Locations Massachusetts - Virtual Worker Type
Employee
Worker Sub-Type
Regular
GOALS:
- Develop and lead the program-level operational strategy andplanningon assigned programs in close collaboration with our strategic partners and other vendors.
- Represent Clinical Operations at the Global Program Team (GPT) and partner with Global Clinical Lead to lead the Clinical Sub Team (CST) accountable for the development and execution of the CDP.
- Provide program-levelsponsor’soperational oversight of our strategic partners and other vendors to ensure the effective execution of the clinical studies on time, with high quality and within agreed budget.
ACCOUNTABILITIES:
- Accountable to the GPT for the translation of the CDP intoan optimaloperational strategy and plan. Ensures assessment of various scenarios operational foroptimalexecution of the CDP. Maintain close communication with the Global Program Leader and Global Clinical Lead to ensure expectations and activities are aligned.
- On assigned clinical programs, develop and lead the clinical program operational strategy in close collaboration with the Clinical Operations Managers (COMs), strategic partners, CROs, and other vendors.
- Serve as the point of escalation for the COMs for issues thatcan’tbe resolved at the study level. Collaborate with COMs and cross-functional counterparts to oversee the performance of activities assigned to our strategic partners, CROs, and other vendors.
- Responsible for budget planning and accountable for externalspendrelated to clinical program execution. Works closely with COMs, Global Program Manager (GPM), and Finance to ensure on a regular basis that budgets, enrolment, and gaiting areaccurate.
- Responsible forparticipatingin strategic cross-functional initiatives for process and/or business improvements.
- Communicates program status and issues to ensuretimelydecision-making by senior management.
- Mayparticipatein Business Development/in-licensing/alliances evaluations by providing operational due diligence.
- Review and provide expert clinical operations input into clinical documents related to the drug development process and into preparation for key regulatory meetings asappropriate.
- Leads Clinical Operations aspects of inspection readiness activities and acts as subject matter expert during regulatory inspections.
- Lead orparticipatein cross-functional strategic initiatives and process improvement.
- Actively seek new ways of working more efficiently to meet the needs of clinical development.
- Demonstrate advanced Takeda Leadership Behaviors and act as a role model for Takeda´s values.
EDUCATION AND EXPERIENCE:
- Bachelor’s Degree or international equivalent required, Life Sciences preferred. Advanced degree is highly desirable.
- 10 or more years’ experience in pharmaceutical industry and/or clinical research organization, including 7 or more years clinical study/project management.
- Experience must include early phase clinical studies/Phase 2 studies or later phase global programs.
- Experience in more than one therapeutic area is highly desired.
- Expertise inglobal 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 alsorequired
- Demonstrated excellence in program management, including scenario assessment, riskassessmentand contingency planning
- Demonstrated excellent matrix leadership and communication skills
- Able to influence without authority
- Excellent teamwork, communication, organizational, interpersonal, conflict resolution and problem-solving skills
- Entrepreneurial and innovative; takes measured risks;thinks outside the box;challengethe status quo
- Pragmatic and willing to drive and support change
- Is comfortable with ambiguity
- Embody a culture of continual improvement and innovation; promote knowledge sharing
- Fluent business English (oral and written)
$154,400.00 - $242,550.00
Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
Job Description
Are you looking for a patient-focused, innovation-driven company to inspire you and empower you to shine? Join us as an Associate Director, Clinical Operations Program Lead, Oncology based remotely reporting to the Executive Director, Clinical Operations, Oncology.
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to work towards their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, and work toward excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world.
Here, you will be a necessary contributor to our inspiring, bold mission.