Associate Director, Clinical Operations Program Lead

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.

ACCOUNTABILITIES:

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.

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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 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)