Are you looking for a patient-focused, innovation-driven 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 Clinical Program Manager/Senior Clinical Program Manager specializing in Early Development Oncology therapeutic area in our Cambridge, MA office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Clinical Program Manager/Senior Clinical Program Manager working with the Early Development Oncology team, 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 lead and direct execution of clinical studies for an assigned clinical program, supporting clinical strategy defined in Clinical Study Plan (CSP) in support of the Integrated Global Development Plan (IGDP).
You will working in close collaboration with Clinical Operations Managers, where you will be responsible for execution of studies in assigned clinical program in compliance with quality standards (including ICH GCP, local regulations and Takeda SOPs), on schedule and on budget.
You will provide oversight of our strategic partners and other vendors to meet Takeda s obligations described in ICH-GCP and Takeda s business objectives.
- Enjoy the key learnings as you represent Clinical Operations globally as a member of the Global Development Team, working closely with Leadership to ensure program objectives are met, You will also be asked to represent Clinical Operations for assigned program in issue escalation/awareness with senior management, e.g. regional executive staff, GMC, alliance governance committees
- Other responsibilities include program budget planning and external spend management related to program execution. You will work closely with Clinical Study Manager(s), Project Management, and Finance to ensure on a regular basis that budgets, enrollment, and gaiting are accurate.
- Key opportunities for you to oversee our Strategic Partners/CRO/vendor selection, budget and contract negotiation, and supervise performance for all activities assigned to a Strategic Partner/CRO/vendor for assigned program, including escalation of issues to governance committees when warranted.
- 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.
- You will also 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
- Act as a role model for Takeda s values
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
Education: 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, EU CTD, and ICH GCP. Awareness of local country requirements is also required.
- Demonstrated excellence in project/program management and matrix leadership
- Excellent teamwork, organizational, interpersonal, and problem solving skills
- Fluent business English (oral and written)
Experience: We are looking for 7+ years experience in pharmaceutical industry and/or clinical research organization, including 4+ years clinical study management. Your experience should include Phase 1 and 2 studies and global/international studies or programs. And your experience in more than one therapeutic area, including Oncology, is highly desired.
- Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
- 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.
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
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