Medical Director, Clinical Science, Neuroscience TAU - Neurology/Neurosurgery
Location: Cambridge
Posted on: June 23, 2025
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Job Description:
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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 a Medical Director, Clinical
Science, Neuroscience- Neurology/Neurosurgery 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:
The Medical Director leads and drives strategy for the overall
global (US/EU/Japan/China) clinical development taking into
consideration the medical, scientific, regulatory and commercial
issues for assigned Takeda pipeline compounds. Leads a
multi-disciplinary, multi-regional, matrix team through highly
complex decisions. This individual has the ultimate responsibility
for development decisions assessing and integrating the input from
various disciplines to create, maintain, and execute a global
clinical development plan that will result in the regulatory
approval of the assigned compound in multiple regions. Applies
clinical/medical decision making to clinical development issues.
This individual interacts with and influences R&D and Global
Product Launch & Strategy (GPLS) senior leadership decision-making
for the projects by setting strategic direction. 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 Global (US/EU/Japan/China) Development Team for a
given product. May lead the Development Sub Teams or study teams
and represents Clinical Science on the Global (US/EU/Japan)
Development Team to ensure that activities are aligned with the
global strategy. Establishes and drives Development Team strategy
and deliverables producing the Development Strategy, Clinical
Development Plan and Clinical Protocols. Recommends scope,
complexity and size, and influence the budget of all aspects of a
program. Provides continual 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. Responsible for high impact global
decisions: monitoring and interpreting data from ongoing internal
and external studies, assessing the medical and scientific
implications, and making 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 or product labeling. A significant error in
judgment may result in loss of approvability and commercial
viability of a product. Synopsis / Protocol Development, Study
Execution, & Study Interpretation Drives clinical science
activities relating to the preparation / approval of synopses,
protocols and the conduct of clinical studies. Serves as an 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
determine how individual study results impact the overall compound
strategy. Interprets data from an overall scientific standpoint as
well as within the context of the medical significance to
individual patients. Trial Medical Monitoring Responsible for
medical monitoring activities, assessing issues related to protocol
conduct and/or individual subject safety. Assesses overall safety
information for studies and compound in conjunction with
Pharmacovigilance. Oversees non-medical clinical scientists with
respect to assessment of these issues. Makes final decisions
regarding study conduct related to scientific integrity. External
Interactions Directs activities involved in interactions with
regulatory authorities / agencies and clinical development
activities undertaken to establish and maintain strong
relationships with key opinion leaders relevant to assigned
compounds and therapeutic areas. These responsibilities include
leadership roles in meetings with the regulatory organizations or
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. Lead roles will also be taken on
the incorporation of advice / recommendations received into the
design of clinical studies / programs as appropriate; accountable
to senior leadership for the successful completion of related
objectives. Due Diligence, Business Development and Alliance
Projects Responsible for identification and evaluation of potential
business development opportunities, conduct due diligence
evaluations, and development and negotiation of clinical
development plans for potential alliances and or in-licensing
opportunities. Assesses scientific, medical, and development
feasibility, evaluating strategic fit with overall portfolio,
evaluating complete or ongoing clinical trials, assessing
regulatory interactions and future development plans, interacting
with upper management of potential partner/acquisition companies
during DD visits and alliance negotiations, and representing
clinical science on internal assessment teams in conjunction with
GPLS & Business Units. Serves as clinical contact point for ongoing
alliance projects and 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 directly
with Neuroscience Drug Discovery Unit based on pertinent clinical
and development expertise and with Business Units to provide
knowledge / understanding of market environment in line with status
as R&D scientific content matter expert for assigned compounds.
May represent clinical science on multidisciplinary task forces
across divisions (e.g. R&D USBU; GPLS, JPBU). Lead R&D
internal teams and may lead global cross-functional teams, as
appropriate. EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS: MD or
internationally recognized equivalent plus 7 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).
Specialized in Neurology or Neurosurgery Previous experience
successfully leading a clinical development team/matrix team with
responsibility for phase 3 clinical studies in multiple regions.
NDA/MAA/Submission experience preferred. Management experience
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 knowledge
Expertise in acute stroke or stroke recovery 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.
Empowering Our People to Shine Discover more at takedajobs.com No
Phone Calls or Recruiters Please. LI-JV2 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: Cambridge, MA
U.S. Base Salary Range: $228,200.00 - $358,600.00 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 Cambridge, 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: , Marthas Vineyard , Medical Director, Clinical Science, Neuroscience TAU - Neurology/Neurosurgery, Science, Research & Development , Cambridge, Massachusetts