Associate Director, Clinical Operations Program Lead

USA - 3316 Takeda Development Center Americas, Inc.; Massachusetts; Hybrid; USD 154,000 - 243,000; Full time

Job summary

Takeda seeks an Associate Director, Clinical Operations Program Lead, Oncology to oversee program-level operational strategy for oncology studies. This remote role reports to the Executive Director and requires global collaboration with partners and vendors to deliver on-time, high-quality studies within budget.

The candidate will lead cross-functional teams, ensure regulatory compliance, and drive continuous improvement in clinical operations across multiple therapeutic areas.

Qualifications

• Bachelor’s Degree or international equivalent required, Life Sciences preferred.
• Advanced degree is highly desirable.
• Experience: 10+ years in pharma/ CRO, including 7+ years in clinical study/project management.
• Experience in early phase studies or later global programs.
• Experience in more than one therapeutic area is highly desired.
• Expertise in global regulatory and compliance requirements for clinical research (US CFR, EU CTD, ICH GCP).
• Fluent business English (oral and written).

Responsibilities

• Translate CDP into an optimal operational strategy and plan.
• Lead the clinical program operational strategy with COMs, CROs, and vendors.
• Oversee budgets and external spend related to clinical program execution.
• Collaborate with cross-functional teams to ensure timely, high-quality studies.
• Prepare regulatory documents and participate in key regulatory meetings as appropriate.
• Demonstrate leadership, adapt to changing environments, and drive process improvements.

Education

Bachelor’s Degree or international equivalent

Advanced degree

Job description

Job Description

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.

Goals

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.

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).

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Massachusetts - Virtual U.S. Base Salary Range: $154,400.00 - $242,550.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

Equal Opportunity Employer

Takeda is an equal opportunity employer.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

• Massachusetts - Virtual
• Worker Type: Employee
• Worker Sub-Type: Regular Time
• Type Job Exempt Yes
• It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.