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Associate Director, Clinical Pharmacology

RETROPHIN, INC.

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At a glance

Compensation
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Location
Remote · US
Work Authorization
Not specified

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Job overview

The Associate Director, Clinical Pharmacology leads clinical pharmacology strategy across clinical programs, integrating pharmacokinetics, pharmacodynamics, and drug-drug interaction assessments. The role provides guidance to project teams, supports study design and regulatory submissions, and communicates strategies to senior management, regulators, and external peers. It partners with research, bioanalytical, clinical, regulatory, and project management functions to deliver input at key development decisions.

Skills & qualifications

RequiredNice to have

Skills

PharmacokineticsPharmacodynamicsDrug-Drug Interaction AssessmentClinical Pharmacology StrategyPK/PD ModelingBiopharmaceuticsPharmacometricsScientific Project LeadershipProject Management

Qualifications

Ph.D. Or EquivalentPh.D.+4 or Pharm.D.+8 YearsMultiple Therapeutic or Functional AreasRange of Development PhasesScientific Project Leadership or Related Experience

Full job description

Department: 107600 Clinical Pharmacology Location: San Diego, USA- Remote Be a part of a global team that is inspired to make a difference in the lives of people living with rare disease. At Travere Therapeutics, we recognize that our exceptional employees are vital to our success. We are a dedicated team focused on meeting the unique needs of rare patients.Our work is rewarding - both professionally and personally - because we are making a difference. We are passionate about what we do. We are seeking talented individuals who will thrive in our collaborative, diverse, fast-paced environment and share in our mission - to identify, develop and deliver life-changing therapies to people living with rare disease. We stick by our values centered on patients, courage, community, and collaboration to pursue our vision of becoming a leading biopharmaceutical company dedicated to the delivery of innovation and hope to patients in the global rare disease community. At Travere Therapeutics, we are in rare for life. We continue to courageously forge new paths as we move toward a common goal of elevating science and service for rare patients. Position Summary: The Associate Director, Clinical Pharmacology will be responsible for the design, leadership, and implementation of clinical pharmacology strategies across Travere clinical programs. In this role, you will communicate key Clinical Pharmacology strategies to senior management, regulatory agencies, and external peers. Utilizes scientific expertise to provide appropriate interpretation of data and relates implications of results to management. Serves as liaison to other departments/divisions for any study/project needs. Understands linkages across businesses and understands the impact of business decisions and solutions. 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 RandD 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. Education/Experience Requirements: * 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. * Scientific project leadership or related experience. * P roject management skills such as... For full info follow application link. Travere Therapeutics, Inc. is an EEO/AA/Veteran/Disability Employer

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