Therapeutic Area Pharmacogenomics Liaison

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OBJECTIVES:

Responsible for interfacing with various Therapeutic area units to initiate, design and develop pharmacogenomics (PGx) programs. Responsible for review of synopses and Pharmacogenomics clinical trial design and results. Responsible for providing guidance to TA program leaders on the incorporation of Pharmacogenomics activities into various clinical programs. Provide leadership and oversight of Pharmacogenomics development activity.

ACCOUNTABILITIES:

- - Accountable to Head of Pharmacogenomics and Therapeutic Area Leads to provide strategic clinical input with emphasis on Pharmacogenomics.
- - Ensure Pharmacogenomics strategies and requirements and well articulated in designated clinical development programs and any programs that require PGx activities.
- - Primary interface with key stakeholders including commercial, regulatory, statistical science, clinical operation, project management , etc . to provide consultation in the area of PGx.
- - Providing Pharmacogenomics support and advice to sample population collection and management.
- - Accountable for managing a team of therapeutic area managers and cross functional groups
- - Member of the PGx leadership team.
- - Representing PGx at TA Unit as advisory member.
- - Providing clinical and strategic support to evaluation of external Pharmacogenomics opportunities.
- - Providing supports in interactions with FDA and key opinion leaders relevant to assigned TA or compounds.
- - Proactive identification of challenges and development of contingency plans as appropriate.
- - SYNOPSIS / PROTOCOL DEVELOPMENT, STUDY EXECUTION, & STUDY INTERPRETATION
- - - Consistent with membership of the TGRD Synopsis Review Committee, responsible for critical review of Synopses relating to studies in assigned compounds .
- - EXTERNAL INTERACTIONS
- - DUE DILIGENCE, BUSINESS DEVELOPMENT AND ALLIANCE PROJECTS
- - - Responsible for evaluation of potential business development opportunities related to PGx activities.
- - - Conducts due diligence evaluations, of clinical PGx development plans for potential alliances and or in-licensing opportunities.
- - - Serves as clinical contact point for ongoing alliance projects and interface with partner to achieve Takeda's PGx strategic goals while striving to maintain good working relationship between Takeda and partner.
- - - Assigns and manages Pharmacogenomics staff who are involved in many of these activities.
- - LEADERSHIP, TASK FORCE PARTICIPATION, UPPER MANAGEMENT ACCOUNTABILITY
- - - Interacts directly with research division based on pertinent clinical and development expertise and in all aspects relating to assigned compound in regional area . Leads TGRD internal teams and global cross-functional teams. Works with functional leadership to prioritize projects within the therapeutic area.
- - Hires, manages, mentors, motivates, empowers, develops and retains staff to support assigned activities. Conducts performance reviews and drive goal setting and development planning.