Associate Director, Clinical Pharmacology

The role

The Associate Director of Clinical Pharmacology will design, execute, analyze, and interpret clinical pharmacology strategies for RNAi therapeutic programs. This role provides scientific leadership for PK, PD, exposure-response, and dose selection activities from first-in-human studies through late-stage development.

What you will do

• Lead development and execution of clinical pharmacology strategies for RNAi therapeutic clinical programs.
• Lead and execute model-informed drug development activities including population PK, exposure-response, PBPK, and mechanistic PK/PD modeling.
• Contribute to clinical protocol design, statistical analysis plans, clinical study reports, and investigator brochures.
• Author and review clinical pharmacology sections of regulatory documents including INDs, briefing packages, meeting requests, and marketing applications.
• Participate in interactions with health authorities and contribute to regulatory strategy discussions.
• Develop dose selection and dose optimization strategies.
• Integrate nonclinical, translational, biomarker, PK/PD, and clinical data to inform clinical development decisions.
• Review emerging clinical data and communicate pharmacology insights to project teams and senior leadership.
• Ensure clinical pharmacology plans align with current regulatory expectations and industry best practices.

Required qualifications

• PhD, PharmD, MD, or equivalent advanced degree in Clinical Pharmacology, Pharmaceutical Sciences, Pharmacokinetics, Pharmacometrics, Biomedical Engineering, or a related discipline.
• 7+ years of relevant industry experience in clinical pharmacology or pharmacometrics.
• Demonstrated experience supporting early and/or late-stage clinical development programs.
• Experience leading clinical pharmacology activities across multiple development programs and regulatory interactions.
• Hands-on experience with population PK modeling and exposure-response analyses for dose recommendation and optimization.
• Experience working with external CROs and pharmacometric vendors.
• Knowledge of regulatory expectations related to clinical pharmacology and model-informed drug development.
• Experience contributing to CTA, IND, NDA, BLA, or equivalent regulatory submissions.
• Excellent scientific communication and presentation skills.
• Ability to influence cross-functional teams in a fast-paced biotechnology environment.
• Prior participation in FDA, EMA, or other global regulatory agency interactions.

Nice to have

• Familiar with translational biomarkers and precision medicine approaches.
• Experience in oligonucleotide therapeutics, i.e. siRNA, antisense, gene editing, or other nucleic acid-based modalities.

Benefits

• Annual bonus
• Equity compensation
• Competitive benefits package

Before you apply

• City Therapeutics is accepting applications from direct candidates only.

About the company

City Therapeutics is advancing a next-generation platform for RNAi medicines designed to unlock the full therapeutic potential of gene silencing. They are building a pipeline of transformative medicines for patients with serious diseases.