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Senior Director, Clinical Operations

Location
North Marshfield, Massachusetts
Job Type
Permanent
Posted
3 Sep 2022

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Job Description

Are you looking for a patient-focused company to 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 reporting to the Head of Global Clinical Operations based in our Cambridge/Lexington office or hybrid.

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 work towards their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, and work towards 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.

GOALS:

  • Oversee clinical operations strategy, execution and management of 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).
  • Manage Global Clinical Operations financial planning/forecasting and budget management for assigned therapeutic area or therapeutic areas. Oversee administrative budget oversight for direct and indirect reports.
  • Represent Global Clinical Operations as primary contact for therapeutic area, company partners and Strategic Partners and vendors.
  • Lead the development of Clinical Operations processes and creating the support for unified approaches across therapeutic areas.
  • Develop and lead in global programs representing Clinical Operations to support Takeda R&D goals.

ACCOUNTABILITIES:

  • Collaborate with global functional heads and TA leadership to define operational strategy for clinical programs, including risk management and contingency planning for clinical programs and clinical studies. Manage on-budget delivery of clinical trials.
  • Ensure clinical operations process and work product is compliant with global regulatory and compliance requirements for clinical research, including US CFR, EU CTD, local country requirements and ICH GCP.
  • Manage clinical operations staff.
  • Oversee clinical budget planning/forecasting and management for assigned therapeutic area.
  • Oversee and approve operational due diligence for new compounds/alliances for budgeting, timelines, and enrollment modeling.
  • Maintain current therapeutic area knowledge and assess impact of new information on operational strategies.
  • Escalate issues related to quality, timelines and budget and provide recommendations to upper management for resolution of these issues.
  • Support strategic outsourcing by participating in strategic vendor governance, including identification and resolution of performance issues.
  • Lead plans for process, technology or other continuous improvement to achieve cost-reduction, time-savings, efficiency, quality and other goals.
  • Manage functional leadership in global clinical operations, including both direct line management (hiring, training, staff assignments, mentoring, and performance management) and management of global clinical operations staff in a matrix environment.

EDUCATION AND EXPERIENCE:

  • Bachelor's Degree or international equivalent required, Life Sciences preferred. Advanced degree desirable.
  • 15+ years' experience in pharmaceutical industry or clinical research organization, including 12+ years clinical study/program management, including at least 6 years of line management experience.
  • Experience in more than one therapeutic area and experience in leadership and project management success at the director level required.
  • Experience in global regulatory and compliance requirements for clinical research, including 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).
  • Previous line management or direct management of team members.

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

Location and Salary Information:

  • Location(s): Cambridge, MA, Lexington, MA, or hybrid.
  • Base Salary Range: $230,000 - $280,000 based on candidate professional experience level.

Empowering Our People to Shine

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EEO Statement

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.

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
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Details

  • Job Reference: 703156357-2
  • Date Posted: 3 September 2022
  • Recruiter: Takeda Pharmaceutical
  • Location: North Marshfield, Massachusetts
  • Salary: On Application
  • Sector: Executive Positions
  • Job Type: Permanent