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