Join our generation.

Associate Director / Director, Translational Research

Cambridge, Massachusetts, United States

Generation Bio is a biotechnology company leading a new generation of gene therapy. With our proprietary re-dosable ceDNA technology, we are expanding the reach of gene therapy. At Generation Bio, our goal is to bring the life-saving benefits of gene therapy to more people, living with a broader range of diseases, in more places around the world. Our vision is to make the ravages of genetic disease as imaginary to the next generation as polio feels to children today.

We are a thriving, collaborative, creative community of diverse talents, beliefs, and experiences relentlessly dedicated to our mission. Founded and launched by Atlas Venture. Headquartered in Cambridge, Massachusetts. Committed to a future where more people can live full lives.

Delve further. Please visit www.generationbio.com or follow @generationbio.

SUMMARY

Generation Bio seeks an energetic and highly motivated team member to lead initiatives to inform and to execute on our translational research strategy. This role will leverage data to design and develop translational biomarker strategies including digital health strategies in order to monitor the activity, safety and efficacy of our novel gene therapy platform in the clinic. This role is very cross-functional with key interactions across regulatory, clinical, R&D, and others. This role will impact the development of multiple novel research programs.

RESPONSIBILITIES:

  • Design and develop new methods to investigate activity, safety and efficacy of our novel gene therapy platform in the clinic (i.e. home monitoring of blood Phe levels; digital/wearable strategy for examining cognitive function)
  • Develop translational biomarker strategies to support multiple clinical stage programs by incorporating the latest research findings and cutting-edge technologies
  • Explore and implement new biomarkers of clinical relevance (pharmacodynamic, predictive, prognostic and safety)
  • Interrogate clinical natural history databases to assess endpoints, variability, patient heterogeneity, genotype/phenotype relationships and to inform patient stratification
  • Lead the development, outsourcing and validation of clinically relevant biomarker assays (e.g., pharmacodynamic, predictive, prognostic and safety biomarkers)
  • Support global regulatory strategy and contribute to the generation of investigator brochures, IND applications, clinical protocols and other regulatory documents as appropriate
  • Effectively interface with other research groups to facilitate the success of projects in a highly matrixed environment
  • Engage with advocacy groups and regulators in defining unmet need and ways to assess this in the clinic
  • Compile and present research data to cross-functional teams
  • Write protocols to perform exploratory assays on clinical samples

QUALIFICATIONS:

  • MD or PhD with more than 6 years of biotech or pharma experience supporting clinical trials (Phase I/II)
  • Scientific training and hands on experience with pharmacology
  • Experience developing and supporting translational biomarker strategies for novel therapeutics
  • A strong grounding in statistical analysis methods and/or prior experience with analysis of large biological datasets
  • Rare disease and/or pediatric experience is a plus
  • Experience leading and working on multiple projects simultaneously. Attention to detail and ability to organize and prioritize tasks in a timely and accurate manner to meet tight deadlines
  • Advanced problem-solving and interpersonal skills
  • Exceptional written and verbal communication
  • Evidence of scientific accomplishments in the form of publications and/or presentations
  • Excellent computer skills and database analytics capabilities and experience with Microsoft Excel, Flow cytometry data analysis software, and Graphpad Prism or equivalent

POSITION: Full-Time, Exempt

EEOC Statement: Generation Bio believes in a diverse environment and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Generation Bio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

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