Executive Director, Clinical Development

Department: 106750 Clinical Development Location: San Diego, USA- Remote Be a part of a global team that is inspired to make a difference in the lives of people living with rare disease. At Travere Therapeutics, we recognize that our exceptional employees are vital to our success. We are a dedicated team focused on meeting the unique needs of rare patients.Our work is rewarding - both professionally and personally - because we are making a difference. We are passionate about what we do. We are seeking talented individuals who will thrive in our collaborative, diverse, fast-paced environment and share in our mission - to identify, develop and deliver life-changing therapies to people living with rare disease. We stick by our values centered on patients, courage, community, and collaboration to pursue our vision of becoming a leading biopharmaceutical company dedicated to the delivery of innovation and hope to patients in the global rare disease community. At Travere Therapeutics, we are in rare for life. We continue to courageously forge new paths as we move toward a common goal of elevating science and service for rare patients. Position Summary: We are seeking an experienced and strategic Executive Director, Clinical Development to be a nephrology lead for one or more clinical trials in rare kidney diseases. This leader will partner 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 with a strong focus on scientifically rigorous, patient-centered, and operationally feasible development plans in rare renal indications. Reporting to the VP of Global Clinical Development, you will play a visible leadership role in a high profile program across the organization and contribute meaningfully to portfolio and governance decisions in a collaborative environment. Responsibilities: Clinical Development Leadership * Lead the overall clinical development strategy for assigned clinical trial(s) as a key contributor to indication strategy, target product profile, clinical positioning, and lifecycle planning. * Design and oversee clinical studies across phases, including protocol concept, eligibility criteria, endpoints, 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 lead nephrologist for assigned development program(s), driving cross-functional alignment on program goals, timelines, risks, decision points, and resource needs. * Lead clinical development discussions within program teams and represent Clinical Development at governance forums, presenting integrated assessments, strategic options, and recommendations for decision. 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. Regulatory and External Leadership * Important contributor to global regulatory strategy and represent Clinical Development in interactions with regulatory agencies, including FDA, EMA, and other heal th authorities. * Help prepare for... For full info follow application link. Travere Therapeutics, Inc. is an EEO/AA/Veteran/Disability Employer