Associate Director, Clinical Operations Program Lead
Takeda
August 29, 2026
Remote
United States
$154,400 - $242,550 USD yearly
Operations
Goals:
- Develop and lead program-level operational strategy and planning for assigned programs with strategic partners and vendors.
- Represent Clinical Operations at the Global Program Team (GPT) and lead the Clinical Sub Team (CST) accountable for development and execution of the CDP.
- Provide sponsor-level operational oversight to ensure studies are executed on time, with high quality, and within agreed budget.
Accountabilities:
- Translate CDP into an operational strategy/plan; assess scenarios for optimal execution; align expectations with Global Program Leader and Global Clinical Lead.
- On assigned programs, develop and lead clinical program operational strategy with Clinical Operations Managers (COMs), strategic partners, CROs, and vendors.
- Escalation point for COMs for unresolved study-level issues; oversee partner/CRO/vendor performance.
- Own budget planning and external spend for program execution; partner with COMs, Global Program Manager, and Finance to ensure budgets/enrollment are accurate.
- Participate in cross-functional process/business improvement initiatives.
- Communicate program status and issues to enable timely senior management decisions.
- Provide operational due diligence for business development/in-licensing/alliances as needed.
- Provide expert clinical operations input to clinical documents and support regulatory meetings.
- Lead Clinical Operations inspection readiness and act as SME during regulatory inspections.
- Lead/participate in cross-functional strategic initiatives and process improvement; improve efficiency and support continual improvement.
Education & Experience (Required/Preferred):
- Bachelor’s (Life Sciences preferred); advanced degree highly desirable.
- 10+ years in pharma/clinical research org; 7+ years clinical study/project management.
- Experience with early phase/Phase 2 or later phase global programs; multi-therapeutic area experience highly desired.
- Global regulatory/compliance expertise (US CFR, EU CTD, ICH GCP); awareness of local country requirements.
Skills:
- Program management (scenario/risk/contingency); matrix leadership and communication; influence without authority.
- Strong teamwork, organization, conflict resolution, problem-solving.
- Entrepreneurial/innovative, pragmatic, comfortable with ambiguity; continual improvement/knowledge sharing; fluent business English (oral/written).
- Develop and lead program-level operational strategy and planning for assigned programs with strategic partners and vendors.
- Represent Clinical Operations at the Global Program Team (GPT) and lead the Clinical Sub Team (CST) accountable for development and execution of the CDP.
- Provide sponsor-level operational oversight to ensure studies are executed on time, with high quality, and within agreed budget.
Accountabilities:
- Translate CDP into an operational strategy/plan; assess scenarios for optimal execution; align expectations with Global Program Leader and Global Clinical Lead.
- On assigned programs, develop and lead clinical program operational strategy with Clinical Operations Managers (COMs), strategic partners, CROs, and vendors.
- Escalation point for COMs for unresolved study-level issues; oversee partner/CRO/vendor performance.
- Own budget planning and external spend for program execution; partner with COMs, Global Program Manager, and Finance to ensure budgets/enrollment are accurate.
- Participate in cross-functional process/business improvement initiatives.
- Communicate program status and issues to enable timely senior management decisions.
- Provide operational due diligence for business development/in-licensing/alliances as needed.
- Provide expert clinical operations input to clinical documents and support regulatory meetings.
- Lead Clinical Operations inspection readiness and act as SME during regulatory inspections.
- Lead/participate in cross-functional strategic initiatives and process improvement; improve efficiency and support continual improvement.
Education & Experience (Required/Preferred):
- Bachelor’s (Life Sciences preferred); advanced degree highly desirable.
- 10+ years in pharma/clinical research org; 7+ years clinical study/project management.
- Experience with early phase/Phase 2 or later phase global programs; multi-therapeutic area experience highly desired.
- Global regulatory/compliance expertise (US CFR, EU CTD, ICH GCP); awareness of local country requirements.
Skills:
- Program management (scenario/risk/contingency); matrix leadership and communication; influence without authority.
- Strong teamwork, organization, conflict resolution, problem-solving.
- Entrepreneurial/innovative, pragmatic, comfortable with ambiguity; continual improvement/knowledge sharing; fluent business English (oral/written).