Senior Director, Clinical Operations - Oncology
Company: Takeda Pharmaceutical
Location: Boston
Posted on: January 27, 2023
Job Description:
By clicking the Apply button, I understand that my employment
application process with Takeda will commence and that the
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with Takeda's Privacy Notice and Terms of Use . I further attest
that all information I submit in my employment application is true
to the best of my knowledge. Job Description Are you looking for a
patient-focused, innovation-driven company that will inspire you
and empower you to shine?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 realize their potential through life-changing work.
Certified as a Global Top Employer, we offer stimulating careers,
encourage innovation, and strive for 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 a vital contributor to our inspiring, bold
mission.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.OBJECTIVES:
- Responsible for Oncology clinical operations strategy,
execution, and management of clinical programs in assigned
therapeutic area or disease Pathway or therapeutic area(s) or
disease pathway(s), supporting clinical strategy defined in the
Clinical Development Plan (CDP).
- Responsible for Oncology clinical operations financial
planning/forecasting and budget management for assigned therapeutic
area or therapeutic areas. Responsible for administrative budget
oversight for direct and indirect reports.
- Represents Oncology clinical operations as primary point of
contact for therapeutic area, internal stakeholders and Strategic
Partners and vendors.
- Responsible for leading the development of consistent Clinical
Operations processes and creating the support for unified
approaches across therapeutic areas.
- Initiates, develops, leads and/or participates in global
initiatives representing clinical operations in support of Takeda
R&D objectives.ACCOUNTABILITIES:
- Collaborates with Oncology global functional heads and TA
leadership to define operational strategy for clinical programs,
including risk management and contingency planning for clinical
programs and clinical studies. Responsible for on-time, on-budget
delivery of oncology clinical trials.
- Ensures Oncology clinical operations process and work product
is compliant with global regulatory and compliance requirements for
clinical research, including but not limited to US CFR, EU CTD,
local country requirements and ICH GCP.
- Direct management of clinical operations staff.
- Responsible for oversight of clinical budget
planning/forecasting and management for assigned therapeutic
area.
- Oversees, reviews and approves operational due diligence for
new compounds/alliances for budgeting, timelines, and enrollment
modelling.
- Maintains oncology therapeutic area knowledge and continually
assesses impact of new and evolving information on operational
strategies.
- Escalates issues related to quality, timelines and budget and
provides recommendations to upper management for resolution of
these issues.
- Supports strategic outsourcing by participating in strategic
vendor governance, including identification and resolution of
performance issues.
- Leads and/or participates in initiatives for process,
technology or other continuous improvement to achieve
cost-reduction, time-savings, efficiency, quality and/or other
business objectives.
- Responsible for functional leadership in oncology clinical
operations, including both direct line management (hiring,
training, staff assignments, coaching, mentoring, and performance
management) and indirect management of global clinical operations
staff in a Matrix environment.
- Acts as a role model for Takedas values.EDUCATION, BEHAVIOURAL
COMPETENCIES AND SKILLS:
- Bachelor's Degree or international equivalent required, Life
Sciences preferred. Advanced degree highly desirable.
- 15+ years' experience in pharmaceutical industry and/or
clinical research organization, including 10+ years clinical
study/program management, including at least 6 years of line
management experience. 5+ Years' experience in Early Oncology and a
proven track record of leadership and project management success at
the director level required.
- Expert knowledge of global regulatory and compliance
requirements for clinical research, including but not limited to US
CFR, EU CTD, local country requirements and ICH GCP.
- Global/International experience required, including ability to
manage intercultural regionally based teams and fluent business
English skills (oral and written).
- Experience in successful change management (strategy,
initiation, development and implementation of important,
organization wide changes).
- Previous line management or direct management of team
members.WHAT TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution
Plan
- Tuition reimbursement Company match of charitable
contributions
- Health & Wellness programs including onsite flu shots and
health screenings
- Generous time off for vacation and the option to purchase
additional vacation days
- Community Outreach ProgramsBase Salary Range: 194,000.00n to
278,000.00. 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.In accordance with the CO Equal Pay Act, Colorado
Applicants Are Not Permitted to Apply.Empowering Our People to
ShineDiscover more at No Phone Calls or Recruiters Please.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 Boston, MA Worker Type Employee Worker Sub-Type
Regular Time Type Full time
Keywords: Takeda Pharmaceutical, Boston , Senior Director, Clinical Operations - Oncology, Executive , Boston, Massachusetts
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