at Travere Therapeutics in WichitaWichita, Kansas, United States
Job Description
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:
The Vice President, Clinical Development (Nephrology) will be the project co-lead responsible for overall clinical, scientific, and strategic oversight for Travere's Rare Kidney Disease development programs and clinical research projects across Phases 1-4. This person should be a seasoned leader who can drive programs, key deliverables and execute cross-functionally in a matrix organization. This position will report to the SVP, Clinical Development and Drug Safety/Pharmacovigilance.
This accomplished and experienced clinical leader will work collaboratively with all functions as the Global Development Physician Lead on the Program Strategy Teams (PST) to develop and deliver a clinical development strategy tailored RKD programs, which are efficient and of high scientific quality. Additional responsibilities include developing relationships with leading key opinion leaders, acting as subject matter expert for additional programs, providing medical support as needed for clinical trials, marketed products, pharmacovigilance, as well as providing medical/scientific expertise as needed for business development efforts.
Responsibilities:
Global Development Physician 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 effectively communicating program goals, strategies, plans, issues and risks with team members, department heads, review boards, and the executive team
Deep understanding of working with cross-functional team members to create clinical development plans, timelines, risk tradeoffs including regular engagement/presentations with regulatory agencies is critical
Responsible for leading the development of protocols and clinical/scientific strategy for 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 interpretation for the PST and Medical Affairs colleagues
Accountable for clinical portions of protocols, investigator brochures, medical reports, efficacy and safety summaries, scientific rationales, and benefit/risk ratios
Lead and mentor Clinical Development staff and consultants 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
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:
M.D. or M.D./Ph.D. degree required; nephrology training and rare kidney disease drug development experience strongly preferred
12+ years of experience in clinical research including the design and execution of clinical trials within a pharmaceutical or biotech environment; 8+ years leadership experience
Demonstrated ability to lead cross-functional teams in a matrix environment
NDA/BLA submissions experience... For full info follow application link.
Travere Therapeutics, Inc. is an EEO/AA/Veteran/Disability Employer
