Takeda Pharmaceuticals Associate Director, Global Medical Affairs Oncology Evidence Generation Lead in Boston, Massachusetts
About the role:
As a member of Takeda Oncology, your work will contribute to our bold, inspiring vision: We aspire to cure cancer. Here, you'll build a career grounded in purpose and be empowered to deliver your best. As part of the Global Medical Affairs team, you will report to Head of Research Global Medical Affairs Oncology and collaborating with internal and external partners.
How you will contribute:
Oversee the conduct of assigned medical affairs company sponsored studies, investigator initiated research and collaborative research planned and/or conducted in China. Provide expert guidance, consultation and support as needed to regional and Local Operating Company (LOC) medical heads and leads.
Ensure a patient-centric approach to regional and local post-registration value evidence generation by partnering closely with Oncology cross functions and regions.
Supervise and coordinate the collection, archiving and reporting of patient safety information as appropriate. Ensure coordination with Pharmacovigilance and Regulatory Affairs to respond to internal and/or external audits and requests from external regulatory bodies.
Partner with GMAO and/or regional/LOC medical heads/leads to support translation of global/regional/LOC medical strategy into executable operational plans.
Oversee the development and implementation of processes and tools to enable efficient delivery, tracking, visualization and communication of assigned studies/projects (i.e. scorecards, dashboards)
Lead the risk/issue management process and proactively collaborates with appropriate functions to deliver risk mitigation plans.
Lead the operational life-cycle management (e.g. review, approval and reporting) of assigned regional/LOC funded studies/projects (i.e. which may include one or more programs from MACs, IIR, Externally Sponsored Collaborative) which may be regional or LOC-funded. The responsibilities may include but not limited to budget planning and management, drug supply management, study tracking and archiving, systems enhancement/ upgrade/ migration, and system/ process training.
Provide strategic and functional input to the development of regional or LOC medical affairs research plans and budgets in collaboration with GMAO Evidence Generation leads, MA Region heads, LOC medical leads, alliance partners, and other internal Takeda stakeholders (e.g. Global/regional/LOC Finance).
Supervise, direct, coach, and develop study managers/associates with a focus on enterprise thinking, consistent delivery of results based on prioritization and Takeda leadership behaviors.
Oversee the tracking of assigned regional/LOC medical affairs studies/programs/projects by working closely with internal/external stakeholders and communication of key outputs, operational/performance metrics, and accomplishments. Oversee the appropriate disclosure of study related information in accordance with compliance regulations.
Bachelor's degree in relevant scientific subject required.
MSc, Pharmacist, PharmD, PhD or MD preferred
8+ years combined experience in pharmaceutical industry, academic research, or healthcare management.
3+ years of management experience in Global Medical Affairs in the planning and execution of clinical or medical affairs studies (including vendors/CRO management skills)
Awareness of key regional (e.g. China) research regulations (e.g. data privacy, intellectual property and data sharing) and industry standards
Health care business acumen with a comprehensive understanding of the pharmaceutical industry
Good communication skills and outstanding written and spoken English and Mandarin
What Takeda can offer you:
Comprehensive Healthcare: Medical, Dental, and Vision
Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
Health & Wellness programs including onsite flu shots and health screenings
Generous time off for vacation and the option to purchase additional vacation days
Community Outreach Programs and company match of charitable contributions
Family Planning Support
Flexible Work Paths
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.
n accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.