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 Associate Scientific Director in our Cambridge office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Associate Scientific Director working on the Discovery Toxicology team, you will be empowered to focus on therapeutic drug development through toxicology studies and design and coordinates mechanistic and toxicology studies, and a typical day will include:
Join our growing pharmaceutical drug development team to advance novel therapeutics.
The candidate will serve as representative of Drug Safety Research Evaluation (DSRE) on drug development teams for immunomodulatory drug candidates evaluating and preparing regulatory submissions, providing a safety perspective to project teams and DSRE management on scientific and regulatory toxicology issues likely to impact the drug development process. The candidate will also be actively engaged in influencing the external environment through presentations, publications, and leadership roles in external scientific organizations.
We are seeking an individual with immunology expertise and experience in toxicology to evaluate potential immune system-related risks associated with our biologics, cell and gene therapy pipeline. This individual will provide strategic and scientific input to multidisciplinary Project Teams with the key goal of progressing novel biologic, cell and gene therapies from discovery to the clinic and beyond. The successful candidate will be a project toxicologist, who will make significant contributions to the safety strategy for biologic, cell and gene therapy products within a diverse R&D organization.
- With a focus on therapeutic drug development through toxicology studies, this role requires a deep appreciation for immunology
- Provides scientific contributions which have significant impact on portfolio progress or development of technical capabilities, based on benchmarking to industry best-in-class
- Collaborate, support and lead non-clinical development teams in the design and analysis of non-clinical safety studies for biologic, cell and gene therapy programs which includes risk mitigation strategies; regulatory suitability; issue resolution and decision analysis
- Leads the preparation of key documentation needed across all nonclinical safety aspects (e.g. Investigator s brochure, IND/IMPD, CTD etc.)
- Responsible for the scientific and toxicologic evaluation of selected drug candidates. Designs and coordinates mechanistic and toxicology studies to support project and discovery working groups;
- Integrates available mechanistic, biochemical, toxicological, immunological, clinical, statistical, toxicokinetic, and pathologic data into study reports for regulatory submissions;
- Assures compliance with GLP and SOPs, safety and animal welfare guidelines.
- Maintain an industry leading expertise in Immunology as it relates to the safety of biologics, cell and gene therapeutics including representation on industry consortia or working groups
- Support and lead where necessary the in/out-licensing opportunities through due diligence activities
- PhD degree in a scientific discipline with 10+ years of experience, or MS with 14+ years of experience, or BS with 16+ years of experience with immunology, immunotoxicology or related expertise as applied to drug development
- The ability to manage multiple therapeutic programs in parallel and prioritize while delivering on key milestones. Experience with development of biologics, cell and gene therapies is preferred
- The ability to communicate data and results both internally and externally and to manage collaborations with academia and industry partners
- Demonstrated experience working to global Regulatory guidelines ideally directly working with Health Authorities
- PhD in Toxicology, Pharmacology, Immunology or a related Bioscience subject; MD, DVM with relevant work experience would also be suitable
- Strong oral and written communication skills, as well as a collaborative spirit are critical
- Outstanding expertise and depth of knowledge within a scientific area
- Keeps up with the up-to-date scientific advancement (e.g. competitive landscape, new technology, new research portfolio, and new partnership)
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.