Job Description
About Sail
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 & Bioassay will be responsible for advancing biomarker and bioanalytical strategies and translating scientific insights into actionable clinical outcomes. This leader will establish and grow a Bioassay group 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 and will build and lead a high-performing Bioassay group aligned with the company’s expanding portfolio. In addition to support the lead program advancing to clinical development, the individual will also support bioassay needs across several additional programs and platform projects to increase assay standardization and robustness across functions.
Responsibilities
Bioassay Development & Leadership
Establish, build, and lead Sail’s Translational Biology & Bioassay group, including mentoring and developing scientific staff as the organization grows.
Define, implement and support the bioanalytical assay needs across discovery, IND-enabling, and clinical development stages, including bioassay needs for lead program, and other pipeline and platform programs.
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 Clinical Pharmacology, Regulatory, CMC, 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.
Lead assay technology selection and platform strategy, continuously evaluating innovative technologies and their applicability to Sail’s pipeline (e.g., cell-based functional assays, immunoassays, molecular assays, next-generation platforms).
Establish bioassay governance, documentation standards, and quality systems in collaboration with QA to support regulatory submissions (IND/BLA).
Serve as the bioanalytical subject matter expert in regulatory interactions and contribute to IND submissions and briefing documents.
Translational Biomarker Strategy
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.
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.
Cross-Functional & Operational Leadership
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.
Qualifications
PhD or MD in Immunology, Molecular Biology, Bioanalytical Sciences, 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.
Salary Range: $200,000 - $250,000
Sail Biomedicines is an Equal Opportunity Employer. Sail does not discriminate based on race, religion, color, sex, gender identity, sexual orientation, age, national origin, veteran status, or any other status protected under federal, state, or local law.