Director Clinical Operations Program Leader
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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.
· 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.
Job ID R0013015