Director, Translational Bioanalytical Sciences

Location: Hybrid role based out of the Bridgewater, New Jersey office, with remote work available most of the time and in-person collaboration as needed. Occasional domestic travel of approximately 10% is required.

Salary: $185,000–$252,500 annually

Company

hirify.global is a global biopharmaceutical company developing therapies for patients with serious and rare diseases.

What you will do

• Provide scientific leadership for the development, qualification, validation, and implementation of bioanalytical, biomarker, pharmacodynamic, immunogenicity, and translational assays.
• Develop integrated translational bioanalytical and biomarker strategies with Clinical Pharmacology, Translational Medicine, Regulatory Affairs, Therapeutic Area teams, and other stakeholders.
• Lead regulated and non-regulated bioanalytical testing supporting preclinical and clinical studies across small molecules, biologics, oligonucleotides, peptides, and multimodality therapeutics.
• Support clinical study protocols, statistical analysis plans, laboratory manuals, biomarker plans, sample management strategies, and regulatory documents.
• Interpret bioanalytical and biomarker data to inform dose selection, proof-of-mechanism, patient stratification, and development decisions.
• Oversee CROs and contract laboratories, including vendor selection, governance, performance management, quality, budgets, and timelines.

Requirements

• PhD in Analytical Chemistry, Pharmacokinetics, Pharmacology, Pharmaceutics, Bioanalytical Sciences, or a related discipline.
• At least 10 years of progressive experience in the biopharmaceutical or pharmaceutical industry, including translational sciences, bioanalysis, biomarkers, and clinical development.
• Advanced expertise in bioanalytical technologies, particularly LC-MS/MS, and in method development, qualification, validation, and lifecycle management.
• Experience with regulated and non-regulated studies, including GLP, GCLP, and GCP environments, and with FDA, EMA, ICH, and CLSI requirements.
• Leadership experience developing scientific teams and managing complex, cross-functional, global programs and external partnerships.
• Experience supporting health-authority interactions and regulatory submissions, including INDs, CTAs, NDAs, and BLAs.

Culture & Benefits

• Flexible work schedules with purposeful in-person collaboration.
• Medical, dental, vision, and mental health coverage, wellbeing reimbursement, and Employee Assistance Program access.
• Paid time off, fertility and family-forming benefits, and caregiver support.
• 401(k) plan with company match, annual equity awards, ESPP, and company-paid life and disability insurance.
• Learning programs, mentorship, employee resource groups, service programs, and volunteer opportunities.