Senior Director, Oncology R&D Functional Excellence

4 days 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 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

A cross-Oncology Development Medical Doctor position reporting to the Head Clinical Development Functional Excellence. This position complements CSPV and GMA efforts with a comprehensive and all-encompassing approach to coordinate activities, under the leadership of the Head of Functional Excellence, across key functions to improve the benefit-risk in patients treated within the oncology compounds throughout the course of clinical development through the commercial setting. In this role, the incumbent will contribute to creation and improvement of Clinical Development processes.

Job Description:

  • Execute an overarching safety program tailored for AEs from end-to-end: understanding predisposing non-clinical and clinical factors, diagnosis, effective management during clinical trials and beyond in post approval setting.
  • Responsible for the execution of key safety initiatives aimed at preventing, mitigating, and addressing critical safety issues including but not limited to protocol amendments, Dear HCP letters and key medical education initiatives.
  • Develops prospective contingency plans for management of assigned safety risks across projects; Clearly defines priorities and high-level execution plans across and effective alignment within (e.g. with translational research, clinical operations, clinical development, medical affairs CSPV and other internal groups) and outside of Daiichi Sankyo (e.g. clinical trial sites, CROs, collaboration partners); Supports effective direct communication with clinical sites in collaboration with clinical development staff.
  • Consults with KEE’s for advice on complex patient safety issues. Communications lead with HCP’s (PI’s, sub- PI’s, nurses) at the site level to ensure that patient safety with respect to the safety risk assigned remains top of mind in the context of patient management in the clinical trial setting and in the real-world setting.
  • Contributes to creation and improvement of Clinical Development processes.

Education:

  • MD required; prefer Board certification in Oncology.

Experience:

  • At least 7 years of experience in pharmaceutical industry.
  • At least 2 years in Patient Safety.
  • At least 2 years of experience in Clinical Development.
  • At least 2 years of Oncology experience.

Competencies:

  • An impeccable oncology clinical and medical expert with proven credibility and experienced in patient safety and clinical development.
  • Experience working in a matrix environment and on cross-functional teams.

Travel requirements: Local and global travel might be required up to 20%

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.

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