Role Summary
The Senior 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 (ISR), collaborative research, real-world evidence (RWE), and lifecycle management (LCM). 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 Travere’s scientific credibility and long-term asset value.
Responsibilities
- Define and lead a 3–5-year integrated evidence roadmap aligned to lifecycle and access priorities.
- Serve as Medical Affairs evidence leads for LCM 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.
- 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.
- 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.
- 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.
- 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.
- 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 may require some evenings and weekend availability.
- On-site work in San Diego; no role is 100% remote.