Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Senior Scientific Manager, Cell Product Clinical Translation in our Cambridge office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Senior Scientific Manager in the Cell Product Clinical Translation Team, you will be empowered to build our Cell Therapy footprint, and execute our strategy.
The Senior Scientific Manager of Cell Product Clinical Translation will execute strategic plans for the build out of a world-class cell therapy group. The position will coordinate with other departments and manage daily operations in support of company goals and driving objectives to completion.
The position will work with research to support pre-clinical translational activities will also interact with external collaborators and internal research teams examining clinical sample biomarkers and outcomes and correlating therapeutic product critical quality attributes.
- Provides strategic, technical and scientific leadership to cell therapy clinical project teams for integrated translational research strategy across multiple programs.
- Collaborates closely with other key line functions within the Oncology therapeutic area including clinical, discovery, DMPK, analytical development and pre-clinical translational leads.
- Prepares study protocols, reports, technology transfer documentation, and regulatory documents for clinical trials.
- Coordinates efforts to investigate mode of action (MoA), critical quality attributes (CQA) and mechanisms of resistance and relapse in cell therapies through collaboration and integration of biomarker data from process development, manufacturing (CMC), product characterization, animal models, tumor microenvironment, clinical biomarkers, pharmacology, safety and efficacy.
- Responsible for the development of project strategy and communicates complex data/decisions within department and cross functionally
- Establishes project timelines and deliverables and plans/coordinates project work accordingly with departmental, functional and external stakeholders
- Recognized as a subject matter expert in cell therapies or immuno-oncology
- Commits resources to execute specific project tasks.
- Responsible for managing expenses within budget
EDUCATION, EXPERIENCE, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Advanced degree (MS or PhD) in relevant scientific discipline (such as Biotechnology, Immunology, Molecular Biology, Biochemistry), and prior experience
- Minimum 5 years of relevant experience in leadership and people management with successful performance track record. Experience in technical development of biologics and other advanced modalities in early and late development setting is highly desirable.
- Experience in multidisciplinary clinical projects and teams with ability to integrate cross-functional information
- In-depth knowledge of various mechanisms of therapeutic response and resistance mechanisms utilizing in vitro, in vivo or ex vivo patient-derived models
- Understanding of current therapeutic and combination therapy landscape, including immune-checkpoint blockade, in cancer immunotherapy (IO)
- Understanding of various cell and gene therapies, gene editing technologies with previous experience in CAR T cells, large molecules, vaccines or viral vectors
- Understanding of cell product immunogenicity, potency and cellular immunology with analytical development experience
- Experience in clinical trials, balanced experimental design, data visualization and basic statistical analysis are desirable
- A track record of independent critical thinking and scientific achievement demonstrated by national presentations and publications
- Prior experience with translational aspects of IND, NDA or BLA desirable
- Occasional travel is required.
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.
No Phone Calls or Recruiters Please.