Executive Medical Director, Clinical Development Nephrology

Travere Therapeutics•San Diego, CA

1d•$285,000 - $385,000•Remote

About The Position

We are seeking an experienced and strategic Executive Director, Clinical Development to lead the clinical development strategy for one or more programs in rare diseases. This leader will serve as the cross-functional project leader for assigned program(s), partnering closely with Research, Translational Medicine, Regulatory, Biometrics, Clinical Operations, Medical Affairs, Commercial, and Program Management. In this role, you will be accountable for shaping and executing development strategy from early clinical development through late-stage planning, with a strong focus on scientifically rigorous, patient-centered, and operationally feasible development plans in rare renal indications. Reporting to the SVP of Clinical Development & Clinical Pharmacology, you will play a visible leadership role across the organization and contribute meaningfully to portfolio and governance decisions in a collaborative environment.

Requirements

MD, DO, or equivalent medical degree required; advanced scientific training may be considered in combination with substantial relevant industry leadership experience.
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.
Ability to travel domestically and internationally (up to 20 to 25%)
All positions have an essential job function to be able to perform face to face work with colleagues and/or onsite in San Diego.
Driven, intelligent, passionate about making a difference for patients with rare diseases
Strong interpersonal and organizational skills and excellent verbal and written communication skills
Ability to work effectively in a multidisciplinary team to cultivate an inclusive environment of respectful, open, and honest dialogue and to foster a robust sharing of ideas and creative problem solving
Demonstrated ability to review, interpret and present complex scientific data
Well-organized with the ability to multi-task, prioritize, and manage shifting responsibilities in a dynamic, cross-functional teamwork environment
Excellent collaboration skills with strong attention to detail and the ability to manage complexity and challenges
Ability to adapt to modification and changes to project plans, demonstrating flexibility to implement new strategies and tactics to accommodate these changes

Nice To Haves

Direct experience in rare kidney diseases, including inherited, glomerular, complement-mediated, or other orphan renal disorders.
Experience with biomarkers, translational medicine, and precision medicine approaches relevant to renal disease.
Experience in global development and multinational clinical trials.
Prior people management experience is a plus, though not required for candidates with strong matrix leadership skills.
Familiarity with pediatric and adolescent development considerations in rare disease is desirable, depending on program scope.

Responsibilities

Clinical Development Leadership 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.
Program and Project Leadership 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.
Regulatory and External Leadership 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.
Cross-Functional and Organizational Leadership 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.