Vice President, Clinical Development

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GondolaBio

Site WebLinkedInTous les Emplois

11 - 50 employés

Fondée en 2024

🧬 Biotechnologie

💊 Pharmaceutique

💰 €300 000 000 Venture Round - GondolaBio en 2024-08

Biotechnology • Pharmaceuticals

GondolaBio est une entreprise biopharmaceutique en phase clinique, lancée en 2024 et affiliée à BridgeBio Pharma, concentrée sur le développement de traitements révolutionnaires pour les patients atteints de maladies génétiques. La société utilise une approche allégée et décentralisée pour accélérer la recherche et le développement en phase initiale à travers de multiples modalités (y compris les petites molécules et les thérapies à base d'oligonucléotides) et construit un pipeline diversifié ciblant des affections génétiques rares et négligées telles que l'EPP/XLP avec son programme principal PORT-77. GondolaBio place les besoins des patients au centre de ses préoccupations et vise à apporter plus rapidement des traitements modificateurs de maladies à des populations dépourvues de thérapies approuvées.

Description

• 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

🎯 Exigences

• 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 • Recent experience of IND and NDA/BLA submissions strongly preferred • 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

🏖️ Avantages

• Patient Days, where we are fortunate enough to learn more about the lives we are looking to impact and a real exchange of ideas as to how we can improve our efforts • A culture inspired by our values: put patients first; think independently; be radically transparent; every minute counts; and let the science speak • Collaborative business environment • Excellent compensation package (Base, Performance Bonus, Equity) • Excellent benefits package • Flexible PTO • A fast-paced, data-driven, work environment with world-class R&D minds and capabilities • Work with the most productive groups of R&D operators in the industry • A platform for meaningful scientific contributions to shine