Vice President, Clinical Development

🕒 Março 18

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GondolaBio

SiteLinkedInTodas as Vagas

11 - 50 funcionários

Fundada em 2024

🧬 Biotecnologia

💊 Farmacêutico

💰 $300.000.000 Venture Round - GondolaBio em 2024-08

Biotechnology • Pharmaceuticals

A GondolaBio é uma empresa biofarmacêutica em estágio clínico lançada em 2024 e afiliada à BridgeBio Pharma, focada no desenvolvimento de terapias revolucionárias para pacientes com doenças genéticas. A empresa adota uma abordagem enxuta e descentralizada para acelerar a pesquisa e o desenvolvimento em estágio inicial através de múltiplas modalidades (incluindo pequenas moléculas e terapias com oligonucleotídeos) e está construindo um pipeline diversificado visando condições genéticas raras e pouco atendidas, como EPP/XLP, com seu programa principal PORT-77. A GondolaBio coloca as necessidades dos pacientes em primeiro lugar e busca levar tratamentos que modifiquem doenças de forma mais rápida para populações que não possuem terapias aprovadas.

Descrição

• 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

🎯 Requisitos

• 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

🏖️ Benefícios

• 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