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.
- 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.
- 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
- 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