Remote Associate Director, Clinical Pharmacology

City Therapeutics; United States; Remote; USD 174,000 - 196,000; Full time

Benefits offered by this job

Competitive compensation

Equity compensation

Benefits package

Job summary

City Therapeutics, a biotech company advancing RNAi medicines, seeks an Associate Director of Clinical Pharmacology to lead PK/PD modeling, MIDD, and dose selection across programs. This remote role reports to CPPK and collaborates with regulatory, clinical operations, and data science teams to drive data-driven decisions.

The role requires a PhD/MD/PharmD or equivalent and 7+ years in clinical pharmacology/pharmacometrics, with strong communication and regulatory submission experience.

Qualifications

• PhD, PharmD, MD, or equivalent advanced degree in Clinical Pharmacology, Pharmaceutical Sciences, Pharmacokinetics, Pharmacometrics, Biomedical Engineering, or related field.
• 7+ years of relevant industry experience in clinical pharmacology or pharmacometrics.
• 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 biotech environment.
• Prior participation in FDA/EMA/global regulatory agency interactions.
• Familiar with translational biomarkers and precision medicine approaches.
• Experience in oligonucleotide therapeutics (siRNA, antisense, gene editing, etc.).

Responsibilities

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

Skills

Clinical pharmacology

PK/PD modeling

MIDD

Regulatory interactions

Cross-functional leadership

Scientific communication

Education

PhD/MD/PharmD or equivalent

7+ years in clinical pharmacology/pharmacometrics

Tools

Population PK

PBPK

Job description

City Therapeutics, a biotech company advancing RNAi medicines, seeks an Associate Director of Clinical Pharmacology to lead PK/PD modeling, MIDD, and dose selection across programs. This remote role reports to CPPK and collaborates with regulatory, clinical operations, and data science teams to drive data-driven decisions.

The role requires a PhD/MD/PharmD or equivalent and 7+ years in clinical pharmacology/pharmacometrics, with strong communication and regulatory submission experience.