x

Get notified about new Clinical Director jobs in Basking Ridge, NJ.

Director, Clinical Strategy and Operations

Director of Medical Excellence and Innovation

Executive Director, Clinical Development

Clinical Director, Physical Therapy - Start-Up Our Piscataway Location

Director, Medical Affairs – Antibacterials

Director, Clinical Research, Atherosclerosis

Director, Clinical Development and Medical Affairs (Respiratory)

Director of Clinical Services - Middlesex,Monmouth,Ocean Cty

Clinical Director - Outpatient Mental Health Facility

Bridgewater, NJ $215,000.00-$301,000.00 3 days ago

Executive Director, Global Medical Affairs

Director, Country Clinical Coordinator - US Medical Affairs (remote, extensive travel required)

Director, Clinical Trial Site Engagement and Participant Insights

Bridgewater, NJ $179,000.00-$250,800.00 2 weeks ago

Senior / Executive Director, US Medical Affairs Operations

Clinical Director - Outpatient Mental Health Facility

Medical Director/Scientific Director, Medical Affairs - Psychiatry

Senior Director, Clinical Science Program Lead (Neuropsychiatry)

RWJBarnabas Health is Seeking a Division Director of Infectious Disease in Newark, NJ

Clinical Director, Oncology Early Development

Senior Medical Director-Global Drug Safety

Senior Director, Clinical Research, Atherosclerosis

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.