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 is seeking an Associate Director, Clinical Operations Program Lead (remote) reporting to the Executive Director, Clinical Operations. The role drives program-level operational strategy, vendor oversight, and cross-functional alignment across global teams from the Massachusetts/virtual base.

Must have 10+ years in pharma/ CRO, 7+ in PM, and strong regulatory knowledge, with fluent business English. Massachusetts Virtual location supports flexible work arrangements within the U.S. workforce.

Qualifications

• Bachelor’s degree or international equivalent required, Life Sciences preferred.
• 10+ years’ experience in pharmaceutical industry and/or clinical research organization, including 7+ years clinical study/project management.
• Experience in 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 US CFR, EU CTD, and ICH GCP.
• Fluent business English (oral and written).

Responsibilities

• Develop and lead the program-level operational strategy and planning.
• Represent Clinical Operations at the Global Program Team (GPT) and lead the Clinical Sub Team (CST).
• Provide program-level sponsor’s operational oversight of partners and vendors.
• Budget planning and accountability for external spend on clinical program execution.
• Lead cross-functional initiatives for process and/or business improvements.
• Communicate program status to senior management.

Skills

Leadership

Program management

Budget management

Cross-functional collaboration

Regulatory knowledge

Communication

Education

Bachelor's degree in Life Sciences

Advanced degree desired

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 based remotely reporting to the Executive Director, Clinical Operations. 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. 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.

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.

EDUCATION AND EXPERIENCE

• 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.
• 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.
• Embod e a culture of continual improvement and innovation; promote knowledge sharing.
• Fluent business English (oral and written).

Compensation and Benefits Summary

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.

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 Full time 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.

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own. Takeda is an equal opportunity employer.