Responsible for ensuring ongoing review and agreement of the Therapy Area Strategy and associated documents formulated by the TA leader prior to their review and approval by appropriate governance committees. Oversees the development and execution of the Integrated Development Strategy (IDS) and overall Integrated Global Development Plan (IGDP). Responsible for review of synopses and Critical Study Flash Results. Provide leadership and oversight of respective region development activity. Responsible for providing guidance to TA leaders on regional specificities within Therapeutic Area.
Accountable to Therapeutic Area Head and Regional Clinical Science Head to provide strategic clinical input with emphasis on regional input.
Accountable for ensuring regional strategies and trade-offs in regional requirements are well articulated in the global strategy documentation and that stakeholders are appropriately briefed.
TA advisor supports the Development TA leader on all global objectives and ensures that the regional view is represented in the global strategy by:
Synopsis / Protocol Development, Study Execution, & Study Interpretation
- Providing regional clinical leadership and oversight within TA
Managing GDT leaders within respective region(also, may serve as GDT leader as needed)
- Integrating and consolidating regional input from all relevant parties into the global view on TA development issues
- Providing strategic input into global development strategies and plans for all compounds in respective TA. Regional aspects are of particular focus
- Member of the PDD TA Leadership Team (TALT)
- Representing PDD at TA Unit as advisory member or as delegate for the PDD TA Head as requested by the TA Head
- Providing clinical and strategic support to evaluation of external compounds (alliances and in-licensing opportunities)
- Primary interface with regional Medical Affairs for regional strategy and in support of product commercial efforts
- Contributing to the creation and maintenance of regional KOL network
- Providing recommendations for GDT leader nominations and reviewers of external compounds to TA Head
- Liaison with Clinical Operations and Project Management for co-ordination of logistics study planing and implementation
- May line manage other clinical science staff within TA aligned teams in region
- Consistent with membership of the TGRD Synopsis Review Committee, responsible for critical review of Synopses relating to studies in assigned compounds. .
Trial Medical Monitoring
- Reviews and assesses overall safety information in conjunction with Pharmacovigilance and Medical Monitor of record for assigned compounds.
- Oversees and leads all clinical science activities involved in interactions with FDA and key opinion leaders relevant to assigned compounds.
- Responsible for evaluation of external interactions in the context of overall development strategies using complex problem solving in the region but in context of a global environment.
- Proactive identification of challenges and development of contingency plans as appropriate.
Due Diligence, Business Development and Alliance Projects
- Responsible for evaluation of potential business development opportunities in the region but with the context of a global environment.
- Conducts due diligence evaluations, of clinical 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 strategic goals while striving to maintain good working relationship between Takeda and partner.
- Assigns and manages clinical science staff who are involved in many of these activities.
Leadership, Task Force Participation, Upper Management Accountability
Qualifications EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
- 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.
- MD strongly preferred or internationally recognized equivalent with minimum 10 years pharmaceutical research experience, including minimum 7 years phases I-IV experience.
- Management experience in a matrix environnent.
- Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
- Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required.
- Requires approximately 25 % travel.
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