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 an Associate Director, Cell Product Clinical Translation in our Cambridge office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As an Associate Director working on the Cell Product Clinical Translation team, you will be empowered to provide strategic oversight of the Cell Therapy portfolio and recommend key selections and modifications to clinical trial design, and a typical day will include:
Takeda s Cell Product Clinical Translation team is uniquely positioned to integrate cell product and clinical CART biomarkers to investigate correlatives associated with cell product efficacy and safety in oncology indications. This position s primary role is to provide team leadership and scientific expertise in generating clinical and integrating cross-functional biomarker data from various line functions to investigate safety, efficacy and mechanisms of resistance and relapse in cell therapies. In this unique role you will be at the scientific forefront of cell therapies striving towards improving outcomes for patients with B cell malignancies and solid tumors.
- Prepares study protocols, reports, technology transfer documentation, and regulatory documents for clinical trials.
- Investigates 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.
- Provides strategic, technical and scientific leadership to cell therapy clinical project teams for integrated translational research strategy.
- Collaborates closely with other key line functions within the Oncology therapeutic area including discovery, DMPK and TREC
- Responsible for the development of project strategy and communicates complex data/decisions within department and cross functionally
- Presents study results at team or department meetings, to external partners or at conferences.
- Establishes project timelines and deliverables and plans/coordinates project work accordingly with departmental, functional and external stakeholders
- Commits resources to execute specific project tasks.
- Leads local and global initiatives or work streams
- Recognized as a subject matter expert in cell therapies or immuno-oncology
EDUCATION, EXPERIENCE AND SKILLS:
Education and Experience:
- Bachelors degree in chemistry, biology, pharmacy, or related pharmaceutical science and 15+ years relevant industry experience
- Masters degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 13+ years relevant industry experience
- PhD in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 10+ years relevant industry experience
- Experience in multidisciplinary clinical projects and teams with ability to integrate cross-functional information
- Experience in CART, immunology, immune-oncology, vaccines or virology with strong understanding of solid tumor or B cell malignancies
- 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
- Experience with immune-phenotyping by FACS (flow cytometry), primary cell culture, immunofluorescence, ELISA, and PCR
- 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
Knowledge and Skills:
- Analytical and Problem Solving Skills - Able to troubleshoot critical issues or problems using appropriate information and, determine causes and possible solutions
- Teamwork -- Ability to work well on global cross-functional teams.
- Communication Skills -Able to expresses one s self clearly and concisely within team; documents issues and/or concerns concisely with colleagues; adjusts communication style as appropriate for the audience; timely and effectively communicates with senior management; technical writing skills to support authorship and approval of internal technical documents
- Organization Exercises good time management and prioritization skills to balance multiple project and departmental objectives
- Technical - Subject matter expertise in a specific scientific area or areas. Demonstrated ability to successfully contribute across multiple scientific endeavors
- Knowledge Sharing - Ability to capture knowledge within the organization; improves solutions, processes, and deliverables through use of information; improves information capital by contributing experience, theories, deliverables, and models for others to use
- Resource Management -Project management skills; ability to manage one s time within individual, departmental, and corporate goals and timelines; management of internal external resources (vendors)
- External Involvement Demonstrated involvement in professional community evidenced by presentation of scientific posters or lectures at professional conferences or events. Interacts with external vendors for projects
- Leadership Skills Develops and uses knowledge and interpersonal skills to appropriately influence and guide others towards the accomplishment of department/function goals and objectives.
- May require approximately 10% 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.
No Phone Calls or Recruiters Please.