Senior Director / Head of Translational Medicine and Biomarker Strategy

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Senior Director / Head of Translational Medicine and Biomarker Strategy

The Head of Translational Medicine reports to the Chief Medical Officer and is accountable for timely and effective biomarker development and support for AVROBIO’s ex vivo lentiviral-based gene therapy programs. This translational medicine leader is expected to develop and implement the gene therapy biomarker strategy across AVROBIO’s clinical-stage portfolio. The candidate will have a deep understanding of disease biology and relevant biomarkers and experience in designing and executing on clinical translational biomarker plans. The successful candidate will contribute to the development of our overall translational medicine strategy, manage external contractual relationships, and will lead the scientific and operational discovery, development, validation and progression of relevant tissue and fluid biomarkers for AVROBIO’s gene therapy programs.

Remote
Medical
May 23 2022
Key Responsibilities
  • Collaborates with clinical development, centralized analytical development, and partner-line colleagues to develop and execute clinical biomarker strategies that include the transition of selected biomarkers from proof-of-concept to later stage trials that will support submission, label or/and influencing medical communities
  • Identifies, evaluates, and prioritizes candidate-predictive biomarkers and enable the development of potential clinical companion diagnostic tests that will appropriately transition from early to late phase clinical development
  • Works directly with clinical, regulatory and program team leads to refine clinical translational research efforts
  • Works closely with contract research organizations (CROs) and other external parties by serving as primary point of contact and providing scientific expertise for outsourced clinical development projects
  • Serves as a member of the clinical development team and translation medicine teams to interpret biomarker results in the context of the clinical study
  • Scientifically evaluates complex data able to appropriately guide study teams through complex issues resolution relating to biomarker design and outcomes
  • Establish credible visibility with key stakeholders and the scientific community through external and internal presentations and peer-reviewed publications
  • Maintains up-to-date knowledge of disease area clinical research, global regulatory guidances & expectations, and industry best practices
  • Selects, establishes, and manages external collaborations with contract and research organizations and other vendors to identify, develop and validate diagnostic, prognostic, pharmacodynamic and other biomarkers to support our pipeline in lysosomal storage disorder gene therapies.
Minimum Requirements/ Qualifications
  • PhD in biology, molecular biology, immunology, pharmacology or related field and research background in a relevant disease area with 10+ years of experience
  • Demonstrated current understanding of disease biology, genetics, and relevant immunology in one or more therapeutic areas with a preference for rare disease and/or metabolic disease or lysosomal storage diseases
  • Working knowledge of biomarker measurement methods such as NGS, IHC, qPCR, FISH, FACS, and other technologies and related data analysis tools. Gene therapy-specific assay experience including Vector Copy Number, Insertion Site Analysis, etc. would be highly preferred.
  • Prior experience leading small translational medicine teams in a way that inspires and generates high quality outcomes
  • Effective managerial skills and leadership of diverse teams of scientists with complementary skills
  • Experience in “leading from the bench” at times when necessary to accomplish translational medicine goals on time and to a high scientific standard
  • Budget planning and oversight experience in both external (CRO) partnerships and internal operational expense tracking
  • Demonstrated ability or potential to design, initiate, and conduct clinical studies focusing on integrating and executing biomarker plans that support clinical development objectives
  • Experience in clinical protocol design, late-stage clinical development, clinical trial operations, clinical validation of biomarker assays, and interaction with clinical development leaders
  • Direct experience interacting with regulatory authorities and supporting regulatory submissions & regulatory queries, and inspections
  • Ability to think strategically, work effectively and execute multiple projects simultaneously.
  • Highly effective communication skills: verbal, written, and presentation. Demonstrates ability to present clinical data, study plans and strategy to relevant audiences to inform and direct decisions
  • Experience in providing vendor oversight for biomarker development and validation
  • Firsthand experience in the development and validation of biomarker assays and proven assay troubleshooting skills in the preclinical and clinical setting
  • Strong collaborative leadership style, stakeholder management, and evidence of strategic scientific thinking
  • Demonstrated experience in risk assessment and mitigation frameworks for biomarker-driven clinical trials
  • Demonstrated track record in scientific leadership and contributions to multiple research projects, including strong publication/presentation record
  • Solid working knowledge about good laboratory (GLP) and good clinical practices (GCP) as well as CLIA regulations

 

About AVROBIO

Our vision is to bring personalized gene therapy to the world. We aim to prevent, halt and/or reverse disease throughout the body with a single dose of gene therapy designed to drive durable expression of therapeutic protein, even in hard-to-reach tissues and organs including brain, muscle and bone. AVROBIO’s pipeline is powered by our industry-leading plato® gene therapy platform, our foundation designed to deliver gene therapy worldwide. It includes clinical programs in cystinosis and Gaucher disease type 1, as well as preclinical programs in Gaucher disease type 3, Hunter syndrome and Pompe disease. We are headquartered in Cambridge, Mass.

AVROBIO, Inc is an EEO employer.