Travere Therapeutics

Executive Medical Director, Clinical Development Nephrology

Travere Therapeutics

full-time

Posted on:

Location Type: Hybrid

Location: San Diego • California • United States

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Salary

💰 $285,000 - $385,000 per year

Job Level

Lead

About the role

  • Lead the overall clinical development strategy for assigned program(s) as a key contributor to indication strategy, target product profile, clinical positioning, and lifecycle planning.
  • Serve as the project lead for clinical programs, integrating nonclinical, translational, biomarker, safety, regulatory, and competitive insights into development plans.
  • Design and oversee clinical studies across phases, including protocol concept, eligibility criteria, endpoints, safety monitoring, dose selection, and statistical considerations.
  • Provide leadership for study conduct, including protocol deviation review and data interpretation.
  • Lead analysis and interpretation of clinical data and author or review key documents including protocols, IBs, CSRs, abstracts, manuscripts, and health authority briefing materials.
  • Partner with Biometrics to define analysis strategy and ensure clinically meaningful interpretation of efficacy, safety, PK/PD, and biomarker data.
  • Serve as the project leader for assigned development program(s), driving cross-functional alignment on program goals, timelines, risks, decision points, and resource needs.
  • Lead core team meetings and represent the program at governance forums, providing clear recommendations grounded in data, development risk, and strategic fit.
  • Build integrated development plans in collaboration with cross-functional partners and ensure disciplined execution against milestones.
  • Identify program risks early and develop mitigation strategies spanning clinical, regulatory, operational, and portfolio considerations.
  • Drive scenario planning and decision analyses to support stage-gate and investment decisions.
  • Contribute to global regulatory strategy and represent Clinical Development in interactions with regulatory agencies, including FDA, EMA, and other health authorities.
  • Help prepare for and participate in key regulatory meetings, including end-of-Phase 2 and other milestone interactions.
  • Build and maintain relationships with academic experts, investigators, patient advocacy groups, and other external stakeholders in nephrology and rare disease.
  • Support due diligence and business development activities, including assessment of external assets in nephrology or adjacent rare disease areas.
  • Partner closely with Clinical Operations to ensure study designs are executable and enrollment strategies are realistic for rare disease settings.
  • Collaborate with Non-Clinical teams to incorporate mechanistic and disease-relevant endpoints into development programs.
  • Productively interface with Clinical Pharmacology, Pharmacovigilance, CMC, HEOR, Medical Writing, and additional project functional leads not previously listed.
  • Work with Medical Affairs and Commercial colleagues to align development plans with future evidence-generation needs and patient/community insights.
  • Mentor junior project team members and contribute to building a high-performing clinical development organization.
  • Model strong enterprise leadership, balancing program advocacy with portfolio-level thinking.

Requirements

  • MD, DO, or equivalent medical degree required
  • 10+ years of biotechnology and/or pharmaceutical industry experience in clinical development, with progressive leadership responsibility
  • Prior experience leading clinical programs in nephrology, rare disease, or closely related therapeutic areas strongly preferred
  • Demonstrated experience serving as a program or project leader in a cross-functional drug development environment
  • Strong understanding of clinical trial design, dose selection, safety assessment, endpoint strategy, and interpretation of complex clinical datasets
  • Experience with regulatory submissions and health authority interactions
  • Track record of leading development strategy through major inflection points such as IND, proof-of-concept, end-of-Phase 2, and/or registrational planning
  • Deep appreciation for the unique challenges of rare disease development, including small populations, site selection, natural history, endpoint selection, and patient engagement.
  • Excellent communication and influence skills, with the ability to synthesize complex issues for senior leaders and governance bodies.
Benefits
  • premium health
  • financial, work-life and well-being offerings for eligible employees and dependents
  • wellness and employee support programs
  • life insurance
  • disability
  • retirement plans with employer match
  • generous paid time off
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
clinical development strategyclinical trial designdose selectionsafety assessmentendpoint strategydata interpretationregulatory submissionsclinical data analysisbiomarker data analysisproject leadership
Soft Skills
communication skillsinfluence skillsleadershipcross-functional collaborationrisk managementmentoringstrategic thinkingproblem-solvingrelationship buildingsynthesis of complex issues
Certifications
MDDO