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Job Description

Objective / Purpose:

This is a key position in GI2 TAU clinical science to accelerate the drug development in India, and belongs to organization of RnD China & APAC. This role is the local clinical lead to drive the drug development from clinical development strategy establishment to local registration in India as member of China Asia Development Team, with close collaboration with cross function team members of CADT, India Development Lead, India business operation and other relevant global and local stakeholders. 

In some cases, the scope may be extended to other Asia countries/regions besides India based on the business needs.

• Leads and drives local strategy and clinical development plan taking into consideration the medical, scientific, regulatory and commercial issues for the assigned Takeda pipeline compound(s) in GI2.
• Interacts with and influences Takeda’s senior leadership decision-making by setting strategic direction locally.
• Cultivates and manage relationships with local KOLs and investigators.
• Play a crucial role as the local clinical lead for the assigned studies, including the development of study concept, synopsis, protocol, booster enrollment engagement activities, study conduction, databased lock, data interpretation, and etc.
• Applies clinical expertise as the local clinical lead for the CTA, NDA, and the interaction with local Health Authorities.

Accountabilities:

Clinical Development team participation and leadership

• Leads and drives local clinical development strategy and deliverables for GI2 pipeline assets, including the Development Strategy, Clinical Development Plan and Clinical Protocols. 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 regulatory submission and approval goals locally.
• Leads or supports high impact decisions based on strong clinical/scientific expertise as well as leadership: monitors and interprets data from ongoing internal and external studies, assessing the medical and scientific implications, and making recommendations that impact local 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. 

Synopsis / Protocol Development, Study Execution & Study Interpretation

• Drives clinical science activities relating to the preparation / approval of synopsis, protocols and the conduct of clinical studies. Accountable for the successful design and interpretation of clinical studies.  Presents study conclusions to Management and determine how individual study results impact the overall compound strategy.
• Interprets data from an overall scientific standpoint as well as within the context of the medical significance to individual patients.

Booster enrollment activities and Trial Medical Monitoring

• Provides strong supports to the local booster enrollment activities from clinical perspective
• Responsible for medical monitoring activities, assessing issues related to protocol conduct and/or individual subject safety. 
• Assesses safety information for studies and compound in conjunction with Pharmacovigilance.

External Interactions

• Directs activities involved in interactions with local regulatory authorities / agencies and clinical development activities undertaken to establish and maintain strong relationships with local key opinion leaders. 
• Leads collaboration with academia, local development network to advance drug development in India. Lead roles will also be taken on the incorporation of advice / recommendations received into the design of clinical studies/programs as appropriate, and ensuring these activities are aligned with the RnD China&APAC region and global strategy.

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Due Diligence, Business Development and Alliance Projects

• May participate in 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 complete or ongoing clinical trials, assessing local regulatory interactions and future development plans, and representing clinical science on internal assessment teams in conjunction with other parts of the organization.  

Leadership, Influence, Leading Capability Development, Communication and Collaboration Capability Development,and Multidisciplinary Task Force

• Demonstrates strong leadership and clinical/scientific expertise to influent key internal stakeholders from RnD China & APAC and global about pipeline/compound strategy and decision making.
• Proactively leads TA capability development by coaching and mentoring to local team members; advocates and creates share-learning and growth supportive environment.
• Proactively leads and contributes in multidisciplinary task forces on across divisions representing clinical science to increase local team/organization capability and efficiency.
• Embraces innovation, diversity and inclusive culture in teams/organization and leading as a local role model, brandings RnD China&APAC on behalf of GI2 Clinical Science team.     
• Keep strong communication and collaboration capability with the team members to ensure high quality and timely deliverables. 

Education & Competencies:

• MD or internationally recognized equivalent plus minimum 15 years of clinical practice and/or research experience.
• Direct experience in GI2 therapy pharmaceutical development, or related field required
• Previous experience of influencing senior-level management and key stakeholders is a plus
• Previous experience successfully leading a clinical development team/matrix team with responsibility for studies in India. The experience in other Asia countries/regions is a plus.
• Fluent in English and Indian. 
• NDA/MAA/Submission experience preferred
• Management experience
• Excellent communication and collaboration skills
• Models the Takeda Leadership Behaviors                                                                                                                                                                   

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