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 a Senior Clinical Operations Program Manager Late Stage Neuroscience Therapeutic in our Cambridge office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Senior Clinical Operations Program Manager Neuroscience Therapeutic , 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:
- 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.
- 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, including Neuroscience Therapeutics
- 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
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
No Phone Calls or Recruiters Please.