Associate Director, Stability Lead Development & Clinical

Location: Norwood, Massachusetts, United States. Hybrid 70/30 work model with 70% in-office collaboration.

Company

hirify.global develops mRNA-based medicines and vaccines through a technology platform spanning mRNA science, delivery technology, manufacturing, and clinical development.

What you will do

• Define and lead phase-appropriate stability strategies across development, clinical, and commercial mRNA programs.
• Design and oversee stability protocols supporting IND/CTA submissions, pivotal readiness, registration, post-approval commitments, and commercial lifecycle initiatives.
• Review stability data using statistical evaluation and trending analysis to support shelf-life, expiry, storage-condition, and risk-based decisions.
• Lead shelf-life modeling, comparability assessments, change-impact assessments, OOS/OOT investigations, and formal risk evaluations.
• Author and review stability sections for regulatory submissions and responses, and support health authority interactions.
• Partner with Analytical Development, Quantitative Sciences, Process Development, Quality, Regulatory, Clinical Supply, Supply Chain, and Commercial teams while mentoring colleagues in a matrix environment.

Requirements

• Degree in life sciences, chemistry, engineering, pharmaceutical sciences, or a related technical discipline.
• 12 years of relevant experience with a bachelor’s degree, or 5 years of relevant experience with a PhD.
• Significant experience leading stability strategy for biologics, vaccines, or other complex drug products.
• Experience authoring stability content for major regulatory submissions and supporting health authority interactions.
• Experience with statistical analysis, stability trending, scientific interpretation of complex datasets, expiry dating, and storage-condition decisions.
• Strong cross-functional leadership, communication, risk assessment, investigation, and process-improvement skills in a CMC or technical development organization.

Nice to have

• Advanced degree in a relevant field with 7 or more years of relevant industry experience.
• Experience with development and clinical programs or post-approval and commercial lifecycle management.
• Experience using digital tools, advanced analytics, and emerging generative AI capabilities.

Culture & Benefits

• In-person collaboration, direct mentorship, and a 70/30 in-office work model.
• Healthcare coverage and voluntary benefit programs.
• Fitness, mindfulness, mental health, and broader well-being resources.
• Family planning support, including fertility, adoption, and surrogacy benefits.
• Paid vacation, volunteer days, sabbatical, global recharge days, and discretionary year-end shutdown.
• Savings and investment opportunities plus location-specific benefits.