Associate Director of Clinical Pharmacology

Xyzagen • Pittsboro, NC

2d • Hybrid

About The Position

Xyzagen (ZiZaGen) is seeking a highly skilled scientist with a background in Pharmaceutical Sciences to be Associate Director of Clinical Pharmacology. This role is designed for a professional who will lead the design, execution, and interpretation of clinical pharmacology studies (Phase I–III), develop and implement quantitative pharmacometric strategies to support dose selection and regulatory submissions. This position can either have experience in clinical development of biologics or small molecules. If the individual has experience in small molecule drug development then they should also be experienced in in vitro ADME studies. This position would lead our in vitro ADME solutions internally, and provide strategic drug development and regulatory consulting to a diverse client base ranging from NIH-funded startups to mid-sized pharmaceutical companies in small and large molecules. If the individual has large molecule experience then they should be experienced in large molecule bioanalytical assay development and validation for PK and ADA assays. Xyzagen is a contract research lab supporting pharmacokinetics, ADME, in vivo PK, small and large molecule bioanalytical, pharmacology, and non-GLP safety assessments. We are also a drug development consultancy providing regulatory advice to clients across nonclinical and clinical disciplines. At Xyzagen, we accelerate medicines to patients by partnering with life science innovators, contributing to multiple FDA submissions and approvals since 2018. Xyzagen has provided strategic advice to early NIH funded biotechs, small and mid-size pharma and venture capital firms. At Xyzagen, we accelerate medicines to patients by partnering with life science innovators. Since 2018, we have worked with over 100 different innovators worldwide and have helped in the approval of multiple new therapeutics by the FDA. Xyzagen also conducts its own research on Kv7 channel openers within the therapeutic areas of Neurology, Seizures and Pain. Why Join Xyzagen? Our multidisciplinary team helps clients make better decisions through: Cost-effective, data-driven drug development strategies Rapid execution of nonclinical pharmacokinetic and safety studies Integrated support spanning laboratory research, pharmacometrics, and regulatory consulting At Xyzagen, you'll work on a wide variety of therapeutic areas, molecular modalities, and modeling challenges while contributing directly to client success. In 2026, we are expanding our laboratory and office space from 5,000 to 11,000 square feet, creating new opportunities to support the growing life-science community and expanding our scientific capabilities in nonGLP bioanalysis, pharmacokinetics, pharmacology and safety assessments.

Requirements

• M.S., Ph.D., Pharm.D., or M.D. in Clinical Pharmacology, Pharmacokinetics, or related scientific discipline.
• Minimum of 5–8 years of progressive experience in clinical pharmacology, pharmacometrics, or drug development within the pharmaceutical or biotechnology industry.
• Deep understanding of regulatory guidelines (FDA, EMA, ICH) and their application to nonclinical and clinical programs.
• Proficiency in noncompartmental PK and principals of pharmacokinetics and experience in PK/PD modeling and simulation software (e.g., Phoenix WinNonlin, NONMEM, R, or Monolix).
• Demonstrated experience in designing, overseeing and interpreting clinical pharmacology studies (Phase I–III), including drug-drug interaction (DDI), and specialized population studies.
• Experience in the design and interpretation of in vitro ADME assays in support of small molecule drug development.
• Exceptional leadership, communication, and presentation skills with the ability to work effectively within multidisciplinary, cross-functional project teams.
• Ability to provide data-driven insights that support informed decision-making across various therapeutic areas and molecular modalities.
• Applicants must be legally authorized to work in the United States.
• Xyzagen is unable to sponsor employment visas or transfer existing work visas.

Nice To Haves

• Experience in clinical development of biologics or small molecules.
• If the individual has experience in small molecule drug development then they should also be experienced in in vitro ADME studies.
• If the individual has large molecule experience then they should be experienced in large molecule bioanalytical assay development and validation for PK and ADA assays.

Responsibilities

• Lead the design, execution, and interpretation of clinical pharmacology studies (Phase I–III), including first-in-human, DDI, and special population trials
• Develop and implement quantitative pharmacometric strategies using population PK, PK/PD, and PBPK modeling to support dose selection and regulatory submissions
• Provide strategic drug development and regulatory consulting to a diverse client base ranging from NIH-funded startups to mid-sized pharmaceutical companies
• Author and review clinical pharmacology sections of regulatory documents, including INDs, NDAs, and Investigator Brochures
• Ability to translate complex pharmacometric data into clear development strategies to support client R&D decision-making
• Represent Xyzagen as a subject matter expert in client meetings and business development initiatives to expand scientific capabilities
• Provide guidance and supervise associate scientists and scientists within the team
• Assist with business development efforts to generate and engage with new clients and act as the primary point for contact for existing clients.

Benefits

• Medical, dental, and vision insurance
• 401(k) with Safe Harbor match, profit sharing, and defined benefit retirement plan
• Company-paid holidays, including closure between Christmas and New Year's
• Two weeks of paid time off

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level