Associate Director, Clinical Operations Program Lead (COPL)

Takeda

36d•Remote

About The Position

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description OBJECTIVES: 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. 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.

Requirements

Bachelor’s degree or international equivalent required, Life Sciences preferred. Advanced degree is highly desirable.
10+ years’ experience in pharmaceutical industry and/or clinical research organization, including 7+ 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)
Requires up to 10 % travel, including overnight and international travel to other Takeda sites, strategic partners, and therapeutic area required travel.

Nice To Haves

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

Responsibilities

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.

Benefits

U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.
U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

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