Join Takeda as a Senior Research Manager, Value and Evidence Generation out of our Lexington, MA office. Where you will partner with the Director of Clinical Research Excellence, and Medical Unit as applicable to execute and oversee US Medical Clinical Research program studies, including Investigator Initiated and Sponsored Research (IIR), Medical Company Sponsored Studies (MACS) including Clinical and HEOR, and Collaborative Studies (CCR) for multiple therapeutic areas and product programs. Manage study contracts and budgets, study documentation and study master file, approval process, and communicate study activities and status to internal stakeholders, including system management (i.e. CTMS, iEnvision).
How you will contribute:
You will be responsible for supporting IIR, CCR and MACS (Clinical and HEOR), studies within assigned TA in accordance with all applicable internal legal and compliance policies as well as external regional and country specific regulatory guidelines.
You will represents US Medical Clinical Research, Value and Evidence Generation Group when interfacing and collaborating with internal stakeholders (e.g. GMA Region and LOC medical leads, TA Medical Heads, alliance partners, etc) and external investigators to develop and execute US Medical research plans and budgets.
You may lead special projects according to USM business needs (e.g. external engagements, process optimizations).
You will assist in the execution of the US Medical research strategic and tactical plans for assigned therapeutic areas in collaboration with US Medical Value and Evidence Generation Leadership, Therapeutic Area Medical Directors, Scientific Directors, Clinical Science Lead, as applicable, and oversee allocation of the research budget.
For MACS studies you will create and Manage receipt, processing and meetings required for study concept and protocol submissions. Provide final approval outcome for research committee materials including study concepts, synopsis and protocols, meeting minutes, and team communications.
For IIR studies you will be responsible for Managing receipt and processing of study submissions for externally sponsored research. Review and work with Medical Research leadership to approve research committee materials including study concepts/synopsis and protocols, meeting minutes, and investigator communications ensuring they are scientifically sound and accurate.
You will be responsible for management, entry, quality control (QC), and validation of key data in applicable Takeda systems, per SOP requirements and processes. Support cross functional medical and research team in order to drive research forward to achieve objectives within target timelines and budget.
Bachelor's degree required, preferably in a health sciences related field with 5+ years healthcare or pharmaceutical industry experience and 3+ years of clinical research, study management and/or clinical project management.
Demonstrated understanding of the legal and regulatory guidelines associated with pharmaceutical industry research and external granting functions and the ability to use knowledge to make sound operational decisions.
Ability to communicate and interact thoughtfully, transparently, and appropriately with a variety of clients both internal and external to Takeda.
Strong understanding of finance principles and their use in managing study budgets.
An Advanced Degree in a health-related field is a plus.
Experience collaborating and indirectly managing other individuals with a variety of scientific and non-scientific backgrounds and training.
Leadership Skills & Behaviors:
Matrix project leadership required.
Proven strategic problem-solving ability and identify appropriate solutions.
Solid influencing skills and ability to negotiate in a matrix environment to optimize development and address barriers.
Highly effective written and verbal communication skills, including strong presentation skills.
Ability to execute business process transformation and implement organizational culture change.
Simultaneous management of multiple tasks of varied complexity.
Flexibility, tolerance and diplomacy to best manage change and differing opinions.
Excellent organizational skills.
Proven skills in negotiation, influencing without authority, managing through ambiguity, and working diplomatically through conflict.
Sufficient knowledge of all MS Office tools to effectively capture and communicate project information
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.
In 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.