Bioanalysis and Biomarker Outsourcing Manager (AI)

Location: Cambridge, MA, United States; onsite. The position is for US and Puerto Rico residents only.

Salary: $122,250.00–$176,583.33 per year

Company

hirify.global is an R&D-driven biopharmaceutical company developing medicines and vaccines through immunoscience, AI, 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.
• Evaluate, onboard, and oversee external vendors, including timelines, budgets, scientific objectives, quality, and performance.
• Monitor assay development, validation, sample analysis, data reconciliation, review, and import activities.
• Coordinate sample collection, handling, logistics, storage, and tracking with central laboratories and clinical operations.
• Lead vendor contracting, governance, audits, regulatory inspections, and cross-functional collaboration with Procurement, Legal, Finance, Quality Assurance, and Regulatory teams.

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.
• 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.
• Must be eligible for the US and Puerto Rico applicant scope and work onsite in Cambridge, MA.

Culture & Benefits

• Supportive, future-focused environment with opportunities for professional growth and international or lateral career moves.
• Rewards package and employee benefits tied to contribution and impact.
• Health and wellbeing benefits, including healthcare, prevention, and wellness programs.
• At least 14 weeks of gender-neutral parental leave.
• Work at the intersection of drug discovery, AI, data, and digital platforms.