Under the direction of the therapeutic area VP, Clinical Science:
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 GDT/RDT Leader.
- 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 development process.
- 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 area.
- 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 organizational impact.
- 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 development opportunities.
- Manages Program Scientists, Senior Program Scientists, Associate Directors, Associate Medical Directors, Directors, or Medical Directors.
EDUCATION, 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 mentioned).
- Management experience required.
- 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 required.
we are driven to improve people's lives
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, visithttp://www.takeda.us/careers/EEO_Policy_Statement.aspx
No Phone Calls or Recruiters Please.