Associate Director, Clinical Operations Program Lead
Company: Takeda Pharmaceuticals
Location: Little Rock
Posted on: May 27, 2023
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Job Description:
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Job Description
Are you looking for a patient-focused company to inspire you and
support your career? If so, be empowered to take charge of your
future at Takeda. Join us as an Associate Director Clinical
Operations Program Lead in our Cambridge/Lexington office or
remotely reporting to the Clinical Operations Leadership team.
Here, everyone matters and you will be an important 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:
GOALS:
Provide operational expertise and strategic input to the
development of Clinical Development Plans (CDP) supporting the
clinical strategy for one or more clinical programs, which may
include complex, high-risk, and high-priority programs.
Lead the program-level operational strategy and planning on
assigned programs in close collaboration with our strategic
partners and other vendors.
Provide program-level sponsor's operational oversight of our
strategic partners and other vendors to ensure the development of
the clinical studies on time, and within agreed budget.
Represent Clinical Operations at the Global Program Team (GPT) and
partner with Global Clinical Lead to lead the Clinical Sub Team
(CST) accountable for developing the CDP.
Take on functional leadership responsibilities, providing expert
consult for issue resolution and assisting the relevant
Director/Senior Director
Oversee strategic projects for process and business
improvements
ACCOUNTABILITIES:
Accountable to the GPT for translating the CDP into an operational
strategy and plan. Ensure assessment of several scenarios
operational for execution of the CDP.
Partner with the CST to develop high-quality study
synopsis/protocol by providing operational input and by ensuring
all relevant partners are involved and contributing.
Work with early or late phase COPL counterpart to ensure agreement
and seamless interactions with the GPT.
Communicate with the Global Program Leader to ensure expectations
and activities are aligned.
Lead the early or late phase clinical program operational strategy
and planning on assigned clinical programs in close collaboration
with the Clinical Operations Managers (COMs), our strategic
partners, other CROs, other vendors, and with the CST.
Perform program-level oversight of our strategic partners and other
vendors to ensure the operational execution and delivery of the
assigned clinical programs in compliance with quality standards
(including ICH GCP, local regulations and Takeda SOPs), and on
budget.
Work with COMs and counterparts to oversee the performance for all
activities assigned to our strategic partners/other CROs/other
vendors, including escalation of issues to governance committees
and to senior management when warranted.
Oversee clinical program budget planning and accountable for
external spend related to clinical program execution. Work with
COMs, Global Program Management (GPM), Outsourcing Management, and
Finance to ensure that budgets, enrolment, and gaiting are
accurate.
Communicate program status, cost and issues to senior
management.
Provide program-level direction and guidance to the COM in the
development of study strategy operational plans including enrolment
models and risk management strategy.
Be the point of escalation for the COMs for issues that can't be
resolved at the study level.
May participate in Business Development/in-licensing/alliances
evaluations by providing operational due diligence.
Review and provide expert clinical operations input into clinical
documents related to the drug development process including
Investigator Brochures, Investigational New Drug Applications
(INDs) and Investigational Medicinal Product Dossier (IMPDs), study
synopsis & protocols, clinical study reports, applicable sections
of the New Drug Application (NDA) and Marketing Authorization
Application (MAA), updates to IND and NDA documents, DSURs and
other safety reports; Provide expert clinical operations input into
preparation for essential regulatory meetings (e.g. End-of-Phase 2,
Request for Scientific Advice Meetings).
Work with COMs, Strategic Partners/other CROs/other vendors to
ensure inspection readiness.
Lead Clinical Operations aspects of inspection readiness activities
and act as an expert during regulatory inspections.
Lead strategic projects and process improvement.
Seek new ways of working to meet the needs of clinical
development.
Be a role model for Takeda -s values.
Recognized as a clinical operations expert by other departments and
team members across R&D.
Help with onboarding and mentoring of COMs and Senior Manager
COPLs.
May assist the Director/Senior Director in your function.
For certain types of studies and programs, COPL may have the
following responsibilities:
Is an essential contact between the strategic partners/preferred
supplies and the GPT/CST.
Provide program & study-level direction to the strategic
partners/preferred suppliers to develop study strategy operational
plans including enrolment models and risk management strategy.
Perform site feasibility/capability assessments for
programs/studies requiring specialized experimental tests and
technologies and work with internal experts and sites to ensure
successful operational outcomes.
Work with Procurement, QA & Legal to qualify new clinical vendors
and manage vendors for duration of a study (for vendors contracted
directly with Takeda).
EDUCATION AND EXPERIENCE:
Education:
Bachelor's degree (Life Sciences) or international equivalent
required. Advanced degree is desirable.
Skills:
Excellence in program management, including scenario assessment,
risk assessment and contingency planning.
Excellent matrix leadership.
Embody a culture of improvement and progress; promote knowledge
sharing.
Fluent business English.
Experience
10+ years' experience in pharmaceutical industry or clinical
research organization, including 7+ years clinical study/project
management.
Experience must include early phase clinical studies/Phase 2
studies or later phase global/international programs.
Experience in more than one therapeutic area.
Expertise in global regulatory and compliance requirements for
clinical research, including US CFR, EU CTD, and ICH GCP.
Awareness of local country requirements is also required.
TRAVEL REQUIREMENTS:
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WHAT TAKEDA CAN OFFER YOU:
Base Salary Range: $180,000 to $200,000. Employees may also be
eligible for Short Term and Long-Term Incentive benefits. Employees
are eligible to participate in Medical, Dental, Vision, Life
Insurance, 401(k), Charitable Contribution Match, Holidays,
Personal Days & Vacation, Tuition Reimbursement Program and Paid
Volunteer Time Off.
The final salary offered for this position may take into account a
number of factors including, but not limited to, location, skills,
education, and experience.
This posting is made in compliance with Colorado's Equal Pay for
Equal Work Act, C.R.S. - 8-5-101 et seq.
EEO Statement
Takeda 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.
Locations
Massachusetts - Virtual
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
#LI-Remote
Keywords: Takeda Pharmaceuticals, Little Rock , Associate Director, Clinical Operations Program Lead, Executive , Little Rock, Arkansas
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