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 Leader/Associate Director Neuroscience Therapeutics 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 Leader/Associate Director Neuroscience Therapeutics, 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:
- 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.
- Plan and manage the overall execution of the assigned clinical program to meet necessary quality, budget and timelines, including making or recommending operational strategies and/or decisions (with input from Associate Directors, Clinical Operations and Regions) in support of achieving clinical program objectives; Responsible for Early Engagement process with Strategic Partners
- Matrix leader of cross-functional global Clinical Program Team responsible for operational strategy for assigned clinical program; serves as main point of contact for regional, global or cross functional issues, including any CRO/ vendor performance issues and Clinical Program Team resource issues
- Responsible for program budget planning and accountable for external spend related to program execution. Works closely with Clinical Study Manager(s), Project Management, and Finance to ensure on a regular basis that budgets, enrollment, and gaiting are accurate; Communicates program status, cost and issues to ensure timely decision-making by senior management
- Oversight of Strategic Partners/CRO/vendor selection, budget and contract negotiation, and proper supervision of performance for all activities assigned to a Strategic Partner/CRO/vendor for assigned program, including escalation of issues to governance committees when warranted; Responsible for operational risk management strategy in collaboration with Strategic Partners
- Provide program-level direction to clinical study manager(s) for the development of study management plans including enrollment models and, risk management plans, financial planning and management, communication plans, and monitoring plans in collaboration with CRO/Strategic Partner; collaborates with Associate Director, Clinical Operations to ensure inspection readiness.
- Review and provide expert clinical operations input into clinical documents related to the drug development process including Investigator Brochures, Investigational New Drug Applications (INDs) and/or Investigational Medicinal Product Dossier (IMPDs), study synopsis protocols, clinical study reports, applicable sections of the New Drug Application (NDA) and/or Marketing Authorization Application (MAA), and updates to IND and NDA documents; Provide expert clinical operations input into preparation for key regulatory meetings (e.g. End-of-Phase 2 and 3 Meetings, Request for Scientific Advice Meetings, etc.), as appropriate
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 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
- 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.