Associate Director, Medical Review PGC

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 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. 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 AD is responsible for overseeing all activities related to the Medical review and clearance of all submissions to the Programs and Grants Committee (PGC). The AD is accountable for ensuring that all approved assets/programs/projects meet our established medical and scientific standards. The AD partners with colleagues responsible for Medical Review and Clearance of PMRT assets to ensure seamless progression of applicable submissions that get submitted to PMRT review after PGC approval. The AD plays a key role in early planning with PMRT reviewers, ensuring that all PGC contingencies are clearly understood by PMRT Medical Reviewers, driving the cross-functional assessment of program implications for Medical Affairs and ensuring alignment across the department and other functions as needed.

Responsibilities

• Ensure comprehensive Medical Review of PGC submissions:
  • Conduct pre-review of PGC submissions prior to the PGC meetings and communicate to the PGC Coordinator if additional information is needed from the requestor
  • Review PGC requests for completeness and alignment with applicable policies
  • Attend PGC meetings and ensure that Medical Review is conducted in a timely manner; provide consultation specific to Medical concerns
  • Ensure that all approved submissions meet our established medical and scientific standards
  • Escalate program requests to MA Leadership as appropriate/needed
  • Collaborate with PGC Legal and Compliance to discuss submission and develop necessary contingencies/requirements for approval; collaborate with Compliance on programs taking place outside the US
• Drive collaboration and connectivity with MA colleagues on other relevant committees.
  • Proactively review new submissions that will impact PMRT with PMRT Medical reviewers.
  • Lead the necessary planning and coordination as well as business impact analyses with colleagues from MA and other functions.
  • Attend PMRT meetings as needed to ensure seamless management and transition of submissions from PGC to PMRT
  • Attend PGC Steering Committee Meetings as needed.
• Drive Medical Affairs’ excellence in Medical review for PGC.
  • Develop and disseminate PGC reports/metrics
  • Establish and maintain written Medical Review standards
  • Assist Head of MI&E with resource allocation/deployment
  • Partner with MA leadership to develop and support medical strategies related to PGC activities
  • Cross-train other MI&E staff as needed
• Collaborate with Legal Affairs and Compliance on improving the processes and operations of the PGC and leading the enhancement and revision of PGC policy and associated procedures.
  • Train MA colleagues on changes in PGC policy and procedures
  • Identify ways to refine the hand-off process to PMRT teams
  • Collaborate with OG&E on submission transfer when applicable

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)

• Master's Degree from an accredited college or university required
• PharmD preferred
• PhD preferred

Experience Qualifications

• 4 or More Years of experience in a pharmaceutical industry Medical Affairs role including significant experience in medical review and clearance preferred
• Proven track record of working successfully with cross-functional teams to achieve results preferred
• Comprehensive understanding and application of relevant laws, regulations, policies and procedures is required (e.g. OIG, FDA, PhRMA Code etc..) preferred
• Substantial experience in effectively collaborating with others in leadership roles required

TravelAbility to travel up to 5% Domestic travel

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.