The mission of Daiichi Sankyo Cancer Enterprise is to leverage our world-class, innovative science and push beyond traditional thinking to create meaningful treatments for patients with cancer. We are dedicated to transforming science into value for patients, and this sense of obligation informs everything we do. Anchored by three pillars including our investigational Antibody Drug Conjugate Franchise, Acute Myeloid Leukemia Franchise and Breakthrough Science, we aim to deliver seven distinct new molecular entities over eight years during 2018 to 2025. Our powerful research engines include two laboratories for biologic/immuno-oncology and small molecules in Japan, and Plexxikon Inc., our small molecule structure-guided R&D center in Berkeley, CA.
The Director Global Medical Affairs Oncology (GMA), ADC, under the direction of the Senior Director, (Global Medical Affairs team lead for compound), is responsible for assisting with defining compound/program medical strategies and for leading select medical affairs projects within a specific compound or indication.
Leads the development of the Global Medical Affairs strategy and execution of the Global Medical Affairs plan for select indications/projects related to evidence generation, medical information and internal education, publications, scientific exchange and external data communication, and stakeholder scientific engagement. Responsible for managing budgets and resources for the assigned GMA plan activities, in collaboration with Sr. Director.
Leads medical readiness activities for market launches and life cycle management for select indications/projects. Gains strategic and planning alignment across regions and functions and supports review of Local Country/Regional Medical Affairs activities when applicable. Provide medical support/input into commercial and market access discussions for select indications.
Serve as medical lead for select company-sponsored GMA evidence generating studies/projects. Manages all medical aspects such as study document development and drives execution for assigned projects in collaboration with GMA Clinical Operations and other cross-functional and regional stakeholders.
Provides support in review of investigator-initiated studies (IIS) and may serve as deputy compound lead in Global IIS Review Committee meetings.
Leads external medical education and other scientific exchange activities in alignment with the Senior Director, such as scientific symposium and medical congresses, within legal and compliance regulations.
Collaborates across functions to support GMA MI&E activities in order to achieve approval of key scientific communications resources such as medical information response documents, (non-) promotional materials, educational slide deck and other internal training resources, within legal and compliance regulations. Provide training or communication of emerging data (internal or competitive), such as congress updates and development program highlights.
Provides medical leadership in interactions with key external stakeholders and lead Scientific Engagement activities such as planning advisory boards, managing individual stakeholder interactions and peer to peer discussions, congress engagement activities, and collation of insights for select indications related to the compound.
Provides support in the review of GMA Publications (abstracts, presentations, and manuscripts) and may serve as deputy compound lead on the Publication Planning Subteam (PPS).
Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
PhD and/or PharmD from an accredited college or university required, or MD
Advanced knowledge in medical/scientific area (Oncology) required
10 years' overall relevant experience; 5 years' experience in pharma at local, regional and/or Global level.
Excellent knowledge of current clinical practice in Oncology / Hematology / Endocrinology or other relevant disease area.
Must possess strong knowledge in and understanding of medical activities (including scientific communications, medical information, MSLs, and HEOR), relating to the commercialization of oncology products
Demonstrates strong scientific expertise within assigned therapeutic area(s) within the franchise.
Effectively manages activities and optimize resources and budget to meet business needs; have excellent project management skills
Build strong internal and external relationships with diverse stakeholders to maximize alignment and organizational effectiveness
Conduct medical/legal review
Operational knowledge and experience in prospective and/or retrospective study design and all stages of study conduct (Start-up, Execution, Analysis, Reporting)
Effectively engage external stakeholders across a broad range of audiences and activities such as evidence generation projects, publications, medical information and education, Advisory Boards, Scientific Exchange)
Provide training to internal customers
Review scientific communications resources and publications
Expertly manage ambiguity and highly complex situations
Have excellent communications skills and ability to convey complex scientific concepts simply and effectively
Internal Project and Budget Accountability
Fluent English (oral and written)
Ability to travel 15-30% including domestic and international.
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.
Job Title Director GMA Oncology- ADC
City Basking Ridge
Functional Area Global Medical Affairs Oncology
State New Jersey Associated topics: ancmg, breast, cancer, hem onc, hematology, lah, oncology, physician md, physician md do, thedacare
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.