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The Associate Medical Director leads and drives strategy for
the overall regional (US/EU) clinical development taking into consideration the
medical, scientific, regulatory and commercial issues for assigned Takeda
pipeline compound(s). Leads a multi-disciplinary,
multi-regional, matrix team through highly complex decisions. This individual has the responsibility 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. Applies clinical/medical decision making to
clinical development issues. This individual
interacts with and influences TGRD and TPC senior leadership decision-making by
setting strategic direction. Success or
failure directly translates to the ability of TGRD to meet its corporate goals
and for Takeda to have future commercial products.
Development team participation and leadership
Clinical Science on US/EU Development Teams and will serve as leader of this
team. Supports the Global Development
Team (US, EU, Japan)
to ensure that the US/EU Development Team activities are aligned with the
global strategy. May act as Global
Development Team (US, EU, Japan) Leader managing
both the US/EU Development Team and the Japan Development Team for an early or
a smaller scope product.
for 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. Ongoing work output will involve 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. Recommends high impact global decisions.
Responsible for 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/or commercial viability of a product.
/ Protocol Development, Study Execution, & Study Interpretation
all 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 be 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.
data from an overall scientific standpoint as well as within the context of the
medical significance to individual patients.
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.
final decisions regarding study conduct related to scientific integrity.
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.
Leads incorporation of advice / recommendations received into the design
of clinical studies and programs as appropriate.
Diligence, Business Development and Alliance
for evaluation of potential business development opportunities and conduct of
due diligence evaluations assessing scientific, medical and development
feasibility, evaluating complete or ongoing clinical trials, and regulatory
interactions and future development plans.
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 in
conjunction with TPNA/TPEU/TPC. 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.
Task Force Participation, Upper Management Accountability
with research division based on pertinent clinical and development expertise
and with TPNA/TPEU to provide knowledge / understanding of market environment
in line with status as TGRD scientific content matter expert for assigned
compounds. Represents clinical science and
leads internal task forces and TGRD internal teams as well as global
cross-functional teams as appropriate.
manages, mentors, motivates, empowers, develops and retains staff to support
assigned activities. Conducts performance reviews and drive goal setting and
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- MD or internationally recognized equivalent plus
3 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 matrix
- Management experience preferred
- Superior communication, strategic, interpersonal
and negotiating skills
- Ability to proactively predict issues and solve
- Ability to drive decision-making within a
multi-disciplinary, multi-regional, matrix teams
- Diplomacy and positive influencing abilities
- Therapeutic area knowledge relevant to mechanism
- Regional/global Regulatory requirements
- Emerging research in designated therapeutic area
- Ability to drive to or fly to various meetings
or client sites, including overnight trips. Some international travel may be
- Requires approximately 10 - 20% travel.
WHAT TAKEDA CAN OFFER YOU:
401(k) with company match and Annual Retirement Contribution Plan
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 Programs
Learn more at takedajobs.com.
Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visit http://www.takeda.us/careers/EEO_Policy_Statement.aspx
No Phone Calls or Recruiters Please.