Associate Director, Clinical Operations Program Lead

Takeda•USA - MA - Virtual, MA

1d•$154,400 - $242,550•Remote

About The Position

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.

Requirements

Bachelor’s Degree or international equivalent required, Life Sciences preferred.
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.
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 program management, including scenario assessment, risk assessment and 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; challenge the 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)

Nice To Haves

Advanced degree is highly desirable.
Experience in more than one therapeutic area is highly desired.

Responsibilities

Develop and lead the program-level operational strategy and planning on 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-level sponsor’s operational 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.
Accountable to the GPT for the translation of the CDP into an optimal operational strategy and plan.
Ensures assessment of various scenarios operational for optimal execution 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 that can’t be 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 external spend related 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 are accurate.
Responsible for participating in strategic cross-functional initiatives for process and/or business improvements.
Communicates program status and issues to ensure timely decision-making by senior management.
May participate in 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 as appropriate.
Leads Clinical Operations aspects of inspection readiness activities and acts as subject matter expert during regulatory inspections.
Lead or participate in 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.