Senior Director, Clinical Pharmacology (Biotech)

Location: San Diego, California, United States; up to 10% travel

Base pay: $250,000–$300,000 per year, plus bonus, equity, and comprehensive benefits

Company

hirify.global Therapeutics is a clinical-stage precision medicine company developing next-generation therapeutics for immunology, inflammation, and immune-mediated inflammatory and fibrotic diseases.

What you will do

• Serve as Study Director for several concurrent Phase 1 studies, including first-in-human, dose-escalation, relative bioavailability, formulation or device bridging, drug interaction, and special population studies.
• Author and amend protocols, define dose-escalation and stopping rules, and develop PK/PD and biomarker sampling schemes.
• Lead day-to-day collaboration with Phase 1 units, investigators, CROs, vendors, Clinical Operations, and cross-functional study teams.
• Oversee safety, PK, PD, biomarker, and data-quality review from first subject dosed through database lock.
• Lead study analysis and reporting, including noncompartmental PK analysis, PK/PD summaries, clinical study reports, and presentations to program teams and governance.
• Support IND maintenance, regulatory briefing documents, later-phase clinical pharmacology plans, Phase 2 dose selection, in-licensing diligence, process improvement, and team development.

Requirements

• PhD, PharmD, or equivalent experience in clinical pharmacology, pharmacology, pharmaceutical sciences, or a related discipline.
• 10+ years of biotech or pharmaceutical industry experience in early clinical development, with demonstrated delivery of Phase 1 studies as the accountable sponsor lead.
• Experience serving as Study Director or equivalent sponsor lead for first-in-human dose-escalation studies in healthy volunteers and/or patients.
• Experience authoring and amending clinical protocols and maintaining INDs, including amendments, annual reports, DSURs, and responses to health authority requests.
• Working knowledge of PK/PD and model-informed drug development, including sampling design, noncompartmental analysis, exposure–response interpretation, and review of pharmacometric deliverables.
• Strong understanding of ICH Good Clinical Practice, Phase 1 regulatory requirements, safety reporting, protocol documentation, inspection readiness, cross-functional leadership, and project and financial management.

Nice to have

• Hands-on modeling experience with Phoenix WinNonlin, NONMEM, or R.
• Experience in immunology or inflammation and across biologic and small-molecule modalities.
• Experience with later-phase clinical pharmacology deliverables, Phase 2 dose selection, or in-licensing due diligence.
• Familiarity with bioanalysis, biomarkers, biostatistics, data management, toxicology, and regulatory processes.

Culture & Benefits

• Hands-on, delivery-oriented role in a small team with end-to-end ownership and a bias toward action.
• Collaborative leadership culture based on teamwork, delegation, trust, and mutual respect.
• Comprehensive benefits, bonus eligibility, and equity participation.
• Opportunity to contribute to hiring, onboarding, mentoring, and internal process improvement.