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 (non-renal) will be the project co-lead responsible for overall clinical, scientific, and strategic oversight 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 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 Clinical Pharmacology.
This accomplished and experienced clinical leader will work collaboratively with all functions including co-leading the development Program Strategy Team (PST) 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, 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:
Co-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, 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
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
Additional duties assigned as needed
Education/Experience Requirements:
M.D. or M.D./Ph.D. degree or equivalent required. Equivalent combination of education and applicable job experience may be considered
12+ years of experience in clinical research including the design and execution of clinical trials, preferably within a pharmaceutical or biotech environment although time spent in relevant high caliber academic clinical research will be counted towards the total; 8+ years leadership experience
Demonstrated ability to lead cross-functional teams in a matrix environment
Metabolics/genetics and/or rare disease experience and NDA/BLA submissions is strongly preferred
Additional Skills/Experience/Requirements:
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
Strong interpersonal and organizational skills and excellent verbal and written communication skills
Experiences with devices and human factors studies preferred
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... For full info follow application link.
Travere Therapeutics, Inc. is an EEO/AA/Veteran/Disability Employer
