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 health authorities.
- Help prepare for and participate in key regulatory meetings, including IND, 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 select 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 as needed.
- Work with Medical Affairs and Commercial colleagues to align development plans with future evidence-generation needs and patient/community insights.
- Additional duties assigned as needed.
Education/Experience Requirements:
- MD, DO, or equivalent medical degree required; advanced training in nephrology strongly preferred. Equivalent combination of education and applicable job experience may be considered.
- 10+ years of relevant experience in clinical research or drug development required, including at least 5 years in a leadership role responsible for clinical development strategy and major program decisions.
- Prior experience leading clinical programs in nephrology, rare disease, or closely related therapeutic areas strongly preferred.
- 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.
- 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.
Additional Skills/Experience:
- The ideal candidate will embody Travere’s core values: Courage, Community Spirit, Patient Focus and Teamwork.
- Driven, intelligent, passionate about making a difference for patients with rare diseases.
- 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.
- Familiarity with pediatric and adolescent development considerations in rare disease is desirable, depending on program scope.
- 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.
- 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. No role is expected to be 100% remote.
Total Rewards Offerings:
Travere provides comprehensive total rewards offerings that demonstrate our commitment as a diverse, equitable, people-centric, and pay-for-performance organization.
Benefits: Our benefits include premium health, financial, work-life and well-being offerings for eligible employees and dependents, wellness and employee support programs, life insurance, disability, retirement plans with employer match and generous paid time off.
Compensation: Our competitive compensation package includes a combination of both cash compensation (base pay and short-term incentive) and long-term incentive compensation (company stock), designed to recognize, retain, and reward employees.
Target Base Pay Range:
$246,000.00 - $332,000.00
*This information is current as of the date of this posting and may be modified in the future. Actual pay offered to a candidate will depend on a variety of factors including the candidate’s experience, education, skills, and location.
Travere will accept applications on an ongoing basis until a candidate is selected for the position.
Travere Therapeutics, Inc. is an EEO/AA/Veteran/Disability Employer.
If you require a reasonable accommodation to complete the application or interview process, please contact us by sending an email to accommodations@travere.com. Please note that this email address is to be used exclusively to request an accommodation with the online application, interview or hiring process only. Travere HR will not reply to emails sent to this address for any other reason.
