Director, Translational Biology & Biomarkers

Sail Biomedicines•Cambridge, MA

About The Position

Sail Biomedicines is pioneering the integrative design and deployment of fully programmable medicines to transform patient care. Sail’s platform combines first-in-class programmable circular RNA technology (Endless RNA™ or eRNA), and an industry-leading platform of programmable nanoparticles, utilizing natural components, to unlock comprehensive programming of medicines for the first time. By leveraging cutting-edge eRNA and nanoparticle deployment technology, Sail is also making unparalleled use of AI techniques to identify and design fully programmable medicines that are potent, targeted, versatile, and tunable. Sail was founded by Flagship Pioneering. The Role The Director, Translational Biology & Biomarkers will be responsible for advancing biomarker strategies and translating scientific insights into actionable clinical outcomes. This leader will build the Biomarkers strategy to support Sail’s transition into clinical development, building internal capabilities while leveraging CRO capabilities. This individual will bring broad technical expertise in bioassay development and bioanalytical measurements, qualification/validation, and data interpretation. The role will oversee development of PK, immunogenicity, and pharmacodynamic/bioassays across discovery and clinical stages aligned with the company’s expanding portfolio. In addition to supporting the lead program advancing to clinical development, the individual will also guide bioassay needs across several additional programs to increase assay standardization and robustness across functions.

Requirements

PhD or MD in Immunology, Cell Biology, or related scientific discipline with 10+ years of experience in a Biotech or Pharmaceutical setting; or equivalent combination of education and experience.
Demonstrated expertise in bioassay development, qualification, validation, and regulatory submission support.
Deep knowledge of PK, immunogenicity, cell-based functional assays, potency assays, and biomarker assay development.
Strong understanding of drug development, regulatory processes, and clinical development, including GLP/GCLP bioanalytical expectations.
Proven experience building and leading scientific teams in a growing biotech environment.
Strong strategic thinking, sound judgment, and ability to operate effectively in a fast-paced, matrixed organization.
Track record of advancing multiple programs simultaneously and implementing creative, solution-oriented strategies.
Excellent interpersonal, communication, and organizational skills.

Responsibilities

Own and execute clinical biomarker plans in alignment with program team goals and clinical function.
Design and execute Sail’s biomarker strategies to support a clinical-stage portfolio, including biomarker-driven clinical study design and incorporation of biomarker endpoints for decision-making in early-stage clinical trials.
Provide scientific and technical leadership for development, qualification, validation, and lifecycle management of PK, ADA, neutralizing antibody, cell-based potency, and pharmacodynamic assays.
Ensure assays are fit-for-purpose and aligned with regulatory expectations (GLP/GCLP), in close collaboration with Preclinical Pharmacology, Regulatory, Clinical, and Quality teams.
Oversee internal and external assay development activities, including CRO and central laboratory management, ensuring scientific rigor, data integrity, and timeline adherence.
Review and approve assay validation plans, reports, and work orders from analytical laboratories.
Analyze and interpret biomarker and immunogenicity data and communicate biological and clinical implications to support program decisions.
Define data transfer specifications in collaboration with translational science, data management, and data science teams to ensure high-quality clinical biomarker datasets.
Represent the Biomarker function at internal and external meetings and provide project status updates related to biomarker deliverables.
Partner with Clinical Operations to ensure appropriate collection, shipment, and analysis of clinical samples.
Coordinate with internal and external stakeholders (CROs, central labs, clinical sites) to address specimen-related and assay-related issues.
Manage timelines, budgets, and external partnerships for bioanalytical and biomarker programs.
Advise senior and matrixed leaders on bioanalytical risk, strategy, and development trade-offs.