Description
Lead India R&D Strategy and Execution
- Work closely with OTAU GPTs a and Global R&D functions to optimize integrated India development strategy for pipeline assets
- Monitor overall country performance and support country focused oncology activities e.g. feasibility and site selections to deliver country operational milestones
- Serve as the internal expert on India’s clinical development to inform global development strategy. Collaborate closely with India LOC to execute One Oncology strategy in India including tapping into local expertise and community networks
- Collaborate and work closely with Oncology GPTs, the Global R&D team and regional teams, as appropriate, for each asset or indications under the remit
- Engage study investigators to maintain strong interest and focus on Takeda’s oncology clinical trials
- Proactively build and maintain strong investigator networks in India to support current and future trials across Takeda’s oncology portfolio in both solid tumors and hematologic malignancies and proactively share with the OTAU and Global teams
- Build and scale global clinical trial capabilities in India as a key market in collaboration with LOC, Region and Global teams to accelerate Takeda innovation and boost efficiency
Clinical Development team participation and leadership
Leads the Development Team in India for assigned compounds. In some cases may lead clinical directors or clinical scientist(s) responsible for leading this team with an emphasis on proactively identifying contingencies, risks, and mitigation strategies.Directs Development Team strategy and deliverables overseeing the Development Strategy, Clinical Development Plan and Clinical Protocols in India. Recommends scope, complexity and size, which influence the budget of all aspects of a program. Provides continual critical and constructive 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 India specific 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. Plans clinical development strategies in context of medical / clinical significance considering how a given product will fit in with current treatments, standard of care, and unmet medical need.C. Synopsis / Protocol Development, Study Execution, & Study Interpretation
Trial Medical Monitoring
External Interactions
Due Diligence, Business Development and Alliance Projects
Leadership, Task Force Participation, Upper Management Accountability
Lead India Oncology Clinical Science team
Serving as Country Matter Expert
Lead and develop oncology clinical strategies for India according to business needs as assignedEducation, Experience, Knowledge and Skills :
Skills
Knowledge
TRAVEL REQUIREMENTS :
Locations
Mumbai, India
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time