Vice President, Clinical Development

🕒 Julho 21

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $366.000 - $398.000 / ano

⏰ Tempo Integral

🔴 Especialista

👔 Vice-presidente

👻 Score fantasma 36%

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Spyre Therapeutics

SiteLinkedInTodas as Vagas

11 - 50 funcionários

🏥 Saúde

💼 Consultoria

🏭 Manufatura

Healthcare • Consulting • Manufacturing

A Spyre Therapeutics é uma empresa biofarmacêutica focada no desenvolvimento de terapias para Doenças Inflamatórias Intestinais (DII). A empresa está comprometida em criar anticorpos de melhor classe, combinações terapêuticas racionais e em empregar abordagens de imunologia de precisão para aumentar a eficácia e conveniência do tratamento para pacientes com DII. Com uma equipe experiente em desenvolver e comercializar tratamentos para várias doenças, a Spyre Therapeutics é dedicada a melhorar as opções de tratamento e os resultados para os pacientes por meio de pesquisas avançadas em imunologia. A empresa promove um ambiente colaborativo e inovador para alcançar sua missão de fornecer novas opções de tratamento promissoras para DII.

Descrição

• Provide strategic leadership and medical expertise for the clinical development of our cutting-edge antibody portfolio in IBD. • Develop and continuously refine integrated clinical development plans aligned with corporate objectives, competitive landscape, and evolving scientific insights. • Serve as a hands-on study lead for the current platform trial as well as contribute to planning pivotal studies. • Personally contribute to protocol development, medical review, safety assessment, data interpretation, and study-level decision making for ongoing and future IBD clinical trials. • Support the efforts of the medical monitoring team which ensures timely responses to investigative sites, provides medical safety oversight, and supports the collection of high-quality, clinically robust data. • Provide medical and scientific leadership for the design, conduct, analysis, and interpretation of clinical studies across all phases of development. • Lead protocol development, study conduct, data review, and interpretation for ongoing clinical trials, partnering closely with clinical operations, regulatory, biometrics, etc., to ensure successful execution. • Drive key development decisions through analysis of emerging clinical, translational, safety, and competitive data. • Chair or contribute to governance committees and cross-functional program teams. • Partner closely with Regulatory Affairs, Biostatistics, Clinical Operations, Translational Sciences, Medical Affairs, CMC, Commercial, and Corporate Development teams to ensure coordinated execution of development strategies. • Promote a culture of scientific excellence, accountability, and collaboration. • Lead clinical and medical strategy for regulatory interactions globally. • Serve as a primary medical representative for regulatory submissions, including INDs, CTAs, briefing packages, BLAs, NDAs, and related responses. • Ensure development programs are conducted in compliance with global regulatory requirements and industry best practices. • Provide ongoing medical oversight of participant safety and benefit-risk assessments across assigned programs. • Review and interpret emerging safety data and contribute to safety governance activities, including Data Monitoring Committees and internal safety review forums. • Support signal detection, risk management planning, and clinical risk mitigation strategies. • Lead and mentor a high-performing clinical development team as the company grows. • Contribute broadly to corporate strategy, organizational planning, and leadership initiatives.

🎯 Requisitos

• MD or equivalent medical degree is required. • Minimum of 7+ years clinical development experience within the pharmaceutical or biotech industry, including substantial leadership experience in immunology, inflammation, or gastroenterology. • Training and/or experience in clinical development in gastroenterology or immunology & inflammation is strongly preferred. • Demonstrated success leading mid- and late-stage clinical development programs. • Experience developing antibody therapeutics. • Experience leading complex, adaptive, umbrella, basket, or platform clinical trials is highly desirable. • Deep expertise in inflammatory bowel disease and/or other immune-mediated inflammatory disorders strongly preferred. • Significant experience with global regulatory interactions and submissions, including INDs, CTAs, briefing documents for global regulatory agencies. • Strong understanding of clinical trial design, biostatistics, translational medicine, drug development, and global regulatory requirements. • Demonstrated ability to influence strategy and drive cross-functional decision-making in a matrixed environment. • Demonstrated willingness and ability to remain personally engaged in study-level execution while simultaneously providing strategic leadership. • Strategic, entrepreneurial leader with the ability to balance long-term vision and hands-on execution in a fast-paced biotech environment.

🏖️ Benefícios

• Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly. • Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits. • Unlimited PTO • Two, one-week company-wide shutdowns each • Commitment to provide professional development opportunities. • Remote working environment with frequent in-person meetings to address complex problems and build relationships.