Associate Director, Program Strategy/ Safety Assessment, Preclinical & Translational Development (SGD)
Bluebird Bio, Cambridge, Massachusetts, United States
integrated product platforms with broad therapeutic potential
ABOUT THE NEST
At bluebird, only two things matter - patients and our people. When you join the nest, you're not just landing a new gig, you become a part of a flock that's soaring to new heights. We’re 1100+ doers, thinkers and collaborators across the globe with a strong sense of our values and our purpose. Our innovation and sustainability are rooted in the diversity of our teams and results are achieved through cooperation and the incorporation of multiple points of view. This is personal and we approach every challenge with radical care. The time is now to rise up and recode the science, the systems, and the status quo.
ABOUT THE FLOCK
The Preclinical & Translational Development group works with bluebird bio’s discovery platforms and translational research teams to generate the hypotheses, mechanism-of-action, and efficacy data that fuel the bluebird pipeline. We also work with our clinical and regulatory teams to generate the pharmacolgy, toxicology and biodistribution data that is critical to translating each of bluebird’s innovative therapies safely from research into patients. In doing so, we continuously strive towards our mission to be the biotech world’s best Preclinical & Translational Development organization for immunotherapy and gene therapy. Our valued associates experience room to grow their careers, a supportive, flexible and collaborative work environment, and respect for a diversity of experiences and perspectives.
HOW YOU’LL FLY
Responsible for nonclinical program strategies and the design, implementation and reporting of preclinical in vitro and in vivo pharmacology and/or toxicology (safety) studies to support bbb clinical development programs:
- Support nonclinical and translational development of severe genetic disease gene therapy programs from discovery to commercial phase, including collaborations
- Drive development study protocols, study results interpretation and report generation to support the preparation of integrated nonclinical summaries for early and late stage regulatory applications
- Collaborate with Preclinical and Translational Development and Research colleagues in the further development of clinical assets and IND candidates, as well as novel assays to support the pipeline
- Represent Preclinical & Translational Development at Program Teams and other meetings related to product progression from discovery to development to commercialization
- Work cross-functionally across the organization to ensure effective execution on nonclinical program deliverables, including with Research, CMC, Regulatory, and Clinical functions
- Assess products for mechanism(s) of toxicity to determine clinical relevance and ways to minimize clinical impact and/or effectively position bluebird products
- Support scientific strategy to guide the design of novel translational biomarker assays and lab-developed tests required for new programs, ensuring appropriate application in nonclinical studies
- Manage contract research laboratory (CRO) study director and business/scientific partner interactions as needed
- Represent bluebird bio and the Preclinical & Translational Development function at scientific meetings and in industry consortia; develop publishable nonclinical/toxicology research packages
WHAT YOU’LL BRING
You’re the bird we’re looking for if you have:
- Ph.D. in Molecular and/or Cellular Biology, Immunology, or related field, with 5-10 years of experience as a toxicologist/translational scientist within the pharmaceutical industry
- Experience in the nonclinical development of biotherapeutics, cell therapies and gene therapies is essential
- Strong background and/or demonstrated skills in the practical application of investigative safety
- General familiarity with drug development (Genetic Disease) and a strong foundation in rare disease research
- Candidates must be familiar with regulatory guidelines to support clinical development and registrational filings
- Must have strong MS Word and Excel and GraphPad Prism experience and strong report writing credentials
*will consider remote candidates*
All our birds embrace the principles of the bluebird bio culture: b colorful, b cooperative, b yourself.
bluebird bio is deeply committed to fostering an environment where diversity and inclusion are not only valued, but prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways. Diverse viewpoints bring diverse capabilities which strengthen our focus and fuel our growth.
bluebird is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.
About Bluebird Bio
About us We are leading the gene therapy revolution. Our integrated product platforms encompass gene therapy, cancer immunotherapy and gene editing – providing us with the potential to treat, and hopefully cure, a broad range of serious diseases. We have a lot of energy, and it’s not just the abundance of coffee that keeps us going. Find out what sparks our excitement and inspires us every day.
Want to learn more about Bluebird Bio? Visit Bluebird Bio's website.
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