Department:
106750 Clinical Dev - Non-Renal
Location:
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 of Clinical Development, as a strategic partner to the Chief Medical Officer, will provide strategic planning and execution of the rare nephrology and metabolic programs and will oversee the cross-functional Project Strategy Teams comprised of Clinical Development, Clinical Operations, Regulatory, CMC, Med Affairs, Commercial and Project Management. This position will be responsible for establishing and executing the global strategy for the development, approval and commercialization across Travere's pipeline and potential new programs. This person is expected to have a wide range of clinical development leadership and expertise in nephrology and rare disease for due diligence and clinical development strategy across the lifecycle of therapeutics from pre-IND to commercialization as well as small molecule to biologics. This person should be a seasoned leader who can drive programs, key deliverables and execute cross-functionally in a matrix organization.
Responsibilities:
- Provide clinical leadership, guidance and strategy to Travere's programs. Manage the overall clinical development for Travere's programs, ensuring that clinical and regulatory milestones are met.
- Guide the team through the development and/or update of the global strategic plan that lays out a pathway for successful development and commercial approval.
- Have a deep understanding and knowledge of Travere's core disease areas (rare nephrology + metabolic) 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.
- Provide scientific oversight, foster debate and solicit expert input (internal and external) on important development choices; lay out alternatives, analyze key risks and implications of choices, and drive team to agreement on strategic, development, regulatory & operational recommendations.
- Responsible for effectively communicating program goals, strategies, plans, issues and risks with team members, department heads, review boards, the executive team and the board of directors.
- Regulatory strategy and FDA engagement is a key component of this role and deep understanding of creating clinical development plans, timelines, risk tradeoffs including regular engagement/presentations with regulatory agencies is critical.
- Directly responsible for managing clinical development (renal and metabolic) including managing and mentoring and leading clin dev physicians, clinical scientists and clinical pharmacology.
- Work with the team to develop aggressive but realistic Project Team goals, plans, timelines and budgets and with oversight of the program execution.
- Ensure appropriate communications channels are maintained and reporting schedules adhered to.
- Strategic engagement across multiple department heads including biometrics, regulatory, clinical operations, and medical affairs to ensure dissemination of information and strategic alignment across programs.
- Cross collaboration with therapeutic leaders in medical affairs to contribute scientifically to publication strategy, congress planning, scientific communication and messaging, and KOL engagement.
- Cross collaboration with pharmacovigilance on ensuring a holistic approach to monitoring, safety and etc.
- Develop and negotiate select budgets, timelines and other expectations in order to establish clear expectations. Accountable for financial oversight of the project/program with the project team leader.
- Considered a leader in clinical development and is able to present plans and strategies holistically at scientific congresses, with KOLs, and with regulatory agencies.
- Understanding of governance and ability to represent the programs and key decisions at cross-functional governance meetings.
- A key leader as part of the Enterprise Leadership Team with a focus on corporate mission and vision.
- The ideal candidate will embody Travere's core values: Courage, Community Spirit, Patient Focus and Teamwork.
Education/Experience Requirements:
- MD (nephrologist preferred) in a drug development-related discipline with 11+ years of experience in the pharmaceutical or biotechnology industry, with direct experience in drug development and 5+ years of leadership experience. The ideal candidate would have had multiple experiences on programs in various stages of development, including pre-IND, Phase 1-4 and NDA/BLA submissions. Equivalent combination of education and applicable job experience may be considered.
- Proven ability to manage strategic clinical development for a product from pre-clinical through all clinical phases and product launch.
- Excellent interpersonal, negotiation, influencing and communication skills with ability to relate to both internal and external stakeholders. Experience presenting to a wide variety of audiences including internal teams, medical, regulatory, patient and scientific communities.
- Experience leading and/or managing cross-functional drug development teams and/or functional subteams.
- Experience developing, implementing and leading a broad range of clinical trials, both in the U.S. and ex-U.S., including SOPs.
- Experience building and managing collaborations with scientists, contract research organizations (CROs), consultants, pharmaceutical partners and other outside organizations.
- Excellent working knowledge of FDA & ICH/GCP regulations and guidelines.
- Ability to work in a team environment, meet deadlines and prioritize and balance work from multiple individuals.
- Experience in effective and constructive communication, coordination and cooperation with all levels in a matrix organization, including senior management.
- Ability to travel up to 20%, domestically and internationally.
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: $305,000.00 - $390,000.00
*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.
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.
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