Takeda Pharmaceutical Company Limited is a global, research and development-driven organization working internally and with external partners to translate science into life-changing medicines. Takeda focuses on the core therapeutic areas of oncology, gastroenterology, neuroscience and providing vaccines that address the most important infectious diseases. Novel products, especially in oncology and gastroenterology, as well as our presence in emerging markets, fuel our growth.
Our US Offices are in Cambridge, MA. Research & Development employees in our Cambridge location focus on oncology, gastroenterology, immunomodulation, biologics, translational research, and external innovation. In March 2016, we opened our newest space at 300 Massachusetts Avenue, featuring 230,000 square feet of state-of-the-art office and lab space.
While Takeda is enjoying tremendous growth as an emerging global leader in the pharmaceutical industry, we remain ever mindful of our commitment to serve people worldwide by striving toward better health through leading innovation in medicine. In short, we are a passionate team doing important work that impacts patients lives. If you are driven to create better health and a brighter future, join us!
The Clinical Scientist represents and will lead clinical science and global development of Takeda pipeline compounds. The candidate will be a key player of a multi-disciplinary, matrix team ensuring that scientific issues are appropriately considered with respect to highly complex clinical data findings. This individual has the responsibility for influencing the creation, maintenance, and execution of a clinical development plan that will have an impact on global strategies and may result in the regulatory approval of the compounds 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 local Development Team activities are aligned with the global strategy.
- 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.
- Contributes to major regulatory interactions and filing activities
- 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.
- Participates in recommending scope, complexity and size, and influence the budget of all aspects of a program.
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.
- 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, KNOWLEDGE 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
- Medical monitoring and trial excecution
- 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
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.
No Phone Calls or Recruiters Please.