Director, Translational Biomarkers

ABOUT THE FLOCK

The Translational Biomarkers Director/ Associate Director works with bluebird bio’s discovery platforms and 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 pharmacology, toxicology and bioanalytical data that is critical to translating each of bluebird’s innovative therapies safely from research into patients. You will be joining and collaborating with an awesome and extremely talented flock of birds who are passionate about science and keep patients at the forefront of everything they do. We have delivered two gene therapy approvals in one year, and are on our way to a third submission to FDA. Come work with a hard-working and fun group of birds that loves rising to the challenge!

In this role, you will work across multiple gene and cell therapy program teams to help develop, plan, and execute biomarker strategy for programs from preclinical to late-stage clinical trials and post-marketing registration studies. You will lead project-specific activities to establish quantitative and pharmacodynamically relevant bioanalytical strategies to support preclinical and clinical drug candidates. 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 will also be a critical function of the role.

HOW YOU’LL FLY

You’ll help to bring more patients their bluebird days by:

• Developing and driving biomarker execution strategies in collaboration with research and clinical study teams
• Overseeing early and late-stage clinical studies supporting cell and gene therapy platforms; helping to translate scientific discoveries into clinical biomarker strategies, enabling pharmacodynamic biomarker assessment and providing insight into combination strategies
• Supporting cross functional teams with analysis of biomarker data and contribute to internal and external scientific correlative analysis discussions
• Authoring and reviewing study reports, biomarker sections of clinical protocols, and documentation required for regulatory submissions including INDs, BLAs, and MAAs
• Representing Translational Biomarkers in program teams, translational sub-teams, and clinical trial sub-team meetings
• Overseeing assay performance and data interpretation for existing programs to ensure quality throughout Research, Development and Clinical phases of product development
• Collaborating with biomarker clinical assay development team to design biomarker strategies and interpret biomarker assay data (e.g. biomarkers, CTA/CDx, anti-drug antibody assays, PK/PD). Review and approve bioanalytical protocols, reports, and related documentation
• Reviewing study data on an on-going basis and prepare data presentations for updates to cross-functional teams

WHAT YOU’LL BRING

You’re the bird we’re looking for if you have:

• Strong scientific background in a relevant field (Biology, Biochemistry, Immunology, other), PhD 5+ years of relevant experience or BS/MSc with 10+ years of relevant experience within the biopharmaceutical industry.
• Experience across all phases of drug development; specific experience in gene therapy or stem 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)
• Ability to working in a fast-paced, dynamic environment and demonstrated ability to manage multiple complex projects and programs simultaneously
• Excellent attention to details, critical thinking and data interpretation.