Director, Clinical Operations
Company: Takeda Pharmaceuticals
Posted on: September 25, 2022
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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.Here, everyone matters and you will be a vital contributor
to our inspiring, bold mission. As an Associate Director Clinical
Operations Program Lead working on the Clinical Operations team,
you will be empowered to lead study operational strategy and
planning and oversee execution of clinical studies for an assigned
clinical program(s), supporting clinical strategy defined in
Clinical Development Plan, and a typical day will
include: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
- Lead and manage multiple clinical programs within the TA
through the direct supervision of additional Clinical Operations
- 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
- 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
- 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
- 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
- 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
- Experience must include early phase experience or Phase 2 and 3
studies and global/international programs.
- Experience in more than one therapeutic area is
- Demonstrated excellence in leadership and project/program
management, including innovative operations approaches to achieving
- 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
- Supervisory experience.
- Demonstrated excellence in project/program management and
- Excellent teamwork, organizational, interpersonal, and
- 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:
- 401(k) with company match and Annual Retirement Contribution
- Tuition reimbursement
- Company match of charitable contributions
- Health & Wellness programs including onsite flu shots and
- Generous time off for vacation and the option to purchase
additional vacation days
- Community Outreach ProgramsLocation and Salary Information:
- Location(s): Cambridge, MA, Lexington, MA or remote.
- Base Salary Range: $160,000 - $229,000 based on candidate
professional experience level.Empowering Our People to ShineLearn
more at takedajobs.com .No Phone Calls or Recruiters Please.EEO
StatementTakeda 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.LocationsMassachusetts - VirtualWorker TypeEmployeeWorker
Sub-TypeRegularTime TypeFull time#LI-Remote
Keywords: Takeda Pharmaceuticals, Harrisburg , Director, Clinical Operations, Healthcare , Harrisburg, Pennsylvania
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