Vice President – Clinical Development

Role Overview

• 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

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 preferred

Benefits

• premium health
• financial offerings
• work-life and well-being offerings for eligible employees and dependents
• wellness and employee support programs
• life insurance
• disability
• retirement plans with employer match
• generous paid time off