Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Senior Scientist Immunology Nonclinical Safety Assessment in our Cambridge office.
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.
This position is for an individual with a strong immunology background who ideally also has experience in nonclinical safety assessments. The position is in the Drug Safety Research and Evaluation (DSRE) group at Takeda, located in Cambridge, MA. This person will serve as the DSRE project team member on multi-discipline research and development teams, being responsible for design, reporting, and interpretation of regulatory nonclinical safety studies. In addition, the individual will serve as an internal resource for safety assessments of immunology-related targets. This position will support programs across Takeda's 4 therapeutic areas: oncology, gastroenterology, neuroscience and rare diseases; and all the modalities used across those areas (e.g., small molecules, protein therapeutics, oligonucleotides, and cell and gene therapies). As a member of multi-disciplinary project teams, the individual will engage with other functional areas (e.g., Regulatory Affairs, Manufacturing, Pharmacovigilance, and Clinical Research) to develop project plans and go/no-go decisions, in part by providing guidance on the necessary types of nonclinical studies and the implications from safety study findings on project plans/decisions. The individual must be scientifically independent and able to articulate safety risks to a broad audience both internally and externally. The level of the position (Scientist to Scientific Director) will be commensurate with experience in immunology and nonclinical safety.
The primary duties of this position include the following:
Serve as the DSRE team representative on development programs in GI, neuroscience, oncology and rare diseases across a range of modality types
Recommend and advise on immunology-related safety assessments for regulatory studies
Serve as study director on internal exploratory studies, and scientifically oversee the design, reporting and interpretation of exploratory and GLP-compliant outsourced safety studies
Succinctly and effectively summarizes the content and safety implications from nonclinical studies for regulatory submissions, including components for IBs and clinical protocols
Interact with Health Authorities, in writing and verbally
Interacts with other functional area experts in a project team environment to recommend the best course of action for a given program, and defend those recommendations to internal governance committees
Represents Takeda in external venues, including scientific meetings and with potential partners
PhD in immunology or PhD in a related field with a strong background in immunology
Experience researching and understanding adverse effects of immunology-related pathways
Good collaboration and communication skills working in team environments and in matrixed-management settings
Previous pharmaceutical industry experience desired
Experience in design, reporting, and interpreting safety studies, and experience in the conduct GLP studies are pluses
Board certification is a plus (DABT or DAVBT)
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
No Phone Calls or Recruiters Please.
Takeda Pharmaceuticals North America