Job Description

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as Associate Director, GMA Evidence Generation Operations in our Cambridge, MA office.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Here, you will be a vital contributor to our inspiring, bold mission.

As Associate Director, GMA Evidence Generation Operations working on the Evidence Generation team, you will be empowered to oversee and manage the activities of Global Medical Evidence Operations managers, including the initiation, tracking, completion, and reporting of studies. A typical day will include:

POSITION OBJECTIVES:

Oversee and manage the activities of Global Medical Evidence Operations managers, including the initiation, tracking, completion, and reporting of studies.
Manage all aspects of assigned program including Medical Affairs Company Sponsored Studies (MACS), Investigator Initiated Research (IIR), and Externally Sponsored Collaborative Clinical Research (CCR) studies for assigned therapeutic areas and product programs.
Manage TA and product level study budgets. Manages all finance related aspects for global studies – invoicing, accruals and forecasting.
Responsible for the conduct of studies in accordance with all applicable internal legal and compliance policies (SOPs) as well as external regional and country specific regulatory guidelines.
May serve as the therapeutic operational area lead for interfacing with internal stakeholders (e.g. GMA, Region and LOC medical leads, TA Medical Heads, alliance partners, etc.) and external investigators to develop and track research plans and budgets.  
Support training of managers and regions/LOCs on MACS, Collaborative Research and IIRs.

POSITION ACCOUNTABILITIES:

Facilitate receipt, processing, and internal cross-functional review of internal/external study submissions 
Review research committee materials including study concepts and protocols, meeting minutes, and investigator communications for completeness, alignment to strategy and Takeda`s policies, as applicable.
Lead required cross-functional review meetings to review, approve, and track studies and ensure proper documentation and archiving (minutes, team communications, etc.) of review outcomes.
Coordinate the capture, archiving and reporting of appropriate study level information (including patient safety information) and deliverables. Communicate study activities to internal stakeholders.
Facilitate the management of the internal iEnvision (or equivalent system) and document repositories per Medical Affairs SOPs and processes.
Coordinate with Pharmacovigilance and Quality to respond to external audits, CAPAs and requests from external regulatory bodies.
Perform vendor management, including contract co-ordination
Contribute to pre- fair market value (FMV) evaluation of proposed study budget and oversee the conduct of FMV assessments of budgets submitted for approved studies in accordance with Takeda policies and procedures.
Lead process improvement initiatives and contributes to the development and updates of SOP, Job Aids and system upgrades

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:

Minimum MSc degree required (preferably PhD), preferably in a health sciences related field with 6 years of research related experience and/or pharmaceutical industry experience.
Experience with late stage clinical studies, research collaborations and RWE
Proven track record of strong leadership, project management and demonstrated ability to coach and mentor individuals.
Ability to communicate and interact thoughtfully, transparently, and appropriately with a variety of stakeholders both internal and external to Takeda.
Experience overseeing work of and mentoring other individuals with a variety of scientific and non-scientific backgrounds and training
Experience working in a global organization and within matrix structure highly desirable.