The Sr. Clinical Scientist represents and may lead clinical science on the regional clinical development of assigned Takeda pipeline compounds. Leads a multi-disciplinary, , matrix work group ensuring that scientific issues are appropriately considered with respect to highly complex data findings. This individual has significant impact on the creation, maintenance, and execution of a clinical development plan in assigned area that will result in the regulatory approval of the compound in multiple regions.
Clinical Development team participation and leadership
- Represents Clinical Science on US/EU Development Teams and serve as leader of a working group. Supports the Global Development Team (US, EU,Japan) to ensure that the Development Team activities are aligned with the global strategy.
- Responsible for overseeing the production of deliverables required to support the Development Strategy, Clinical Development Plan and Clinical Protocols. Is responsible for the planning and completion of specific sections of the Development plan strategy.
- Recommends scope, complexity and size, and influence the budget of all aspects of a program.
- 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 them.
- Contributes to high impact global decisions: monitoring and interpreting data from ongoing internal and external studies 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.
Synopsis / Protocol Development, Study Execution, & Study Interpretation
- Assumes primary responsibility for the completion of protocol synopsis, obtaining scientific and corporate review committee approval including presentation and defense of the Synopses during review committee meetings, review and approval of documents related to study Protocols (e.g. Statistical Analysis Plans and Safety Management Plans). Provides scientific contributions and overall content approval of written responses required by IRB / Ethics Committees and critical study training meetings (e.g. Investigator Meetings). Responsible for review of study data, interpretation of results and communication of study conclusions within the company.
Trial Medical Monitoring
- Manages collection of necessary information to assess issues relating to protocol conduct and/or individual subject safety. Provides preliminary assessments to Medical Monitor for review and approval.
- Responsible for ensuring overall safety information is reviewed and analyzed in conjunction with Pharmacovigilance and Medical Monitor of record.
- Presents and interacts with regulatory authorities / agencies and key opinion leaders relevant to assigned compound and participate in meetings with representatives of the regulatory organizations and the identification / contact / maintenance of strong Company relationships with key opinion leaders. Influences establishment of strategy for the compound, and the development of documents required to outline the Company positions on research programs or regulatory applications (e.g. briefing reports), materials used for meeting presentations, and formal responses to communications received by the Company. Responsible for successful incorporation of advice / recommendations received from organizations or specialists into the design of clinical studies / programs as appropriate.
Leadership, Task Force Participation, Upper Management Accountability
- Interacts directly with research division based on pertinent clinical and development expertise and to provide knowledge / understanding of market environment in line with status as scientific content matter expert for assigned compounds. Represent clinical science on internal task forces. Leads internal teams as appropriate.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Bachelor s degree and 12 years of clinical research and/or clinical development experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of afore mentioned.)
- Master s degree and 10 years of clinical research and/or clinical development experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of afore mentioned.)
- PharmD and 9 years of clinical research and/or clinical development experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of afore mentioned.)
- PhD and 7 years of clinical research and/or clinical development experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of afore mentioned.)
- Superior communication, strategic, interpersonal and negotiating skills
- Ability to proactively predict issues and solve problems
- Ability to drive decision-making within a multi-disciplinary, multi-regional, matrix team
- Diplomacy and positive influencing abilities
- Therapeutic area knowledge relevant to mechanism of action
- Regional/global Regulatory requirements
- Emerging research in designated therapeutic area
- Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required.
- Requires approximately 10-20 % travel.
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