Executive Medical Director, Clinical Development

Department :

106750 Clinical Dev - Non-Renal

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 :

The Executive Medical Director, Clinical Development (non-renal) is responsible for providing overall clinical and scientific oversight and leadership for Travere's rare metabolic development programs and clinical research projects across Phases 1-4. This will include an exciting, high-visibility, Phase 3 program in a rare metabolic disease and may include other therapeutic areas as the company expands its pipeline. This position will report to the SVP, Clinical Development and Clinical Pharmacology.

This experienced clinical leader will work collaboratively with all functions including the being a member of development Program Strategy Team (PST) with the purpose to develop and deliver a clinical development strategy tailored to the disease that is efficient and of high scientific quality.

Additional responsibilities include developing relationships with leading key opinion leaders, acting as subject matter expert for additional programs, provide medical support as needed for clinical trials, marketed products, pharmacovigilance, and provide medical / scientific expertise as needed for business development efforts.

Responsibilities :

• Clinical development lead for assigned development programs as part of the Program Strategy Team (PST) and represents the program to executive leadership and study team members.
• Responsible for leading the development of protocols and clinical / scientific strategy across Phase 1-4.
• Understanding of the development and regulatory strategy (from pre-IND to NDA / BLA) and devices (Human Factor studies) to provide clinical and scientific insights as part of the PST.
• Understanding and knowledge of the rare metabolic and genetic disease areas as well as the future landscape and treatment paradigm in order to provide strategic input into future development needs, biometrics analyses, publications, and core presentations.
• Partners with Biometrics to plan data entry, analysis and interprets in collaboration with biostatistics the data results for the PST and Medical Affairs colleagues.
• Supports the recruitment / screening / selection of competent investigators in collaboration with Clinical Operations; assures that Good Clinical Practices (GCPs) are followed; assures timely completion of studies; monitors data for safety and efficacy trends by reviewing clinical data; and authors clinical reports upon completion or termination of studies (in cooperation with statistical staff / consultants).
• Accountable for preparing clinical portions of protocols, investigator brochures, medical reports, efficacy and safety summaries, scientific rationales, and benefit / risk ratios.
• Lead and mentor Clinical Development staff, consultants, and vendor medical monitor to foster a high-performance culture within the Clinical Development department.
• Proactively establishes and maintains relationships with stakeholders i.e., alliance partners, external companies, investigators, and key opinion leaders.
• Plays a key leadership role in Health Authority interactions and development of regulatory documents.
• Attend and present at investigator meetings and site initiation visits as applicable.
• Works cross-functionally with medical affairs and prepares manuscripts, posters, and other scientific communications and conducts presentations at scientific meetings.
• Understanding of governance and ability to represent the programs and key decisions at cross-functional governance meetings.

Education / Experience Requirements :

Additional Skills / Experience / Requirements :

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 :

285,000.00 - $385,000.00

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.

Salary : $285,000 - $385,000