Executive Medical Director, Nephrology Clinical Development

 diverse, and fast-paced environment and share our commitment to identifying, developing, and delivering life-changing therapies for individuals with rare diseases. Our core values of patient focus, courage, community, and collaboration drive our vision to be a leading biopharmaceutical company committed to innovation and hope for patients worldwide.

Position Summary:

We are looking for an experienced and strategic Executive Medical Director to lead clinical development strategies in rare diseases. In this vital role, you will serve as the cross-functional project leader for clinical programs, collaborating closely with Research, Translational Medicine, Regulatory, Biometrics, Clinical Operations, Medical Affairs, Commercial, and Program Management teams.

In this role, you will shape and execute development strategies from the early stages through late-stage planning, with a strong emphasis on scientifically rigorous, patient-centered, and operationally feasible plans for rare renal indications. Reporting to the Senior Vice President of Clinical Development & Clinical Pharmacology, you will play a crucial leadership role across the organization, contributing to portfolio and governance decisions in a collaborative environment.

Key Responsibilities:
• Clinical Development Leadership
• Lead the overall clinical development strategy for assigned programs, including indication strategy, target product profile, clinical positioning, and lifecycle planning.
• Serve as the project lead, integrating insights from nonclinical research, biomarker development, safety regulations, and competitive analysis into development plans.
• Design and oversee clinical studies across phases, including protocol concepts, eligibility criteria, endpoints, safety monitoring, dose selection, and statistical considerations.
• Provide leadership for study conduct, including protocol deviation reviews and data interpretation.
• Lead the analysis and interpretation of clinical data and contribute to the creation of key documents including protocols, Investigator's Brochures, Clinical Study Reports, abstracts, manuscripts, and health authority briefing materials.
• Partner with Biometrics to establish strategies for meaningful analysis and interpretation of efficacy, safety, pharmacokinetic/pharmacodynamic, and biomarker data.
• Program and Project Leadership
• Act as the project leader for development programs, driving cross-functional alignment on goals, timelines, risks, decision points, and resource needs.
• Lead core team meetings and represent the program at governance forums, providing clear recommendations based on data and strategic fit.
• Collaborate on integrated development plans with cross-functional partners to assure disciplined execution against milestones.
• Identify early program risks and develop comprehensive mitigation strategies covering clinical, regulatory, operational, and portfolio aspects.
• Facilitate scenario planning and decision analyses to support critical stage-gate and investment decisions.
• Regulatory and External Leadership
• Contribute to global regulatory strategies and represent Clinical Development in interactions with regulatory bodies including the FDA and EMA.
• Prepare for and participate in key regulatory meetings, such as end-of-Phase 2 interactions.
• Establish and maintain relationships with academic experts, investigators, patient advocacy groups, and other external stakeholders within the nephrology and rare disease domains.
• Support due diligence and business development initiatives, including assessments of external assets in nephrology or related rare disease areas.
• Cross-Functional and Organizational Leadership
• Collaborate with Clinical Operations to ensure study designs are executable and enrollment strategies are realistic for rare disease settings.
• Work with Non-Clinical teams to incorporate mechanistic and disease-relevant endpoints into development pathways.
• Engage with Clinical Pharmacology, Pharmacovigilance, CMC, Health Economics and Outcomes Research, Medical Writing, and other project functional leads.
• Partner with Medical Affairs and Commercial teams to align development plans with future evidence-generation needs and patient insights.
• Mentor junior project team members and contribute to building a high-performing clinical development workforce.
• Exemplify strong enterprise leadership, balancing program advocacy with overall portfolio strategy.

Education & Experience Requirements:
• MD, DO, or equivalent medical degree required; advanced scientific training is a plus when combined with substantial relevant industry experience.
• 10+ years of experience in biotech and/or pharmaceutical clinical development with progressive leadership roles.
• Prior experience in leading clinical programs in nephrology, rare diseases, or closely related fields is strongly preferred.
• Demonstrated program or project leadership in a cross-functional drug development environment.
• Strong understanding of clinical trial design, safety assessments, endpoint strategy, and interpretation of complex clinical datasets.
• Experience with regulatory submissions and health authority interactions.
• Proven history of leading development strategy through key milestones like IND submission, proof-of-concept, end-of-Phase 2, and registrational planning.
• In-depth knowledge of the unique challenges in rare disease development including small populations, site selection, natural history studies, endpoint selection, and patient engagement.
• Excellent communication and influencing skills, with a strong ability to synthesize complex subjects for senior leaders and governance groups.

Preferred Experience:
• Direct experience with rare kidney diseases, including inherited, glomerular, complement-mediated, or other orphan renal disorders.
• Familiarity with biomarkers, translational research, and precision medicine approaches relevant to renal disease.
• Experience in global development and conducting multinational clinical trials.
• Prior experience in people management is a plus, although strong matrix leadership skills can be equally valuable.
• Awareness of pediatric and adolescent development considerations in rare diseases is desirable, depending on the scope of the programs.

Additional Skills/Requirements:
• The ideal candidate will align with Travere's core values: Courage, Community Spirit, Patient Focus, and Teamwork.
• A driven, intelligent, and passionate approach to making a difference for patients with rare diseases.
• Strong interpersonal and organizational abilities, alongside excellent verbal and written communication skills.
• Adept at working effectively in a multidisciplinary team to cultivate an inclusive environment of honest dialogue and collaborative problem-solving.
• Demonstrated capability to review, interpret, and present complex scientific data.
• Highly organized with the capability to juggle multiple priorities and adapt in a dynamic, cross-functional teamwork environment.
• Exceptional collaboration skills with keen attention to detail, adept at managing complexity and challenges.
• Flexibility in adapting to changes in project plans, showcasing the ability to implement new strategies as required.
• Willingness to travel domestically and internationally (up to 20-25%).
• This position will require face-to-face interaction with colleagues and/or onsite work in San Diego; no role is expected to be 100% remote.

Travere is an EEO/AA/Veteran/Disability Employer

Total Rewards Offerings:

Travere provides a comprehensive total rewards package highlighting our commitment to diversity, equity, and a people-centric culture.

Benefits: Our benefits encompass premium health, financial, work-life balance, and well-being offerings for eligible employees and their families, along with wellness support programs, life insurance, disability benefits, retirement plans with employer matches, and generous paid time off.

Compensation: Our competitive compensation package includes both cash compensation (base salary and short-term incentives) and long-term incentives (company stock) to acknowledge, retain, and reward employees.

Target Base Pay Range:

$285,000.00 - $385,000.00
• This information is current as of the date of this posting and may change in the future. Actual pay offered will depend on various factors including the candidate's experience, education, skills, and location.

Travere is accepting applications continually until a suitable candidate is found.

Travere Therapeutics, Inc. is an EEO/AA/Veteran/Disability Employer.

If you require a reasonable accommodation to complete the application or interview process, please reach out via email to [email protected] exclusively for that purpose. Please note that this address is strictly for requesting accommodations related to the application, interview, or hiring process.