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Senior Medical Director, Integrated Evidence Generation – Nephrology

Travere Therapeutics
2023 years ago
Remote friendly (United States)
United States
$233,000 - $315,000 USD yearly
Medical Affairs

Role Summary

The Sr. Medical Director, Integrated Evidence Generation – Nephrology will serve as the strategic architect of Travere’s Medical Affairs–led evidence infrastructure. This role defines and executes a multi-year integrated evidence strategy spanning post-approval interventional and non-interventional studies, investigator-sponsored research, collaborative research, real-world evidence, and lifecycle management. The role chairs the Evidence Generation Committee and acts as the senior medical authority on post-approval and lifecycle evidence, partnering cross-functionally to strengthen scientific credibility and long-term asset value. Location: San Diego, USA – Remote.

Responsibilities

  • Integrated Evidence & Lifecycle Strategy
    • Define and lead a 3–5-year integrated evidence roadmap aligned to lifecycle and access priorities
    • Serve as Medical Affairs evidence lead for lifecycle management planning and execution
    • Identify and address evidence gaps supporting label expansion, new subpopulations, combination strategies, durability, and long-term safety
    • Ensure evidence strategy strengthens regulatory positioning and lifecycle business cases
    • Partner with Clinical Development and Regulatory to align post-approval evidence with future development plans
  • Evidence Governance & Investment Oversight
    • Chair and govern the cross-functional Evidence Generation Committee
    • Establish clear prioritization criteria and portfolio governance processes
    • Oversee investment decisions across MA-led studies, ISR, collaborative research, and RWE
    • Ensure evidence investments are strategically aligned to lifecycle objectives
    • Provide executive-level updates to TA and GMA leadership
  • ISR & Collaborative Research Strategy
    • Establish and lead ISR governance framework within the TA
    • Define scientific prioritization aligned to strategic data gaps
    • Curate an ISR and collaborative research portfolio that advances guideline positioning, access strategy, and future development opportunities
    • Oversee partnerships with academic institutions, research networks, and Centers of Excellence
    • Monitor scientific impact and return on investment
  • Real-World Evidence (RWE) Leadership
    • Co-lead RWE strategy in partnership with Patient Access/HEOR
    • Align RWE initiatives with lifecycle, guideline, and access priorities
    • Identify and evaluate strategic data partnerships and registries
    • Ensure RWE outputs inform clinical practice insights, compendia engagement, and value demonstration
  • Build & Scale Medical Affairs–Led Research Capability
    • Establish and expand Travere’s Medical Affairs–led research capability
    • Develop scalable frameworks to support post-approval interventional, non-interventional, and implementation science studies
    • Identify opportunities where MA-led research complements Clinical Development and strengthens lifecycle strategy
    • Operationalize compliant, fit-for-purpose execution models appropriate for Travere
  • External Scientific Leadership & Therapeutic Area Partnership
    • Represent Travere in strategic society research initiatives and academic collaborations
    • Engage key opinion leaders, steering committees, and research consortia
    • Serve as internal authority on evolving evidence methodologies and standards
    • Contribute to cross-functional planning, advisory boards, and broader Medical Affairs priorities based on expertise and organizational needs
    • Collaborate with field medical teams to execute external expert interactions, evidence-generation activities, and training programs aligned with emerging evidence and medical strategies

Qualifications

  • Advanced scientific degree (MD, PharmD, PhD)
  • 8+ years of experience in Medical Affairs, clinical research, evidence generation, or other relevant experience
  • Deep expertise in interventional and non-interventional study design, RWE methodologies, ISR governance, post-approval and lifecycle evidence strategy
  • Experience contributing to or leading lifecycle management planning
  • Demonstrated ability to influence executive decision-making
  • Proven ability to operate in a lean, high-accountability biotech environment

Skills

  • Demonstrated ability to influence important customers, challenge common perceptions, and implement medical affairs tools to improve patient care and outcomes
  • Exemplary verbal and written communication skills, including formal presentation skills, and well-developed interpersonal skills
  • Strong organizational skills with the ability to prioritize and execute against key objectives and deliverables, on time and within budget
  • Demonstrates the highest ethical standards with strong knowledge of and adherence to applicable regulatory, legal, and compliance requirements
  • Highly adaptable and resourceful, with the ability to prioritize, manage complexity, and collaborate effectively in a fast-paced, cross-functional environment

Additional Requirements

  • Travel up to 40% (ASN, ERA-EDTA, NKF, KOL symposiums, etc.) and on-site presence in San Diego; some evenings and weekend availability may be required
  • On-site presence in San Diego; no role is expected to be 100% remote