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Clinical Operations Program Le...

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Job Summary

Company
Takeda
Location
Cambridge, MA
Industries
Other/Not Classified
Job Type
Full Time
Employee
Career Level
Experienced (Non-Manager)
Job Reference Code
4314_R0000662

Clinical Operations Program Leader - Late Stage Gastroenterology - Boston, MA

About the Job

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Job Description

Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as Clinical Operations Program Leader – Late Stage Gastroenterology in our Cambridge office. 

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Clinical Operations Program Leader – Late Stage Gastroenterology, you will be empowered to oversee a robust portfolio of clinical programs and their clinical studies and collaborate with our strategic partners.

POSITION OBJECTIVES:

  • You will provide operational expertise and strategic input to the development of Clinical Development Plans.
  • You will develop and lead the operational strategy on assigned programs in close collaboration with our strategic partner.
  • You will represent Clinical Operations on both the Global Program Team (GPT) and the Clinical Sub Team (CST).
  • You will provide sponsor’s oversight of our strategic partner, program-level direction and support to the clinical study manager(s) responsible for the execution of your studies.

POSITION ACCOUNTABILITIES:

  • Translate the Clinical Research Plan into an optimal operational plan
  • Plan and oversee the overall execution of the assigned clinical program(s) to meet necessary quality, budget and timelines,
  • Responsible for program budget planning and accountable for external spend related to program execution.
  • Communicate program status, cost and issues to ensure timely decision-making by senior management
  • Responsible for operational risk management strategy in collaboration with Strategic Partners
  • Review and provide expert clinical operations input into clinical documents such as Investigator Brochures,
  • Investigational New Drug Applications (INDs) and/or Investigational Medicinal Product Dossier (IMPDs), study synopsis protocols, clinical study reports
  • Ensure adequate clinical operations resources are assigned to programs
  • Support functional strategic initiatives and process improvement

EDUCATION, EXPERIENCE, BEHAVIOURAL COMPETENCIES AND SKILLS:  

  • Bachelors Degree or international equivalent required, Life Sciences preferred
  • Advanced degree is highly desirable.
  • Experience leading multiple late stage clinical trials
  • Expertise in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EUCTD, and ICH GCP. Awareness of local country requirements is also required.
  • Demonstrated excellence in project/program management and matrix leadership
  • Fluent business English (oral and written)
  • 7+ years experience in pharmaceutical industry and/or clinical research organization, including 4+ years clinical study management.
  • Experience must include Phase 2 and 3 studies and global/international studies or programs.
  • Experience in more than one therapeutic area

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.

No Phone Calls or Recruiters Please

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Locations

Cambridge, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
 

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