Associate Director, Clinical Pharmacology (Biotech)

Location: Hybrid role based in Thousand Oaks, CA or San Francisco, CA

Company

hirify.global is an early-stage biotechnology company developing non-opioid medicines for pain and pain-related syndromes, with programs ranging from preclinical to late phase.

What you will do

• Develop clinical pharmacology strategies for multiple clinical and pre-IND programs from first-in-human studies through registration.
• Design and oversee clinical pharmacology studies for small-molecule programs.
• Lead studies of increasing complexity, including planning and conduct oversight.
• Analyze, interpret, and author protocols, study reports, Investigator’s Brochures, and clinical pharmacology sections of regulatory submissions.
• Interact with US and ex-US regulatory agencies as needed.
• Oversee consultants and vendors supporting PK, PKPD, and clinical assay development.

Requirements

• 8+ years of clinical pharmacology experience supporting early development in a biotechnology or pharmaceutical organization.
• Robust experience with small-molecule clinical pharmacology is required.
• Proficiency with modern PK analysis software, such as Phoenix WinNonlin, is required.
• Experience designing and conducting multiple types of Phase 1 studies, including FIH, DDI, FE, and rBA studies.
• PharmD or PhD in a relevant discipline is preferred.
• Strong interpersonal, communication, independent-working, and cross-functional influence skills.

Nice to have

• Knowledge of regulatory requirements for clinical pharmacology.
• Experience in pain management therapeutic areas.
• Experience with regulatory submissions in early and late development.

Culture & Benefits

• Work in a dynamic and fast-paced early-stage biotechnology environment.
• Contribute to patient-focused development of novel pain therapies.
• Collaborate with an experienced management team and Board of Directors.
• Company values include honest science, patient focus, and innovation.