City Therapeutics

Associate Director, Clinical Pharmacology

Cambridge, Massachusetts, United States · Director

Sponsorship not specified$174k-$196kDetected 49 days ago

Data ScienceStatisticsPharmacologyFDA RegulatoryCRISPRLeadershipCommunicationCollaborationBiostatisticsRegulatory Affairs

About the role

Your actual base salary will be based on several factors, including job-related skills, experience, internal equity, relevant education or training, and market dynamics.
If you're driven by discovery, pace, and purpose-welcome to City.
Our working model is clear: we work onsite at our Kendall Square offices five days per week.

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.
Develop dose selection and dose optimization strategies to support clinical development and regulatory submissions.
We collaborate intensely, with candor and optimism, taking ownership and celebrating the journey together.
In Person, By Design
We believe in developing talent, and that happens best when we're together.
We believe diverse teams drive better science.

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.
Ability to influence cross-functional teams in a fast-paced biotechnology environment.
Experience in oligonucleotide therapeutics, i.e. siRNA, antisense, gene editing, or other nucleic acid-based modalities.
Excellent scientific communication and presentation skills.
Prior participation in FDA, EMA, or other global regulatory agency interactions.
Familiar with translational biomarkers and precision medicine approaches.

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:

Participate in interactions with health authorities and contribute to regulatory strategy discussions.

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.
At City, we believe that science and culture thrive together, and that happens best in person.
We welcome applicants from all backgrounds and experiences who share our mission to bring transformative RNAi medicines to patients.

This listing is sourced directly from City Therapeutics's careers page and normalized into a canonical job model.