Senior Manager, Clinical Operations Program Lead
Company: Takeda Pharmaceuticals International GmbH
Posted on: April 5, 2021
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important to us. Due to the current situation related to the
Coronavirus (COVID-19), we're leveraging our digital capabilities
to ensure we can continue to recruit top talent at Takeda. As your
application progresses, you may be asked to use one of our digital
tools to help you through your recruitment journey. If so, one of
our colleagues will explain how these tools will be used during the
recruitment process. Thank you. *Please be aware of an Identity
Theft Scheme targeting individuals seeking jobs with Takeda and
other employers. See below or here for more info. Senior Manager,
Clinical Operations Program Lead Takeda fosters a collaborative and
stimulating work environment filled with opportunity and the chance
to make a difference in people's lives. It is a workplace driven by
integrity, one of Takeda's long-held values that extends to both
the patients we serve and our employees who develop and deliver
medicines. Across our company, Takeda employees bring together
diverse strengths that together create a stronger whole. As one of
the world's leading biopharmaceutical companies, Takeda is
committed to bringing Better Health and a Brighter future to people
worldwide. We aspire to bring our leadership in translating science
into life-changing medicines to the next level, in our core focus
areas; oncology, gastroenterology, neuroscience, rare diseases,
plasma-derived therapies, and vaccines. The Greater Boston Area is
headquarters to many of our Global and US business units. We are a
passionate team doing important work that impacts patients' lives.
If you are driven to create better health and a brighter future,
join us! Success What makes a successful member of our team? Check
out the traits we're looking for and see if you have the right mix.
Life at Takeda A Global Top Employer Recognized for our culture and
way of working, we're one of only select companies to receive Top
Global Employer -- status for 2021. Senior Manager, Clinical
Operations Program Lead Job ID R0025960 Date posted 01/07/2021
Location Boston, Massachusetts Are 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 an Senior Manager, Clinical Operations Program
Lead in our Cambridge/Lexington office. 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
- Provide operational expertise and strategic input to the
development of Clinical Development Plans (CDP) supporting the
overall clinical strategy for one or more clinical programs.
- Develop and 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 effective
execution of the clinical studies on time, with high quality 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 the development and execution of the CDP.--
- Accountable to the GPT for the translation of the CDP into an
optimal operational strategy and plan. Ensures assessment of
various operational scenarios for optimal execution of the
- Partners with the CST to develop high quality study
synopsis/protocol by providing operational input and by ensuring
all relevant stakeholders (both internal and external) are involved
- Collaborate with early or late phase COPL counterpart to ensure
alignment and seamless interactions with the GPT.
- Maintain close communication with the Global Program Leader to
ensure expectations and activities are aligned.
- Develop and 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
- Perform program-level oversight of our strategic partners and
other vendors to ensure the overall operational execution and
delivery of the assigned clinical programs in compliance with
quality standards (including ICH GCP, local regulations and Takeda
SOPs), on schedule and on budget.
- Collaborate with COMs and cross-functional 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
- Responsible for clinical program budget planning and
accountable for external spend related to clinical program
execution.--Works closely with COMs, Global Program Management
(GPM), Outsourcing Management, and Finance to ensure on a regular
basis that budgets, enrolment, and gaiting are accurate.
- Communicates program status, cost and issues to ensure timely
decision-making by senior management.
- Provide program-level direction, guidance and support to the
COM in development of study strategy operational plans including
enrolment models and risk management strategy.
- Serve as 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/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), updates to IND
and NDA documents, DSURs and other safety reports; Provide expert
clinical operations input into preparation for key regulatory
meetings (e.g. End-of-Phase 2, Request for Scientific Advice
Meetings, etc.), as appropriate.
- Collaborate with COMs, Strategic Partners/other CROs/other
vendors to ensure inspection readiness.
- Leads Clinical Operations aspects of inspection readiness
activities, and acts as subject matter expert during regulatory
- Contribute to functional strategic initiatives and process
- Actively seek new ways of working more efficiently to meet the
needs of clinical development.
- Act as a role model for Takeda--s values.
- For certain types of studies and programs, COPL may have the
- Is a key point of contact between the strategic
partners/preferred supplies and the GPT/CST.
- Provide program & study-level direction and support to the
strategic partners/preferred suppliers for the development of study
strategy operational plans including enrolment models and risk
- Performs site feasibility/capability assessments for
programs/studies requiring specialized experimental tests and/or
technologies and work with internal experts and sites to ensure
successful operational outcomes--
- Work with Procurement, QA & Legal to qualify new clinical
vendors and, when appropriate, manage vendors for duration of a
study (for vendors contracted directly with Takeda) EDUCATION,
EXPERIENCE, AND SKILLS:
- Bachelor's Degree or international equivalent required, Life
Sciences preferred.-- 8+ years' experience in pharmaceutical
industry and/or clinical research organization, including 5+ years
clinical study/project management. Experience must include early
phase clinical studies/Phase 2 studies or later phase
global/international studies or programs. Experience in more than
one therapeutic area is highly desired. 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.
- Demonstrated excellence in project/program management,
including scenario assessment, risk assessment and contingency
- Demonstrated excellent matrix leadership and communication
- Able to influence without authority.
- Excellent teamwork, communication, 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.
- Embody a culture of continual improvement and innovation;
promote knowledge sharing.
- Fluent business English (oral and written). TRAVEL
- Requires approximately 5-20 % 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
- Health & Wellness programs including onsite flu shots and
- Generous time off for vacation and the option to purchase
additional vacation days. Check out where you could be
working if you apply. Job Seekers: Protect yourself against
identity theft Please be aware there are instances of identity
thieves posting Takeda-branded jobs and posing as employees to
steal personal information. They visit job-related websites and
invite candidates to online chats. During the chat, they press job
seekers to provide bank account information and Social Security
numbers. Copyright 1995-2019 Takeda Pharmaceutical Company Limited.
All rights reserved.
Keywords: Takeda Pharmaceuticals International GmbH, Cambridge , Senior Manager, Clinical Operations Program Lead, Executive , Cambridge, Massachusetts
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