Associate Director Clinical Operations Program Lead
About The Position
Takeda is seeking an Associate Director, Clinical Operations Program Lead to develop and lead operational strategy and planning for assigned clinical programs. The role represents Clinical Operations on the Global Program Team and partners with the Global Clinical Lead to lead the Clinical Sub Team responsible for developing and executing the Clinical Development Plan (CDP). It provides program-level sponsor oversight of strategic partners and vendors to support timely, high-quality clinical study execution within agreed budgets. The position works closely with Clinical Operations Managers, strategic partners, CROs, vendors, the Global Program Leader, the Global Clinical Lead, the Global Program Manager, and Finance. It is responsible for program-level planning, escalation management, external spend oversight, status communication, clinical operations input into development documents, and inspection readiness. The role may also support business development, in-licensing, and alliance evaluations through operational due diligence, and contribute to cross-functional process and business improvement initiatives. The position is remote and reports to the Executive Director, Clinical Operations. The listed U.S. base salary range is $154,400 to $242,550. The actual offer may vary based on qualifications, experience, skills, education, credentials, and work location.
Requirements
- Bachelor’s degree or international equivalent; Life Sciences preferred.
- At least 10 years of experience in the pharmaceutical industry and/or a clinical research organization, including at least 7 years in clinical study or project management.
- Experience with early-phase clinical studies, Phase 2 studies, or later-phase global programs.
- Expertise in global regulatory and compliance requirements for clinical research, including US CFR, EU CTD, and ICH GCP.
- Awareness of local country requirements.
- Demonstrated program-management excellence, including scenario assessment, risk assessment, and contingency planning.
- Demonstrated matrix leadership and communication skills, with the ability to influence without authority.
- Excellent teamwork, communication, organizational, interpersonal, conflict-resolution, and problem-solving skills.
- Fluent business English, written and oral.
- Entrepreneurial and innovative approach; willingness to take measured risks, think creatively, and challenge the status quo.
- Pragmatic approach and willingness to drive and support change.
- Comfort with ambiguity.
- Commitment to continual improvement, innovation, and knowledge sharing.
Nice To Haves
- Advanced degree is highly desirable.
- Experience in more than one therapeutic area is highly desired.
Responsibilities
- Develop and lead program-level operational strategy and planning in collaboration with strategic partners and vendors.
- Represent Clinical Operations on the Global Program Team and partner with the Global Clinical Lead to lead the Clinical Sub Team responsible for developing and executing the CDP.
- Translate the CDP into an operational strategy and plan, assess execution scenarios, and align expectations and activities with the Global Program Leader and Global Clinical Lead.
- Develop and lead clinical program operational strategy in collaboration with Clinical Operations Managers, strategic partners, CROs, and other vendors.
- Serve as an escalation point for Clinical Operations Managers when issues cannot be resolved at the study level.
- Collaborate with Clinical Operations Managers and cross-functional counterparts to oversee strategic partner, CRO, and vendor performance.
- Plan budgets and oversee external spend for clinical program execution; work with Clinical Operations Managers, the Global Program Manager, and Finance to maintain accurate budgets, enrollment, and gating.
- Participate in strategic cross-functional process and business improvement initiatives.
- Communicate program status and issues to support timely senior-management decisions.
- Provide operational due diligence for business development, in-licensing, or alliance evaluations as needed.
- Review clinical development documents and provide expert clinical operations input, including for preparation for key regulatory meetings as appropriate.
- Lead Clinical Operations inspection-readiness activities and act as a subject matter expert during regulatory inspections.
- Seek more efficient ways of working to meet clinical development needs.
- Demonstrate Takeda Leadership Behaviors and serve as a role model for Takeda’s values.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
