|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 a Medical Director - Oncology Clinical Development in our Cambridge office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Medical Director working on the Oncology Therapeutic Area team, you will be empowered to work with cross functional teams and implement the clinical strategy, and a typical day will include:
Medical Director leads and drives strategy for the overall global (US/EU/Japan)
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 TGRD and TPC senior leadership decision-making
for the projects 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.
- Clinical Development
team participation and leadership
- Leads Global
(US/EU/Japan) Development Team managing both the US/EU Development Team and the
Japan Development Team for a given product. May lead the US/EU Development
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
- Interprets data from an
overall scientific standpoint as well as within the context of the medical
significance to individual patients.
- Trial Medical
- 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
- 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
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. May represent clinical
science on multidisciplinary task forces across divisions (e.g. TGRD and
TPNA/TPEU/TPC). Lead TGRD internal
teams and may lead global cross-functional teams, as appropriate.
- Hires, manages, mentors,
motivates, empowers, develops and retains staff to support assigned activities.
Conducts performance reviews and drive goal setting and development planning.
EDUCATION, EXPERIENCE, BEHAVIOURAL COMPETENCIES AND SKILLS:
or internationally recognized equivalent plus 5 years of clinical research
experience within the pharmaceutical industry, CRO health-related consulting
company, or biomedical/clinical experience within academia (or a combination of
experience successfully leading a clinical development team/matrix team with
responsibility for studies in multiple regions.
communication, strategic, interpersonal and negotiating skills
to proactively predict issues and solve problems
to drive decision-making within a multi-disciplinary, multi-regional, matrix
and positive influencing abilities
area knowledge relevant to mechanism of action
- Regional/global Regulatory requirements
research in designated therapeutic area
to drive to or fly to various meetings or client sites, including overnight
trips. Some international travel may be required.
approximately 15 - 25% 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
Empowering Our People to Shine
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.