Director of Nonclinical Pharmacokinetics and Clinical Pharmacology

Position Summary:

We are seeking a highly motivated and experienced leader in Nonclinical Pharmacokinetics (PK) and Clinical Pharmacology to join our dynamic team. The successful candidate will play a critical role in driving the strategic planning, design, and execution of pharmacokinetics and clinical pharmacology studies to support the development of our therapeutic programs from preclinical to clinical stages.

Key Responsibilities:

• Develop and implement nonclinical PK and clinical pharmacology strategies to support the progression of drug candidates through the pipeline.
• Lead the design, execution, and interpretation of nonclinical PK, ADME, and PK/PD studies in collaboration with internal and external stakeholders.
• Provide clinical pharmacology input for first-in-human, proof-of-concept, and pivotal clinical trials, including dose selection and optimization strategies.
• Collaborate with toxicology, regulatory, and clinical teams to ensure alignment on program goals and compliance with regulatory requirements.
• Manage relationships with CROs and other external vendors to support study execution.
• Drive the development of modeling and simulation efforts (e.g., PBPK, population PK, exposure-response analyses) to inform decision-making.
• Stay up to date on advancements in PK and clinical pharmacology to implement innovative approaches.

Minimum Requirements:

• Ph.D., Pharm.D., or equivalent degree in Pharmacokinetics, Clinical Pharmacology, Pharmaceutical Sciences, or a related field.
• At least 10 years of experience in nonclinical PK, clinical pharmacology, or related functions within the pharmaceutical or biotechnology industry.
• Strong expertise in PK, ADME, PK/PD modeling, and clinical pharmacology strategies.
• Proven track record of contributing to INDs, NDAs, and other regulatory submissions.
• Preferred candidates with experience in oligonucleotide development and a strong understanding of regulatory requirements and guidance in pharmacokinetics (PK) and clinical pharmacology.
• Proficiency in modeling and simulation tools (e.g., WinNonlin, NONMEM, MetLab, or similar software).
• Excellent communication, presentation, and interpersonal skills, with a strong ability to work collaboratively across disciplines.
• Attention to detail and quality, and ability to deliver work on time.
• Strong problem-solving and decision-making skills, with the ability to manage multiple projects and priorities.
• Demonstrated ability to work successfully in a fast-paced and dynamic work environment, with the agility to quickly pivot in the face of new data and/or strategic directions.

We are not accepting agency resumes at this time.

City Therapeutics is an Equal Opportunity and Affirmative Action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.