Associate Director, Clinical Pharmacology

Location: Hybrid, based in Thousand Oaks, California or San Francisco, California.

Company

hirify.global is a publicly traded, clinical-stage biopharmaceutical company developing innovative non-opioid pain medicines designed to provide effective, rapid-acting pain relief without addiction risk.

What you will do

• Provide clinical pharmacology expertise within clinical development teams for small-molecule programs.
• Formulate clinical pharmacology strategies from first-in-human studies through registration.
• Lead and manage the design and conduct of increasingly complex clinical pharmacology studies.
• Analyze, interpret, and author clinical submission documents, including protocols, 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, and remain accountable for clinical pharmacology activities from discovery through development.

Requirements

• PharmD or PhD in a relevant discipline is preferred.
• 8+ years of experience in clinical pharmacology supporting early development in a biotech or pharmaceutical organization.
• Robust clinical pharmacology experience with small molecules.
• 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, is preferred.
• Knowledge of regulatory requirements for clinical pharmacology is preferred.
• Strong interpersonal skills and the ability to influence development program teams.
• Excellent verbal and written communication skills, with the ability to clearly convey complex concepts to technical and non-technical audiences, are preferred.
• Ability to work independently in a dynamic and fast-paced environment.

Nice to have

• Experience in therapeutic areas related to pain management.
• Experience with regulatory submissions in early and late development.

Culture & Benefits

• Work in clinical development programs ranging from preclinical to late phase.
• Collaborate in a patient-focused, innovation-oriented environment that values honest science.
• Work with an experienced management team and Board of Directors.