Director Clinical Operations

USA - 3316 Takeda Development Center Americas, Inc.; Massachusetts; Hybrid; USD 177,000 - 278,000; Full time

Job summary

Takeda is seeking a Director, Clinical Operations to lead and direct execution of multiple clinical programs within a TAU, reporting remotely to the Senior Director. The role emphasizes quality, budget and timelines with vendor oversight to meet ICH-GCP.

Requires 12+ years in pharma/CRO, 9+ years in clinical study management, global/international programs, leadership in matrix environments, and fluent business English. Travel up to 10%.

Qualifications

• 12+ years in pharmaceutical industry and/or CRO, including 9+ years in clinical study management.
• Experience in early phase or Phase 2/3 studies and global/international programs.
• Experience in more than one therapeutic area and in line management is advantageous.
• Leadership and project/program management excellence with innovative operations approaches.
• Global regulatory and compliance expertise (US CFR, EU CTD, ICH GCP).
• Awareness of local country requirements; supervisory experience.
• Fluent business English (oral and written); ability to influence without authority.

Responsibilities

• Lead and direct execution of multiple clinical programs within a TAU.
• Provide leadership and counsel for issue resolution across staff.
• Oversee program budgets and external spend with Global Program Management and Finance.
• Ensure program status communication to inform senior management decisions.
• Oversee selection and supervision of Strategic Partners/CRO/vendors.

Skills

Leadership

Program management

Cross-functional collaboration

English fluency

Influence without authority

Innovative mindset

Change management

Education

Bachelor's degree

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 a Director, Clinical Operations based remotely reporting to the Senior 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.

GOALS:

Lead and direct the execution of multiple clinical program(s) within a Therapeutic Area Unit (TAU). Responsible for line management and provides expert counsel for issue resolution, including programs assigned to other staff, when required. Provide Clinical Operations leadership under the direction of the Senior Director, Clinical Operations: Accountable for the overall execution of the assigned clinical program(s) with focus on quality, budget and timelines. Accountable for the oversight of Strategic Partners and other vendors to meet Takeda’s obligations described in ICH-GCP and Takeda’s business objectives. The assigned clinical program(s) will be large, complex, high risk and/or of business importance to Takeda or potentially a suite of programs, requiring multi-functional leadership experience and skills to achieve program goals. If a single program is assigned, the program will typically be significant in scope (e.g., multiple independent indications with individual Clinical Sub Teams (CSTs)).

ACCOUNTABILITIES:

1. Oversee COPLs assigned to represent Clinical Operations as members of the Global Program Team (GPT) and/or CST, working closely with GPT Leadership to ensure program objectives are met.


2. Represent Clinical Operations for assigned program(s) in issue escalation/awareness with senior management, e.g. functional or regional executive staff, PRC, alliance governance committees.


3. Contribute to the Clinical Development Plan(s) and associated operational strategy, in support of the Asset Strategy.


4. Accountable for program budget planning and external spend related to program execution and works closely with Global Program Management, and Finance to ensure financial accuracy.


5. Ensures communication of program status, cost and issues to inform timely decision-making by senior management.


6. Oversight of Strategic Partners/CRO/vendor selection, budget and contract negotiation, and proper supervision of performance for all activities assigned to a Strategic Partner/CRO/vendor for assigned program(s), including escalation of issues to and participation in governance committees; accountable for operational risk management strategy in collaboration with Strategic Partners.


7. Accountable for inspection readiness and provides appropriate guidance to COPLs/COMs in support of inspection activities.


8. Collaborates with and is responsible to the Senior Director, Clinical Operations to ensure adequate clinical operations resources are assigned to program(s).


9. Demonstrate advanced Takeda Leadership Behaviors and act as a role model for Takeda´s values.


10. Recognized as a clinical operations expert by other functions and ability to represent and lead cross functional initiatives.


11. May participate in Business Development/in-licensing/alliances evaluations by providing operational due diligence.


12. Able to assist in role of Senior Director, Clinical Operations as required.

EDUCATION AND EXPERIENCE:

Bachelor’s Degree or international equivalent required, Life Sciences preferred. Advanced degree is highly desirable. 12 or more years’ experience in pharmaceutical industry and/or clinical research organization, including 9+ years clinical study management. Experience must include early phase experience or Phase 2 and 3 studies and global/international programs. Experience in more than one therapeutic area and in line management is advantageous. Demonstrated excellence in leadership and project/program management, including innovative operations approaches to achieving program goals. 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. Supervisory experience. Demonstrated excellence in project/program management and matrix leadership. Excellent teamwork, organizational, interpersonal, and problem-solving skills. Fluent business English (oral and written). Able to influence without authority. 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. Support a culture of continual improvement and innovation; promote knowledge sharing.

TRAVEL REQUIREMENTS:

Requires up to 10% travel, including overnight and international travel to other Takeda sites, strategic partners, and therapeutic area required travel.

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: $177,000.00 - $278,080.00 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.