US-MA, Director Clinical Operations Program Leader R0013015-MZ
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
SCOPE OF SUPERVISION:
SUPERVISED NUMBER OF EMPLOYEES
NUMBER SUPERVISED WORKERS Direct In-Direct
Employees 2-6 0-5
Non-Employees 1-4 10-15
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
(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.
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.
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