Are you looking for a patient-focused, innovation-driven company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a SeniorDirector, Clinical Operations specializing in our Central Nervous System (CNS) therapeutic area in our Cambridge, MA office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Senior Director Clinical Operations working with the CNS team, you will be empowered to oversee a robust portfolio of clinical programs and their clinical studies and collaborate with our strategic partners. A typical day will include:
Collaborating with Regional Heads of Development Operations to define operational strategy for clinical programs, including risk management and contingency planning for clinical programs and clinical studies. Responsible for on-time, on-budget delivery of clinical trials in support of IGDP and studies.
Ensuring clinical operations process and work products are compliant with global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, local country requirements and ICH GCP.
Oversee the development of clinical operations strategy, execution and management for TDC global clinical programs in assigned therapeutic area or disease pathway or therapeutic area(s) or disease pathway(s), supporting clinical strategy defined in the Clinical Development Plan (CDP)
Responsible for functional leadership for clinical operations, including hiring, training, staff assignments, coaching, mentoring, and performance management (including compliance) in a matrix environment.
Oversees, reviews and approves operational due diligence for new compounds/alliances for budgeting, timelines, and enrollment modeling
Supports Global Development Strategic Outsourcing by leading portfolio level planning and Early Engagement process with strategic vendors in assigned therapeutic area or therapeutic areas, making recommendations for program/study allocation with strategic vendors, and participation in strategic vendor governance, including identification and resolution of performance issues.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
At least 12 years clinical study/program management experience in the pharmaceutical industry, including at least 6 years of line management experience. Experience in more than one therapeutic area and a proven track record of leadership and project management success at the director level required.
Expert knowledge of global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, local country requirements and ICH GCP.
Experience in successful change management (strategy, initiation, development and implementation of important, organization wide changes).
WHAT TAKEDA CAN OFFER YOU:
401(k) with company match and Annual Retirement Contribution Plan
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
Learn more at takedajobs.com.
No Phone Calls or Recruiters Please