GondolaBio · 16 hours ago
Vice President, Clinical Development
United States
Full-time
Remote
Director/Executive
$288K/yr - $380K/yr
10+ years expGondolaBio is a collection of biopharmaceutical companies focused on developing next-generation therapeutics for genetic diseases. They are seeking a top clinical development executive to build and execute the clinical development plan for their lead program, primarily accountable for clinical trial execution, study design, and management.
BiotechnologyManufacturingPharmaceutical
Responsibilities
Design scientifically rigorous, innovative, and cost-effective clinical development programs, integrating preclinical, translational, and biomarker strategies
Direct and oversee the efficient implementation of all clinical projects, including defining initial clinical endpoints, dose-escalation strategies, and patient selection approaches
Lead development and contribute to review of Clinical Study Protocols, Clinical Study Reports, Investigator’s Brochures, and all clinical documentation for regulatory filings
Become an internal expert on all medical features of the disease area, including natural history, patient diagnostic journey, standards of care, and current development programs
Build, mentor, and scale the clinical development and clinical operations teams, including defining structure, capabilities, and external partnerships appropriate for each stage of the program
Provide leadership and clinical development expertise to the overall organization, including the clinical development, clinical operations, biometrics, toxicology, and translational science teams
Collaborate with Regulatory Affairs to develop strategies and tactical work plans during clinical development and in preparation for the anticipated US and global filings
Lead the preparation and management of clinical information to support timely regulatory submissions, including INDs, briefing documents, and early clinical protocols
Set a high standard and example of urgency, work quality, and effectiveness
Contribute to due diligence and gap analysis on potential new GondolaBio assets
Partner closely with discovery and preclinical teams to ensure clinical readiness for first-in-human studies
Perform all other duties as assigned
Qualification
Required
Doctorate Degree in Medicine (MD) is required for the position
A proven leader with minimum of 10 years pharmaceutical/biotechnology industry experience in all phases of drug development
Deep knowledge of the drug development process with a focus on clinical study design and management; ability to collaborate with, support, and oversee CROs
Able to drive strategic thinking and plans for successful clinical trial outcomes
Experience interfacing with the global regulatory authorities (incl. FDA, EMA) and respective standards, including hands-on experience in global drug development
Dynamic individual with excellent written, communication, and interpersonal skills
Ability to deliver effective presentations both internally and externally, and strong networking abilities and creativity
Ability to set priorities, work independently and deliver high-quality results with urgency
Vital planning, organizational, and leadership skills
Results-oriented. Strong initiative, accountability, and willingness to take ownership and drive projects to completion
Experience in driving collaborations and working with external partners, including building networks with key opinion leaders (KOL) and investigators, business partners
Proven ability to build, mentor, and scale clinical development teams over time
Able to proactively identify and solve problems under pressure
Motivated to work in a fast-paced, highly accountable, small company environment. A 'can do' and collegial professional who leads through influence and interpersonal skills. Demonstrated matrix leadership skills and ability to collaborate successfully with multiple functions and external vendors in a cross-functional team environment
Solid critical, strategic, and analytical thinking skills
Travel required
Preferred
Recent experience of IND and NDA/BLA submissions strongly preferred
Benefits
Excellent compensation package (Base, Performance Bonus, Equity)
Excellent benefits package
Flexible PTO
Company
GondolaBio
GondolaBio researches, develops and manufactures pharmaceutical products. It is a sub-organization of BridgeBio.
11-50 employees
Funding
Current Stage
Early StageTotal Funding
$300M2024-08-16Series Unknown· $300M
Leadership Team
J
James Li
President
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