The Principal Scientist in Clinical Science represents and may lead clinical science on the regional (US) clinical development of assigned Takeda pipeline compounds. Leads a multi-disciplinary, multi-regional, matrix team ensuring that scientific issues are appropriately considered with respect to highly complex decisions. This individual has the responsibility for influencing the creation, maintenance, and execution of a clinical development plan 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 may serve as leader of this team. Supports the Global Development Team (US, EU, Japan) to ensure that the US/EU Development Team activities are aligned with the global strategy.
Responsible for development team strategy and deliverables producing the Development Strategy, Clinical Development Plan and Clinical Protocols. 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.
Reviews and assesses overall safety information in conjunction with Pharmacovigilance and Medical Monitor of record.
Successfully contributes to interactions 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 with TPNA/TPEU to provide knowledge / understanding of market environment in line with status as TGRD scientific content matter expert for assigned compounds. May represent clinical science on internal task forces. May lead TGRD internal teams as appropriate. Qualifications
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
Bachelor’s degree and 15 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.)
PhD and 5 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
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 10-20 % travel.
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Takeda Pharmaceuticals - 2 years ago