Clinical Scientist, TAK-007 (CD19-CAR-NK), Oncology Clinical Science応募後で応募 求人ID R0024023 掲載日 04/23/2021 Location:Boston, Massachusetts
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine?
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Here, you will be a vital contributor to our inspiring, bold mission.
- The Clinical Scientist, Oncology Clinical Science for project TAK-007 (CD19-CAR-NK) provides the strategic leadership and scientific direction to ensure that clinical development programs are appropriately designed to support strategy and objectives of the program.
- This individual interacts with Study Execution Team (SET) and Clinical Subteam (CST) by suggesting strategic direction and providing expert therapeutic area and clinical development input.
- This clinical scientist will work closely with the program medical directors in development of key study documents and performing data review to support team meeting its corporate goals.
Clinical Development team participation and leadership
- Participates SET/CST and ensures alignment with the global Asset Strategy.
- Executes the Asset Strategy producing the Clinical Development Plan and Clinical Protocols. Recommends scope, complexity, and size of a program which impacts budget decisions.
- Provides scientific expertise to functional area representatives in SET/CST on disease state, study design, and scientific rationale in clinical studies for cell therapy portfolio
- Provides on-going 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, proactively identifying challenges, and developing contingency plans to meet them.
- Recommends high impact decisions. Responsible for monitoring and interpreting data from ongoing internal and external studies. Assesses the scientific implications and makes 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, budget or product labeling.
- Ensures quality of Regulatory Affairs clinical submissions, manages Clinical Development issues, and helps to develop interface between R&D and other functional areas.
- Generates and reviews clinical regulatory documents in area of scope: Investigational New Drug (IND) Applications, Briefing Documents, Investigational Brochures (IB), IND annual reports, Investigational Medicinal Product Dossiers (IMPD), common technical documents as the basis for new drug applications (NDA) and Marketing Authorization Applications (MAA), other regulatory documents and scientific white papers.
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 Data Monitoring
- Integrates necessary information to assess issues relating to protocol conduct and/or individual subject safety. Provides preliminary assessments to Medical Monitor for review and approval.
- Has significant input on the final decisions regarding study conduct related to scientific integrity.
- Reviews and assesses overall safety information in conjunction with Pharmacovigilance and Medical Monitor of record.
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
- Bachelor’s, Master’s, PharmD, or PhD degree and 5-10 years of clinical research and/or clinical development experience within the pharmaceutical industry, CRO health-related consulting company, or academia
- Direct experience with executing development plans with oncology products, preferably cell therapies
- Knowledge in the principles of the scientific method, cancer biology and immunology.
- Expert knowledge in the overall pharmaceutical drug development process, experience in lymphoma and/or leukemia will be preferred.
- Expert knowledge of global regulatory and compliance requirements for clinical research, including but not limited to US CFR and ICH GCP
- Strong written and verbal Communication Skills: ability to express oneself clearly and concisely to external partners or within the team.
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
Discover more at takedajobs.com
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This job posting excludes CO applicants