Director, Clinical Operations
Company: Takeda Pharmaceuticals
Location: Richmond
Posted on: January 27, 2023
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Job Description:
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that all information I submit in my employment application is true
to the best of my knowledge.Job DescriptionDirector, Clinical
OperationsAre you looking for a patient-focused company that will
inspire you and support your career? If so, be empowered to take
charge of your future at Takeda. Join us as a Director, Clinical
Operations based in our Cambridge/Lexington office or remotely.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 accomplish their potential
through life-changing work. Certified as a Global Top Employer, 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 deliver
Better Health and a Brighter Future to people around the
world.Here, you will be an important contributor to our inspiring,
bold mission.OBJECTIVES: 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 Operations
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 Takedas obligations described in ICH-GCP and
Takedas 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)). The
Director, Clinical Operations will also take on functional
leadership responsibilities including line management, providing
expert consult for issue resolution and assisting the Senior
Director, Clinical Operations.ACCOUNTABILITIES: 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 Program Team (GPT)
and/or 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
Takedas 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.EDUCATION,
EXPERIENCE,KNOWLEDGE AND SKILLS: Bachelors Degree or international
equivalent required, Life Sciences preferred. Advanced degree is
highly desirable. 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.
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.TRAVEL
REQUIREMENTS: Requires approximately 10-20 % travel, including
overnight and international travel to other Takeda sites, strategic
partners, and therapeutic area required travel.WHAT TAKEDA CAN
OFFER YOU:
Keywords: Takeda Pharmaceuticals, Richmond , Director, Clinical Operations, Executive , Richmond, Virginia
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