Clinical Scientist/ Sr. Clinical Scientist - United States
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Senior Clinical Scientist working on the GI Clinical Science team, you will be empowered to work with cross-functional, matrix teams and contribute to high impact global decisions, and a typical day will include:
- The Clinical Scientist represents and may lead clinical science on the regional (US) clinical development of assigned Takeda pipeline compounds
- Leads a multi-disciplinary, matrix team ensuring that scientific issues are appropriately considered with respect to highly complex data findings
- 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
- 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 deliverables producing the Development Strategy, with significant contributions to assign sections of the Clinical Development Plan and Clinical Protocols.
- Participates in recommending 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 for those areas assigned.
- 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) for assigned sections
- 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 for assigned sections
- 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.
- External Interactions
- 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 to provide knowledge / understanding of market environment in line with status as Development scientific content matter expert for assigned compounds
- May represent clinical science on internal task forces
- May lead internal teams as appropriate
EDUCATION, EXPERIENCE, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Bachelor’s degree 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)
- Master’s degree 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)
- PharmD degree and 6 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
- Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required.
- Requires approximately 10-20 % travel.
WHAT TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution Plan
- Tuition reimbursement
- Company match of charitable contributions
- Health & Wellness programs including onsite flu shots and health screenings
- Generous time off for vacation and the option to purchase additional vacation days
- Community Outreach Programs
Empowering Our People to Shine
Learn more at takedajobs.com.
Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visit http://www.takeda.us/careers/EEO_Policy_Statement.aspx
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