Head, Translational Biomarkers, Preclinical and Translational Development

Company: bluebird bio
Location: Cambridge
Posted on: April 8, 2021

Job Description:

Head, Translational Biomarkers, Preclinical and Translational Development On January 11, 2021, we announced our intent to separate our severe genetic disease and oncology businesses into differentiated and independent publicly traded companies. We will retain focus on severe genetic disease (SGD) and will launch our oncology business ("Oncology Newco") as a new entity, with the completed transition expected by the end of 2021. 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 Preclinical and Translational Development (PTD) flock is looking to hire an experienced, Director level leader to head the Translational Biomarker group in our new Oncology Company. The candidate will be leading the bioanalytical lab and clinical lab operations that work on oncology programs from preclinical development through IND and beyond. The Translational biomarker group works very closely with other groups within PTD, Research, CMC and clinical development organization, all working towards the overall mission of providing transformative therapies to our cancer patients. This role requires the writing and reviewing of preclinical and clinical biomarker sections in regulatory documents, including INDs, MAAs, and BLAs. Success in the role will depend on collaboration across Research, Regulatory, QA, Vendor Management, Research, IT, CMC, and external vendors to develop and implement processes and standards and to develop regulatory filings. Alignment of the conduct and reporting of bioanalytical testing with Good Clinical Practice (GCP) as well as FDA, EMA, ICH and all other applicable regulatory requirements is also a critical function of the role. --HOW YOU'LL FLY The Preclinical and Translational Development (PTD) team works with bluebird bio's Research (Oncology), Clinical, CMC and Regulatory teams to develop robust target liability assessment, pharmacology and toxicology (in vitro and in vivo), and translational biomarker data that allows accelerated transition from the bench to the clinic, from discovery through IND, late-stage clinical development and licensure. In doing so, we continuously strive towards our mission to bring curative therapies to our patients. As an/a Translational Biomarker bird reporting to the Head of PTD,--you'll help to bring more patients their bluebird days by:

• Design, drive, and execute on biomarker strategies in partnership with Oncology research and clinical development teams with a special focus on forward and reverse translation for T-cell therapies
• Manage a group of assay development scientists whose primary role is to independently develop, validate, and execute on bioanalytical assays to support predictive, PK/PD, and immunogenicity endpoints in preclinical and clinical development
• Support cross functional teams with analysis of biomarker data and contribute to internal and external scientific correlative analysis discussions
• Direct or indirect experience with assays such as multiplex flo, MSD, ELISA, qPCR, IL-2 independent growth assay, single cell western, VCN etc.
• Provide scientific guidance on the assay type to be deployed, frequency of testing, sample matrix, clinical protocol language, and laboratory manuals
• Experience working with CRO partners with a special emphasis on qualification of vendors, technology transfer of in-house assays, vendor management from quality, capability, data flow, interpretation, and reporting perspectives for clinical trial samples
• Experience in clinical sample management and critical reagent oversight
• Build a team that represents translational biomarker at nonclinical and clinical subteam meetings
• Review study data on an on-going basis and prepare data presentations for updates to cross-functional teams
• Review and approve bioanalytical protocols, reports, and related documentation
• Author and review study reports, biomarker sections of clinical protocols, and documentation required for regulatory submissions including INDs, BLAs, and MAAs WHAT YOU'LL BRING You're the bird we're looking for if you:
  • Strong scientific background in a relevant field (Biology, Biochemistry, Immunology, other), PhD 5+ years of relevant experience or MSc with 10+ years of relevant experience within the biopharmaceutical industry.
  • Experience across all phases of drug development; specific experience in cell therapy preferred
  • Extensive knowledge of assay development, qualification, and validation of bioanalytical and biomarker assays under FDA, EMA, ICH GCP/GLP and other applicable guidelines
  • Experience in development of clinical bioassays, e.g. biomarkers, PD, PK, ADA and CDx
  • Experience in authoring and critically reviewing technical documents, study protocols and reports related to assay development, validation, and clinical sample testing
  • Experience writing and reviewing biomarker sections of study reports and regulatory documents (IND, BLA, MAA)
  • Manage a small group of assay development scientists and clinical lab operation specialists
  • Demonstrated ability to manage multiple complex projects and programs simultaneously
  • Excellent attention to details, critical thinking, and data interpretation
  • Strong communication (oral and written) and interpersonal skills
  • Excellent organizational, multi-tasking and collaboration abilities 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. Will you now or in the future require bluebird bio to commence ("sponsor") an immigration case in order to employ you (for example, H-1B or other employment-based immigration case)? --*
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Keywords: bluebird bio, Cambridge , Head, Translational Biomarkers, Preclinical and Translational Development, Other , Cambridge, Massachusetts