Senior Director Clinical Operations - CNS
Location:
Cambridge , Massachusetts
Posted:
December 12, 2017
Reference:
1701041


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 Senior Director, 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)


  • Initiating, developing and leading global (cross-regional) initiatives representing Clinical Operations in support of both Global Clinical Operations and Takeda R&D cross functional drug develop objectives.



Responsibilities


  • Responsible for Global Clinical Operations financial planning/forecasting and budget management for assigned therapeutic area or therapeutic areas. Responsible for administrative budget oversight for direct and indirect reports.


  • Represents Global Clinical Operations at therapeutic area or disease pathway level as primary point of contact for therapeutic area or disease pathway Heads, internal stakeholders and Strategic Partners and vendors


  • Responsible for functional leadership for clinical operations, including hiring, training, staff assignments, coaching, mentoring, and performance management (including compliance) in a matrix environment.


  • Responsible for leading the development of consistent Clinical Operations processes and creating the support for unified approaches across Disease Pathways /Therapeutic Areas


  • Direct management of Clinical Program Managers and Associate Directors, Study Management (who manage clinical study managers).


  • 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.




Qualifications:


EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:


  • Bachelors Degree or international equivalent required, Life Sciences preferred. Advanced degree highly desirable.


  • 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.


  • Global/International experience required, including ability to manage intercultural regionally based teams and fluent business English skills (oral and written).


  • Experience in successful change management (strategy, initiation, development and implementation of important, organization wide changes).



TRAVEL REQUIREMENTS:
  • Requires approximately 10-20 % travel, including overnight and international travel to other Takeda sites, strategic partners and therapeutic area required travel.


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



Learn more at takedajobs.com.

Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visit http://www.takeda.us/careers/EEO_Policy_Statement.aspx

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