Associate Director, Medical Review, MI&E - Daiichi Sankyo

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 16,000 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 Associate Director (AD) is responsible for overseeing all activities related to Medical Review for their assigned Therapeutic Area (TA). The AD is accountable for ensuring that all scientific content (e.g., promotional materials, training materials/programs, corporate communications and select medical material) is of the highest scientific quality and is compliant with all relevant policies, procedures, and regulations, for their assigned TA. The AD partners with senior colleagues in developing and implementing improvements in medical review processes and is also an integral member of the Medical Affairs Team. This position plays a key role in driving a unified medical voice across USMA functions. If the AD has direct reports, he/she is responsible for all aspects of formally managing and leading them.

Responsibilities

- Ensure timely and comprehensive review of PMR submissions. Assure all medical content meets established scientific standards and is compliant with all applicable policies and regulations. Participate in all aspects of medical review, providing expertise and guidance as lead Medical Reviewer on PMRT. Ensure appropriate early medical guidance and scientific direction is provided on promotional strategies and messaging within assigned TA including at all PMRT meetings and through ad hoc meetings with project owners. Partner with colleagues responsible for PGC medical review to ensure seamless progression of submissions from PGC to PMRT as applicable; clearly understand all PGC contingencies on PMRT materials. Within assigned TA, provide initial input and guidance to junior colleagues on any potential PMRT escalations; serve as mentor to junior colleagues
- Serve as integral member of the Medical Affairs Teams for assigned TA.Proactively lead effective coordination and alignment between medical review and other MIE and MA functionsPartner with MA staff in other functions to drive consistent interpretation of our scientific data and establish a consistent, unified medical voice/position across MA
- Lead new projects/initiatives within MIE and across functions as assigned.

- Identify and lead initiatives/projects to improve medical review function processes, output, and impact
- Lead cross-functional projects to improve MA alignment, efficiency and effectiveness
- Proactively stay abreast of and lead discussions as a functional expert on:

- Newly available clinical data and promotional content within the assigned therapeutic area
- Regulatory milestones, actions and guidance relevant to medical review activities

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 in health science required
- PharmD preferred
- Ph.D. RPh, RN acceptable

Experience Qualifications
- Minimum of 4 years in a pharmaceutical industry medical review role required
- Proven track record of working successfully with cross-functional teams to achieve results required
- Comprehensive understanding and application of relevant regulations, policies and guidances is required (e.g. OIG, FDA, PhRMA Code etc..). required
- Experience in people management (formal direct reports and/or coaching/mentoring experience) is required for ADs that will have direct reports. required

Travel

Ability to travel up to 10% Travel to scientific congress and company meetings

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.