|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 Executive Medical Director in our Cambridge office.|
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As an Executive Medical Director working on the Clinical Science team, you will be empowered to develop clinical strategies and lead global clinical oncology programs, and a typical day will include:
- This position is responsible for
the clinical science leadership and oversight, especially from a portfolio
perspective, as well as strategic input to the development strategies and
development plans of all compounds in a therapeutic area in the Takeda Development
Portfolio, with am emphasis on regional perspective.
- This position has the
responsibility for the scientific design, data interpretation and
reporting of Phase I-IV clinical trials for the assigned compounds,
especially from a regional perspective, and is expected to influence and
challenge the strategy and decisions for the development programs within
the therapeutic area.
- Acts as the development and
scientific expert to internal and external audiences, including
evaluations of external compounds and opportunities.
- Under the direction of the
therapeutic area VP, Clinical Science.
- Cross Functional Impact (Effect on
scope of other functional areas): Directly if GDT/RDT Leader or indirectly
through Clinical Science staff. Initial work output (Development Strategy,
Development Plan and Clinical Protocols) dictates scope, complexity, size
and budget of all aspects of a program, especially from a regional
perspective. Ongoing work output (e.g., critical evaluation of program
progress and adjusting accordingly) changes program scope. A significant
error in judgment may result in loss of approvability of product.
- As appropriate, leads Global
Cross-Functional Development Program i.e., RDT (US, EU), or GDT (US, EU,
Japan): Oversees GDT/RDT team deliverables and strategy. May also be
- Feasibility Assessment: Lead the
creation of the product development clinical plan, including the design of
all the clinical studies. Establishes, through the development plan, the
conditions essential for determining the safety, efficacy, medical
usefulness, and marketability of candidate compound. Participate in
recruiting and communicating with opinion leaders during the plan
- Project Progress: Anticipates or
identifies project needs and maintains a state-of-the-art development plan
that is competitive and consistent with the latest regulatory
requirements, especially from a regional perspective.
- High Impact Global Decisions:
Monitors and interprets data from ongoing internal and external studies
and makes decisions that impacts development such as "go/no go"
decisions or modification of development plan or study design that may
have a significant impact on timeline or product labeling.
- Works closely and communicates
frequently with Clinical Operations and Project Management.
- Competitive and Scientific
information: TGRD Scientific Content Matter Expert on all scientific and
clinical aspects on therapeutic area to both internal and external
audiences. Establishes and maintains strong relationships with global and
regional key opinion leaders in assigned therapy areas, to optimize the
development of Takeda compounds and promote the company's reputation and
expertise in the designated area.
- Protocols, Reports and Regulatory
Submissions: Oversees regional scientific content and strategy and
influences the overall scientific content and strategy for therapeutic
- Leads negotiations with local
regulatory authorities impacting the review and approval process.
- Represents Clinical Science in
cross-functional teams or committees that have therapeutic area or
- Interacts with marketing companies
leading the therapeutic area perspective.
- Contributes to life cycle planning
for therapeutic area.
- Leverages regional vs global
studies to establish development synergies.
- Leads the clinical development
perspective in due diligence evaluation of external compounds and other
- Manages Program Scientists, Senior
Program Scientists, Associate Directors, Associate Medical Directors,
Directors, or Medical Directors.
EDUCATION, EXPERIENCE, BEHAVIOURAL COMPETENCIES AND SKILLS:
- MD or internationally recognized
equivalent with minimum 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
- Management experience required.
- Phase I - Phase IV/ Biomedical
pharmaceutical development clinical research experience preferred.
- Access to transportation to attend
various meetings held in proximity to the Takeda offices.
- Able to fly to various meetings at
investigator, vendor or regulatory agency sites.
- Some international travel will be
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.