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Travere Therapeutics · 1 week ago

Vice President, Clinical Development (Rare Metabolic Disease)

San Diego, CA

Full-time

Hybrid

Director/Executive

$305K/yr - $410K/yr

12+ years exp

Travere Therapeutics is a biopharmaceutical company dedicated to delivering innovative therapies for rare diseases. The Vice President of Clinical Development will oversee clinical and strategic initiatives for rare metabolic disease programs, collaborating with cross-functional teams to ensure high-quality clinical development strategies and execution.

BiotechnologyHealth CareMedical

Comp. & Benefits

H1B Sponsor Likely

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

Qualification

Clinical Development StrategyClinical Trial DesignRare Disease ExpertiseLeadership ExperienceRegulatory StrategyCross-Functional Team LeadershipInterpersonal SkillsCommunication SkillsOrganizational SkillsProblem SolvingCollaboration Skills

Required

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