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 Sr. Clinical Operations Program Manager /Clinical Operations Program Manager in Early Clinical Operations
in our Cambridge office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Sr. Clinical Operations Program Manager / Clinical Operations Program Manager
working in the Early Clinical Operations 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: OBJECTIVES:
- You will provide operational expertise and strategic input to the development of Early Clinical Research Plans (ECRPs).
- 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.
Qualifications: EDUCATION, EXPERIENCE, BEHAVIOURAL COMPETENCIES AND SKILLS: Education:
- Translate the Early Clinical Research Plan into an optimal operational plan
- Plan and oversee the overall execution of the assigned early 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
- Act as a role model for Takeda´s values
- 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)
8+ years experience in pharmaceutical industry and/or clinical research organization, including 5+ years clinical study management. Experience should include early phase studies and global/international studies or programs. Experience in more than one therapeutic area is required. Physical demands include:
manual dexterity required to operate office equipment (i.e. computers, phones, etc.). TRAVEL REQUIREMENTS:
WHAT TAKEDA CAN OFFER YOU:
- Requires approximately 10-20 % travel, including overnight and international travel to other Takeda sites, strategic partners, and therapeutic area required travel.
Empowering Our People to Shine
- 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
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.
A little about us:
Takeda fosters an inclusive environment where all employees are empowered to shine.