Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Director Research Operations in our Lexington, 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.
Oversight of US Medical Research Operations to ensure appropriate execution of the US Phase IV Company Sponsored, Collaborative Research, and Investigator Initiated Research (IIR) programs, supporting US medical strategy and Takeda integrated research plans across all therapeutic areas.
Accountable for deploying, leading, and directing a research function and ensures optimal use of internal and external resources that support all product programs. Oversees all related policies, processes, systems and budgets. This includes actively and strategically engaging internal partners to fully leverage and link into existing research operations resources.
Work collaboratively with Clinical Science Directors and Medical Directors to ensure the execution and operations of the US Medical research programs are in compliance. Provide Regulatory and GXP expertise/support to cross-functional Takeda teams. Responsible for oversight of strategic partners, CROs, contractors and various vendors to ensure consistency and to meet US Medical s goals and obligations described in ICH-GCP.
Oversee and Manage Research Operations Managers in the overall planning and execution of US Medical research to meet necessary quality, budget and timelines, including making or recommending operational strategies to achieve research objectives. Provide direction for the development of study management plans including enrollment models, risk management plans, financial planning and management, and monitoring plans in collaboration with Clinical Science Directors, Medical Directors, CROs, external research partners.
Responsible for establishing an early internal partner engagement process to ensure internal resources are leveraged and linked appropriately and responsibly, avoiding duplication or unnecessary expenses.
Oversight of Strategic Partners/CRO/vendor selection. This includes work order alignment with study parameters, budget and contract negotiation, and proper supervision of performance for all activities assigned to a Strategic Partner/CRO/vendor.
Ensure that budgets, enrollment, and gaiting are accurate and aligned with medical units.
Provide expert input into the design of study protocols across therapeutic areas to ensure operational feasibility.
Work closely with Research Operations team to collaborate with Medical Directors, MSLs and Clinical Science Directors in the process for identifying and selecting investigators for company sponsored research studies.
Provide oversight and work with Clinical Science Director to ensure the GMA research review and approval process for all IIR, clinical company sponsored, and collaborative research concepts, proposals, study reports and publications are followed.
Work closely with medical units to determine communication of data and publication plan.
Provide oversight to ensure the Medical research database and systems are managed appropriately, as required and ensure timely input related US IIR and clinical company sponsored research studies.
Collaborate with GMA on continuous operational training in US Medical to ensure efficiency of the research program and adherence to all Takeda policies and procedures.
EDUCATION, EXPERIENCE, LICENSES/CERTIFICATIONS:
Bachelor degree required, Pharmacist, PharmD, PhD or MD preferred.
10+ years combined experience in pharmaceutical industry, clinical research organization or academic research setting.
8+ yrs of clinical study management experience
Experience in managing clinical studies in at least two therapeutic areas.
A solid familiarity with the entire commercialization process and the marketplace dynamics that impact organizational decisions and deliverables.
Demonstrated understanding of the legal and regulatory guidelines associated with pharmaceutical industry research and the ability to use knowledge to make sound operational decisions
Demonstrated ability to work effectively in a matrix environment.
Proven track record of strong leadership, project management and demonstrated ability to manage, and coach cross-functional teams.
Excellent communicator, able to persuasively convey both ideas and data, verbally and in writing 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 research program budgets.
Previous clinical trial management experience in Phase II-IV
Comprehensive understanding of the pharmaceutical industry and Medical Affairs
Experience in collaborative research with academic institutions preferred
Experience in dealing with high quality key opinion leaders
Experience managing individuals with a variety of scientific and non-scientific backgrounds and training
WHAT TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution Plan
- Tuition reimbursement Company match of charitable contributions
- 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
Empowering Our People to Shine
Discover more at takedajobs.com
No Phone Calls or Recruiters Please.