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™ oreRNA), and an industry-leading platform of programmable nanoparticles,utilizingnatural components, to unlock comprehensive programming of medicines for the first time. By leveragingcutting-edgeeRNAand nanoparticle deployment technology, Sail is also making unparalleled use of AI techniques to identifyand design fully programmable medicines that are potent, targeted, versatile, and tunable. Sail was founded by Flagship Pioneering.
The Role
The Director, Translational Biomarkers will be responsible for advancing biomarker strategies and translating scientific insights into actionable clinical outcomes. This person will have responsibility for growing and developing their function commensurate with the growth and needs of the company, bringing broad technical expertise in clinical bioanalytical assay strategy, development, validation/qualification, and data interpretation.
Responsibilities
- Own and execute clinical biomarker plans in alignment with the project team's goals including contributions to laboratory manuals, informed consents, analytical plans, and SOWs.
- Design and execution of Sails biomarker strategies to support a future clinical stage portfolio, including the biomarker driven clinical study design, implementation of novel technologies and incorporation of biomarker endpoints for decision making in early-stage clinical trials.
- Provide scientific leadership for clinical bioanalytical assays, including pharmacokinetic (PK), immunogenicity (ADA), and pharmacodynamic/biomarker assays, ensuring assays are fit-for-purpose and aligned with regulatory expectations, in close collaboration with PK/PD and clinical pharmacology colleagues.
- Lead the development, qualification, and validation of biomarker, PK, and immunogenicity assays through external partners and CROs, and ensure implementation using appropriate clinically validated methodologies.
- Oversee all technical aspects of biomarker assay development and implementation working closely with external partners, analytical labs, CROs to ensure that the development of assays and timelines are delivered.
- Review and approve work order of the central analytical lab to validate the assay.
- Continuously evaluate newer, innovative technology platforms and applicability to clinical biomarker testing.
- Partner with Biomarker Operations Manager and Clinical Operations team members to assure collection and shipment of biomarker clinical samples from the clinical sites/central laboratory to analysis laboratories.
- Coordinate with internal and external stakeholders (CROs/clinical sites) to address clinical specimen-related issues in a timely manner. Manage timelines, analyze, and interpret clinical biomarker and immunogenicity data.
- Analyze and interpret the biomarker and immunogenicity data and communicate he biological and clinical implications to support program decision-making.
- Define data transfer specifications by gathering input from translational science leads, data management, and data scientists to ensure delivery of high-quality clinical biomarker datasets.
- Represent the Biomarker Group at internal and external meetings, provide frequent project status updates related to biomarker deliverables, effectively interface, and collaborate cross-functional teams.
Qualifications
- PhD or MD in Immunology, Molecular 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 biomarker discovery, validation, translation, and development.
- Strong understating of drug development, regulatory processes, and clinical development.
- Proven ability to advise senior & matrixed leaders effectively.
- Excellent interpersonal and organizational skills, along with a demonstrated. ability to think strategically and critically and consistently exercise sound judgment.
- Track record of coordinating multiple programs simultaneously, moving projects forward, and developing and implementing creative, solution-oriented strategies while anticipating future demands and opportunities.
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.
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