Director, Team Leader, Medical Review & Clearance
Join a Legacy of Innovation 110 Years & Counting!
With over 100 years of scientific expertise & a presence in more than 20 countries, Daiichi Sankyo & its 15,000 employees around the world draw upon a rich legacy of innovation & a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for hypertension & thrombotic disorders, under the Group's 2025 Vision to become a "Global Pharma Innovator with a Competitive Advantage in Oncology," Daiichi Sankyo research & development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart & kidney diseases, & other rare diseases.
The Director, Team Leader, MRC, MI&E, is accountable for managing and leading all MRC staff, as well as establishing and executing the goals and strategic imperatives for the MRC group. The Director oversees the full spectrum of work within the MRC function, including (but not limited to): ensuring all assets submitted into PMRT undergo timely and comprehensive medical review and that all approved assets meet established medical and scientific standards; MRC planning; collaboration with other MI&E and MA functions and other departments; staff hiring, deployment, performance and development; improving efficiencies and organizational capabilities and effectiveness; ensuring the appropriate organizational structure and governance is in place; assuring MRC staff has an integral role on all applicable committees/working groups (e.g., Medical Affairs Teams, Launch Planning Teams, Medical Product Teams, etc.). The Director partners with functional leaders across MA and other departments to align on strategic, medically informed messaging, consistent and proper data interpretation, medical positioning of products, scientifically sound promotional assets, etc...).
Oversee all MRC that is conducted by the MI&E Medical Reviewers for PMRT.
- provide ongoing guidance and input to the PMRT Medical Reviewers
- partner with leaders across functions to resolve conflicts and discordance regarding strategic direction, messaging, asset content, new initiatives etc....
- ensure seamless transition of submissions from the Programs and Grants Committee to PMRT
- maintain and refine the codified MRC Quality Review Standards.
Ensure that all Medical Reviewers rigorously drive a consistent, unified medical position/voice across US Medical Affairs (and GMA when applicable). Keep US MALT apprised of all key assets and programs and the related ongoing discussions, as appropriate and collaborate with MALT members and Therapeutic Areal Leads on issue resolution, the provision of medical guidance/consultation and strategization. Assure effective, timely knowledge and information transfer between the MRC domain and the Medical Information domain, as well as all other functions across USMA (and other departments when applicable).
Serve as Medical Affairs representative on the PMRT Steering Committee to resolve conflicts and provide early input on new, novel assets/programs/initiatives. Collaborate with Legal Affairs leadership to improve the efficiency and effectiveness of the PMRTs and build a PMRT culture that asserts accountability, compliance and quality for all reviewers, submitters and relevant functions/departments. Partner with Legal Affairs in collaborating with leadership in Commercial functions (Commercial Operations, Corporate Programs and Events, Public Affairs, Marketing, Managed Markets, Sales Training etc.) to resolve problem areas, and identify opportunities/areas for improvement regarding PMRT and related work streams.
Serve as integral member of the MI&E Governance and Leadership Team.
Lead or participate in projects/initiatives within MI&E, USMA and across functions, as assigned.
In accordance with DSI's philosophy around performance management and commitment to employee development, this position is responsible for: engaging, motivating and retaining direct reports; effectively coaching and providing ongoing feedback through formal and informal discussions; conducting Objective Setting/Development sessions; completing formal Performance Reviews; ensuring effective on-boarding and training of all newly hired employees; ardently managing and leading the MRC group; managing resources and staff deployment to balance competing demands; consistently leading by example.
Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
PharmD, PhD or MD
Minimum of 7+ years of experience in Medical Affairs with expertise in medical review of both branded and unbranded promotional and non-promotional materials/programs/initiatives. Significant experience in formal staff management and leadership is required. Proven track record of working successfully with cross-functional leaders, as well as collaborating with and influencing leadership.
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.
Director, Team Leader, Medical Review & Clearance
DSUSB Medical Affairs