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Director Clinical Operations Program Leader

Boston, Massachusetts


Takeda fosters a collaborative and stimulating work environment filled with opportunity and the chance to make a difference in people's lives. It is a workplace driven by integrity, one of Takeda’s long-held values that extends to both the patients we serve and our employees who develop and deliver medicines. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole.

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Director Clinical Operations Program Leader

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Job ID R0013015 Date posted 10/16/2019 Location Boston, Massachusetts

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Job Description

osition Title: Director, Clinical Operations Program Leader (COPL)

Function: Global Development Operations

Department: Clinical Operations 

Reports To (Position

Title): Senior Director, Clinical Operations

Owner: Melanie Ivarsson

Last updated: XXJul2019

Job Code: · 60099270


(Briefly summarize the overall purpose of the position.  Objectives should be written in 3 – 4 statements).

Lead and direct the execution of clinical program(s) within a Therapeutic Area (TA); contribute to the Clinical Development Plan and associated operational strategy, in support of the Asset Strategy.   

Provide Clinical Operations leadership under the direction of the Senior Director Clinical Operations:

· Lead and manage multiple clinical programs within the TA through the direct supervision of additional Clinical Operational Leaders 

· Accountable for the execution of assigned clinical program(s) in compliance with quality standards (including ICH GCP, local regulations and Takeda SOPs), on schedule and on budget.

· 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).  The Director, Clinical Operations Program Leader will also take on functional leadership responsibilities including line management, providing expert consult for issue resolution and assisting the Director/Senior Director of operations.  


(Describe the primary duties and responsibilities of the job.  Approximately 5 – 10 task statements should be identified).

· Oversee the overall execution of the assigned clinical program(s) with focus on quality, budget and timelines, including making decisions or recommending operational strategies in support of achieving clinical program objectives

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

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

· Accountable for program budget planning and external spend related to program execution.  Works closely with Global Program Management, and Finance to ensure budgets, enrollment, and gaiting are accurate; ensures communication of program status, cost and issues to inform timely decision-making by senior management

· 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 when warranted; accountable for operational risk management strategy in collaboration with Strategic Partners

· Provide TA-level direction to COPLs/APLs for the development of operational plans including enrollment models and , risk management plans, financial planning and management, communication plans, and monitoring plans in collaboration with CRO/Strategic Partner; accountable for inspection readiness.

· Provide TA-level direction and/or contribute directly to due diligence projects across the therapeutic area.

· Accountable for the review and expert clinical operations input into clinical documents related to the drug development process including Investigator Brochures, Investigational New Drug Applications (INDs) and/or Investigational Medicinal Product Dossier (IMPDs), study synopsis protocols, clinical study reports, applicable sections of the New Drug Application (NDA) and/or Marketing Authorization Application (MAA), and updates to IND and NDA documents; Provide expert clinical operations input into preparation for key regulatory meetings (e.g. End-of-Phase 2 and 3 Meetings, Request for Scientific Advice Meetings, etc.),  as appropriate

· Collaborates with and is responsible to the Senior Director, Clinical Operations to ensure adequate clinical operations resources are assigned to program

· Support functional strategic initiatives and processes managed by Clinical Development Services Group

· Act as a role model for Takeda´s values

· Line Manager for clinical operations staff

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

· Provides expert counsel for issue resolution, including projects assigned to other staff, when required

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


SUPERVISED                                                                         NUMBER OF EMPLOYEES


Employees 2-6 0-5

Non-Employees 1-4 10-15


(List the education and experience required to perform the primary responsibilities of the job.  Equivalent combinations of education and experience should be noted.)

Education:  Bachelor’s Degree or international equivalent required, Life Sciences preferred.  Advanced degree is highly desirable.


· 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

· Excellent teamwork, 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 

· Support a culture of continual improvement and innovation; promote knowledge sharing 

Experience: 12+ 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 is advantageous.  Demonstrated excellence in leadership and project/program management, including innovative operations approaches to achieving program goals.


(Modify text below as necessary)

· Requires approximately 10-20 % travel, including overnight and international travel to other Takeda sites, strategic partners, and therapeutic area required travel.


Boston, MA

Worker Type


Worker Sub-Type


Time Type

Full time

Job ID R0013015

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