Associate Director, Clinical Pharmacology: PK/PD Strategy

Travere Therapeutics; Atlanta (GA); On-site; USD 150,000 - 195,000; Full time

Benefits offered by this job

Premium health insurance

Well-being programs

Retirement plans with company match

Job summary

Travere Therapeutics in San Diego, CA is seeking an Associate Director, Clinical Pharmacology to lead design and execution of pharmacology strategies across clinical programs. You will communicate strategies to senior management, regulatory agencies, and external peers, guiding dose and regimen decisions.

In this role you will oversee PK/PD modeling, dose escalation studies, and regulatory documents such as INDs, CTAs, and NDAs, collaborating with R&D teams to drive evidence generation and

Qualifications

• Ph.D. degree or equivalent required. Equivalent combination of education and applicable job experience may be considered.
• 4+ years of experience required or Pharm D with 8+ years of experience in a relevant field.
• Knowledge and experience in multiple therapeutic and/or functional areas.
• Experience across range of development phases.
• Must have demonstrated leadership competencies in PK/PD, Biopharmaceutics, and Pharmacometric activities from planning, implementation through completion across multiple projects.

Responsibilities

• Lead the development and execution of clinical pharmacology strategy for assigned development programs, integrating pharmacokinetics (PK), pharmacodynamics (PD), and drug-drug interaction assessments into all stages of clinical trials.
• Represent independently Clinical Pharmacology and provide clinical pharmacology support and guidance to clinical stage project teams.
• Develop and oversee the design and implementation of clinical pharmacology studies (e.g., dose escalation, PK/PD modeling) for early drug candidates, ensuring optimal dosing strategies and evidence generation.
• Provide clinical pharmacology input for regulatory submissions such as briefing documents, IND, CTA and NDA.
• Reviews clinical protocols and scientific reports for regulatory filings and anticipates regulatory questions.
• Prepare and input independently appropriate documents or sections of clinical protocols, Investigator Brochures, Clinical Study Reports with respect to Clinical Pharmacology studies or data.
• Closely partner with Research, Bioanalytical, Clinical, Regulatory, Project Management, and other R&D functions.
• This position will play a key role in delivering strategic and well-timed clinical pharmacology input at key decision points along the development path.

Skills

Clinical Pharmacology leadership

PK/PD modeling

Regulatory submissions

Cross-functional collaboration

Education

Ph.D. degree or equivalent

4+ years experience or PharmD with 8+ years

Job description

Travere Therapeutics in San Diego, CA is seeking an Associate Director, Clinical Pharmacology to lead design and execution of pharmacology strategies across clinical programs. You will communicate strategies to senior management, regulatory agencies, and external peers, guiding dose and regimen decisions.

In this role you will oversee PK/PD modeling, dose escalation studies, and regulatory documents such as INDs, CTAs, and NDAs, collaborating with R&D teams to drive evidence generation and