Clinical Pharmacology Strategy Lead (Associate Director)

Travere Therapeutics; Oklahoma City (OK); Hybrid; USD 150,000 - 195,000; Full time

Benefits offered by this job

Premium health benefits

Stock options

Paid time off

Job summary

You will provide clinical pharmacology input for regulatory submissions, mentor project teams, and partner with Regulatory, Research, and Clinical groups. Travel up to 10% domestically and internationally.

The role requires a Ph.D. or PharmD with extensive leadership in PK/PD, Biopharmaceutics, and Pharmacometric activities, with a track record across multiple development phases in rare disease therapy.

Qualifications

• Ph.D. degree or equivalent required.
• 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.
• Scientific project leadership or related experience.
• Project management skills such as scope management, progress tracking/driving as well as time management.
• Participates in initiatives and advancement of Clinical pharmacology.
• Clinical pharmacology and therapeutic knowledge in one or more disease areas.
• Experience with incorporation of MIDD strategies into drug development across all phases and responding to questions on dose and regimen justification and study design.

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

PK/PD

Clinical pharmacology

Regulatory submissions

Project leadership

MIDD

Education

Ph.D. degree or equivalent

PharmD with 8+ years

Job description

You will provide clinical pharmacology input for regulatory submissions, mentor project teams, and partner with Regulatory, Research, and Clinical groups. Travel up to 10% domestically and internationally.

The role requires a Ph.D. or PharmD with extensive leadership in PK/PD, Biopharmaceutics, and Pharmacometric activities, with a track record across multiple development phases in rare disease therapy.