Bioanalysis and Biomarker Outsourcing Manager

Location: Cambridge, MA, United States; onsite

Company

hirify.global is an R&D-driven, AI-powered biopharmaceutical company developing medicines and vaccines through immunoscience, data, and digital platforms.

What you will do

• Develop and execute biomarker strategies and plans for preclinical and clinical studies with Biomarker and Precision Medicine teams.
• Manage outsourced biomarker, pharmacokinetic, anti-drug antibody, and bioanalytical activities across study execution.
• Identify, evaluate, onboard, and govern external vendors while overseeing timelines, budgets, scientific objectives, and quality standards.
• Monitor assay development, validation, sample analysis, data reconciliation, review, and import activities.
• Coordinate sample collection, handling, logistics, storage, and tracking with central laboratories, sample management, and clinical operations teams.
• Lead RFIs, RFPs, contracting, negotiations, vendor governance, audits, regulatory inspections, and cross-functional stakeholder collaboration.

Requirements

• Bachelor’s degree in Biology, Biochemistry, Pharmacology, or a related scientific discipline; a Master’s or Ph.D. is preferred.
• At least 5 years of experience in the pharmaceutical, biotechnology, or contract research organization industry.
• Experience in regulated bioanalysis, clinical biomarker development, translational medicine, or a related field is strongly preferred.
• Understanding of GxP requirements and experience with outsourced laboratory or clinical research service providers.
• Strong project management, organizational, problem-solving, communication, collaboration, and stakeholder management skills.
• Ability to work onsite in Cambridge, Massachusetts.

Culture & Benefits

• Supportive, future-focused environment with opportunities for promotion and international career development.
• Rewards package with employee benefits and healthcare, prevention, and wellness programs.
• At least 14 weeks of gender-neutral parental leave.
• Opportunity to contribute to patient-focused drug development and AI-, data-, and digitally enabled research.
• Work focused on improving the speed and effectiveness of drug development for patients worldwide.