Director, Nonclinical Development (Toxicology)

Location: Florham Park, New Jersey, USA; US and Puerto Rico residents only

Annual salary: $152,300–$259,200

Company

hirify.global is a global healthcare company focused on Women's Health, biosimilars, General Medicines, and expanding access to health solutions.

What you will do

• Serve as the nonclinical representative on asset development teams supporting product development and lifecycle management.
• Author and review nonclinical CTD modules, briefing books, regulatory communications, investigator brochures, and product labels.
• Provide toxicology, pharmacology, and DMPK expertise for products and development teams.
• Partner with Regulatory, Safety, Pharmacovigilance, CMC, Occupational Safety, Medical Affairs, and Business Development.
• Evaluate manufacturing impurities, degradants, and extraneous matters and conduct toxicological risk assessments.
• Support regulatory submissions, Health Authority interactions, annual reporting, license renewals, and responses to regulatory inquiries.

Requirements

• PhD, DVM, or equivalent degree in pharmacology, biology, physiology, biochemistry, chemistry, toxicology, or a related science.
• At least 10 years of pharmaceutical or biotechnology industry experience with broad nonclinical expertise.
• Extensive experience with late-stage drug development, lifecycle management, toxicology, DMPK, and pharmacology.
• Experience authoring and reviewing nonclinical regulatory dossiers, including NDAs, product labels, briefing books, and response documents.
• Knowledge of nonclinical, impurity-related regulatory guidelines and GxP requirements.
• Ability to communicate complex scientific concepts clearly and collaborate effectively in project teams.

Nice to have

• Board certification in toxicology, such as DABT or ERT.
• Experience working in global project teams.

Culture & Benefits

• Regular employment status with one opening.
• US benefits include retirement savings, paid vacation and holidays, caregiver, parental and medical leave.
• Medical, prescription drug, dental, and vision coverage is available under applicable plans.
• Work is governed by Good Laboratory Practices, Good Clinical Practice, and hirify.global standard operating procedures.
• Employees must satisfy applicable travel, credentialing, and vaccination requirements.