Associate Director, Clinical Science, GI2 TAU
Company: Takeda
Location: Boston
Posted on: July 12, 2025
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Job Description:
By clicking the “Apply” button, I understand that my employment
application process with Takeda will commence and that the
information I provide in my application will be processed in line
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? Join us as an Associate Director,
Clinical Science, GI2 TAU in our Cambridge, MA 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 mission. POSITION OBJECTIVES:
Provides strategic leadership and scientific direction for the
clinical development for assigned Takeda pipeline compound(s).
Directs a multi-disciplinary, multi-regional, matrix team through
highly complex decisions. Responsible for development decisions
assessing and integrating the input from various disciplines to
create, maintain, and execute a clinical development plan that will
result in the regulatory approval of the compound in multiple
regions. Interacts with and influences GCDT leadership
decision-making by suggesting strategic direction and providing
expert therapeutic area and clinical development input Provides
clinical expertise and interacts with regulatory agencies such as
the FDA and EMEA. Success or failure directly translates to the
ability of R&D to meet its corporate goals and for Takeda to
have future commercial products. POSITION ACCOUNTABILITIES:
Clinical Development team participation and leadership Leads
Development Working Groups and ensures alignment with the global
strategy. May act as Global Development Team Leader managing both
the Takeda developed or licensed compounds. Executes and implements
the regional team strategy producing the Clinical Development Plan
and Clinical Protocols. Recommends scope, complexity, and size of a
program which impacts multimillion dollar budget decisions.
Provides scientific expertise to functional area representatives
GCDT on disease state, study design, and scientific rationale in
clinical studies for compounds within therapeutic area Provides
on-going critical evaluation of the development strategy to
maintain a state-of-the-art development plan that is competitive
and consistent with the latest regulatory requirements, proactive
identification of challenges, and development of contingency plans
to meet them. Recommends high impact regional decisions.Responsible
for monitoring and interpreting data from ongoing internal and
external studies.Assesses the scientific implications and makes
recommendations that impact regional and global development such as
“go/no go” decisions or modification of development plans or study
designs that may have a significant impact on timelines, budget or
product labeling. Ensures quality of Regulatory Affairs clinical
submissions, manages Clinical Development issues, and helps to
develop interface between R&D and other functional areas. A
significant error in judgment may result in loss of approvability
and/or commercial viability of a product. Authors/supports
publication and presentation of clinical and nonclinical data in
support of Takeda developed or licensed compounds. Generates and
reviews clinical regulatory documents: Investigational New Drug
(IND) Applications, Briefing Documents, Investigational Brochures,
Investigational Product Labeling, IND annual reports,
Investigational Medicinal Product Dossiers (IMPD), common technical
documents as the basis for new drug applications (NDA) and
Marketing Authorization Applications, other EMEA/CHMP regulatory
documents and scientific white papers. Synopsis / Protocol
Development, Study Execution, & Study Interpretation Leads several
Clinical Science activities relating to the preparation / approval
of Synopses, Protocols and the conduct of clinical studies. Serves
as a scientific advisor to other clinical scientists involved in
these activities, and is accountable for the successful design and
interpretation of clinical studies.Presents study conclusions to
Management and determines how individual study results impact the
overall compound strategy. Interprets data from an overall
scientific standpoint Trial Medical Monitoring Integrates necessary
information to assess issues relating to protocol conduct and/or
individual subject safety.Provides preliminary assessments to
Medical Monitor for review and approval. Has significant input on
the final decisions regarding study conduct related to scientific
integrity. Reviews and assesses overall safety information in
conjunction with Pharmacovigilance and Medical Monitor of record.
External Interactions Establishes, maintains and directs
interactions with key opinion leaders relevant to assigned
compounds and therapeutic area.Provides leadership in meetings and
negotiations with key opinion leaders, establishment of strategy
for assigned compounds, and the direction of clinical scientists
involved in developing documents required to outline the Company
positions on research programs or regulatory applications (e.g.
briefing reports), materials used for meeting presentations, and
formal responses to communications received from the regulatory
organizations or opinion leaders. May represents GCDT in written,
oral and face to face interactions with FDA and EU regulatory
agencies, providing clinical expertise within therapeutic area
Leads incorporation of advice / recommendations received into the
design of clinical studies and programs as appropriate.
Collaboratively interacts with scientists from alliance partners.
Due Diligence, Business Development and Alliance Projects
Responsible for evaluation of potential business development
opportunities and conduct of due diligence evaluations assessing
both scientific and development feasibility, evaluating complete or
ongoing clinical trials, and regulatory interactions and future
development plans. Contributes to the development and negotiation
of clinical development plans for potential alliances and or
in-licensing opportunities, interacts with upper management of
potential partner/acquisition companies during DD visits and
alliance negotiations and represents clinical science on internal
assessment teams. For ongoing alliance projects, will interface
with partner to achieve Takeda’s strategic goals while striving to
maintain good working relationship between Takeda and partner.
Leadership, Task Force Participation, Upper Management
Accountability Interacts with research division based on pertinent
clinical and development expertise to provide knowledge /
understanding of market environment in line with status as TGRD
scientific content matter expert for assigned compounds. Active
member of various Takeda committees and task forces which define
the processes for developing and implementing Global Takeda
standards that are used in clinical development, post-marketing
surveillance, and Pharmacovigilance process in order to promote the
consistency of data throughout the Takeda group companies.
Represents clinical science and leads internal task forces as well
as global cross-functional teams as appropriate. EDUCATION,
BEHAVIORAL COMPETENCIES AND SKILLS: Bachelors required with 15
years of clinical research experience within the pharmaceutical
industry, CRO health-related consulting company, or
biomedical/clinical experience within academia (or a combination of
afore mentioned) and professional license Masters in Sciences
preferred with 13 years of clinical research experience within the
pharmaceutical industry, CRO health-related consulting company, or
biomedical/clinical experience within academia (or a combination of
afore mentioned). PharmD preferred with 12 years of clinical
research experience within the pharmaceutical industry, CRO
health-related consulting company, or biomedical/clinical
experience within academia (or a combination of afore mentioned).
PhD in a related scientific discipline preferred with 10 years of
clinical research experience within the pharmaceutical industry,
CRO health-related consulting company, or biomedical/clinical
experience within academia (or a combination of afore mentioned).
Previous experience successfully leading a clinical development
team with responsibility for multiple studies. Global experience
preferred. NDA/MAA/Submission experience preferred Skills Superior
communication, strategic, interpersonal and negotiating skills
Ability to proactively predict issues and solve problems Ability to
drive decision-making within a multi-disciplinary, multi-regional,
matrix teams Diplomacy and positive influencing abilities Knowledge
Therapeutic area expertise knowledge relevant to disease states and
mechanism of action. Regional/global Regulatory requirements
GCP/ICH Emerging research in designated therapeutic area This
position is currently classified as “hybrid” in accordance with
Takeda’s Hybrid and Remote Work policy.” Takeda Compensation and
Benefits Summary We understand compensation is an important factor
as you consider the next step in your career. We are committed to
equitable pay for all employees, and we strive to be more
transparent with our pay practices. For Location: Boston, MA U.S.
Base Salary Range: $153,600.00 - $241,340.00 The estimated salary
range reflects an anticipated range for this position. The actual
base salary offered may depend on a variety of factors, including
the qualifications of the individual applicant for the position,
years of relevant experience, specific and unique skills, level of
education attained, certifications or other professional licenses
held, and the location in which the applicant lives and/or from
which they will be performing the job.The actual base salary
offered will be in accordance with state or local minimum wage
requirements for the job location. U.S. based employees may be
eligible for short-term and/or long-termincentives. U.S.based
employees may be eligible to participate in medical, dental, vision
insurance, a 401(k) plan and company match, short-term and
long-term disability coverage, basic life insurance, a tuition
reimbursement program, paid volunteer time off, company holidays,
and well-being benefits, among others. U.S.based employees are also
eligible to receive, per calendar year, up to 80 hours of sick
time, and new hires are eligible to accrue up to 120 hours of paid
vacation. 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 Job Exempt Yes
It is unlawful in Massachusetts to require or administer a lie
detector test as a condition of employment or continued employment.
An employer who violates this law shall be subject to criminal
penalties and civil liability.
Keywords: Takeda, Medford , Associate Director, Clinical Science, GI2 TAU, Science, Research & Development , Boston, Massachusetts
