Director, Translational Bioanalytical Sciences (Biotech)

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 annual

Company

hirify.global is a global biopharmaceutical company focused on transforming the lives of patients with serious and rare diseases.

What you will do

• Lead the development, qualification, validation, and implementation of bioanalytical, biomarker, pharmacodynamic, immunogenicity, and translational assays across multiple therapeutic modalities.
• Develop and execute integrated translational bioanalytical and biomarker strategies with Clinical Pharmacology, Clinical Operations, Translational Medicine, Regulatory Affairs, Biometrics, Research, and external collaborators.
• Represent Translational Bioanalytical Sciences on global project teams and contribute to development strategy, regulatory interactions, and key decision-making.
• Oversee regulated and non-regulated testing, clinical study laboratory strategies, sample management, data interpretation, and CRO performance.
• Author and review regulatory and clinical development documents, including INDs, CTAs, NDAs, BLAs, PMAs, Investigator’s Brochures, and Clinical Study Reports.
• Provide scientific leadership, mentorship, vendor governance, and technical guidance across the organization.

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.
• Recognized expertise in advanced bioanalytical technologies, particularly LC-MS/MS, across small molecules, biologics, oligonucleotides, peptides, and emerging multimodality therapeutics.
• Experience with bioanalytical method development, qualification, validation, lifecycle management, and regulated GLP, GCLP, and GCP environments.
• Experience leading scientific teams, global cross-functional programs, CRO partnerships, vendor governance, contract negotiations, and strategic outsourcing.
• Deep knowledge of global regulatory requirements and experience supporting health authority interactions, regulatory filings, and approvals.

Culture & Benefits

• Medical, dental, vision, and mental health coverage, wellbeing reimbursement, and Employee Assistance Program access.
• Paid time off, fertility and family-forming benefits, caregiver support, and flexible work schedules.
• 401(k) plan with company match, annual equity awards, ESPP, and company-paid life and disability insurance.
• Learning programs, LinkedIn Learning access, leadership development, mentorship, networking, and employee resource groups.
• Opportunities for service, recognition, volunteering, and community engagement.