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

Associate Director, Clinical Pharmacology

Remote

Associate Director, Clinical Pharmacology

City Therapeutics is advancing a next-generation platform for RNAi medicines designed to unlock the full therapeutic potential of gene silencing. By combining innovative delivery technologies with deep expertise in RNA biology, we are building a pipeline of transformative medicines for patients with serious diseases. We are seeking a highly motivated and scientifically rigorous Clinical Pharmacology Scientist to join our dynamic and growing Translational Sciences Team to help shape the clinical development strategy of our growing portfolio.

The Associate Director of Clinical Pharmacology will play a critical role in the design, execution, analysis, and interpretation of clinical pharmacology strategies across City Therapeutics' development programs. This individual will report to the Head of Clinical Pharmacology and Pharmacokinetics (CPPK), and provide scientific leadership for pharmacokinetic (PK), pharmacodynamic (PD), exposure-response, and dose selection activities from first-in-human studies through late-stage clinical development.

The successful candidate will work in a highly cross-functional environment, partnering closely with Clinical Development, Regulatory Affairs, Clinical Operations, Biostatistics, Data Science, CMC and external collaborators to drive data-driven decision making and advance clinical development.

Key Responsibilities

• Lead development and execution of clinical pharmacology strategies for RNAi therapeutic clinical programs.
• Lead and execute model-informed drug development (MIDD) activities, including population PK, exposure-response, PBPK, and mechanistic PK/PD modeling, either independently or in collaboration with quantitative scientists, to support regulatory interactions and development planning.
• 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 to support clinical development and regulatory submissions.
• 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.

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

Compensation
The base salary range provided reflects our current estimate of what we anticipate paying for this position. Your actual base salary will be based on several factors, including job-related skills, experience, internal equity, relevant education or training, and market dynamics. In addition, you will be eligible for an annual bonus, equity compensation, and a competitive benefits package. Pay range is $174,000 to $196,000

Why You’ll Love Working Here

At City, you’ll be part of a team that’s as ambitious as it is collaborative. We’re building an organization that is united by our values:

• Courage: We seek out the unknown, challenge boldly, and fight for patients.
• Innovation: Curiosity drives us to push the boundaries of what’s possible.
• Tempo: We move fast and with purpose. Patients can’t wait, and neither will we.
• Yes: We collaborate intensely, with candor and optimism, taking ownership and celebrating the journey together.

If you’re driven by discovery, pace, and purpose—welcome to City.

Our Working Model: In Person, By Design

At City, we believe that science and culture thrive together, and that happens best in person. Our working model is clear: we work onsite at our Kendall Square offices five days per week.

This choice reflects our belief that great science and cultures run on connection, fairness, and growth:

• Connection: Face time matters. Building an enduring biotech company is about people, science, and strategy. Working side by side sharpens ideas, accelerates feedback, and fuels innovation for patients.
• Fairness: One model for all. Every voice counts, and fairness depends on shared experience. We hold ourselves to one standard across all levels and functions.
• Growth: Learning moves faster in person. Growth comes from conversation, observation, and mentorship. We believe in developing talent, and that happens best when we’re together.

We also know that life isn’t always predictable. When individual needs arise, we’re flexible and supportive and work together to balance home life with life at City.

We believe diverse teams drive better science. We welcome applicants from all backgrounds and experiences who share our mission to bring transformative RNAi medicines to patients.

City Therapeutics is an Equal Opportunity and Aff…