Associate Director of Clinical Pharmacology

Xyzagen, Inc.; North Carolina; Hybrid; USD 120.000 - 156.000; Vollzeit

Benefits dieser Stelle

Medical, dental, and vision insurance

401(k) with Safe Harbor match, profit 

Two weeks of paid time off

Company-paid holidays

Zusammenfassung

Xyzagen, Inc. in Pittsboro, NC is seeking an Associate Director of Clinical Pharmacology to lead design, execution, and interpretation of Phase I-III studies and to develop quantitative pharmacometric strategies for dose selection and regulatory submissions.

The role supports both small and large molecule programs, may involve in vitro ADME, PK/PD modeling, and cross-functional leadership across early and late-stage development teams.

Qualifikationen

• Advanced degree required in clinical pharmacology, pharmacokinetics or related field.
• 5–8 years of progressive clinical pharmacology/pharmacometrics experience in pharma/biotech.
• Strong regulatory knowledge (FDA/EMA/ICH) and experience with regulatory documents.
• Experience in PK/PD modeling and simulation software.

Aufgaben

• Lead the design, execution, and interpretation of clinical pharmacology studies (Phase I-III).
• Develop quantitative pharmacometric strategies to support dose selection and regulatory submissions.
• Provide strategic drug development and regulatory consulting to diverse clients.
• Author and review regulatory sections (INDs, NDAs, Investigator Brochures).
• Represent Xyzagen in client meetings and business development initiatives.

Kenntnisse

Leadership

Strategic thinking

Communication

Cross-functional collaboration

Ausbildung

MS, PhD, PharmD, or MD in Clinical Pharmacology, Pharmacokinetics, or related discipline

Tools

Phoenix WinNonlin

NONMEM

R

Monolix

Jobbeschreibung

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.

Job Responsibilities:

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

Qualifications:

• 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.
• This position and compensation is targeted for an Associate Director but may be adjusted depending on the individual’s qualifications.

Physical Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• While performing the duties of this Job, the employee is frequently required to sit or stand for extended periods of time; use fine and gross motor hand skills in ensuring analytical equipment is maintained in operation.
• Must be able to speak and hear appropriately to communicate effectively with each associate or vendor.
• Specific vision abilities required by this job include close, distance and peripheral vision with the ability to adjust and focus.
• The employee on occasion will be required to lift and/or move up to 40 pounds.

Working Conditions:

• Laboratory and office environment
• Typical noise level in the office is mild to moderate

What We Offer:

• The compensation for this position will range from $120,000 to $156,000 depending on individual’s qualifications.
• Salary range depending on qualifications and experience
• 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
• The position is preferably local onsite in Pittsboro, NC. Candidates applying for remote work will be considered but preference will be made for local candidates.

Applicants must be legally authorized to work in the United States. Xyzagen is unable to sponsor employment visas or transfer existing work visas.