Vice President, Clinical Development

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Spyre Therapeutics

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11 - 50 employés

🏥 Santé

💼 Conseil

🏭 Fabrication

Healthcare • Consulting • Manufacturing

Spyre Therapeutics est une entreprise biopharmaceutique spécialisée dans le développement de thérapies pour la maladie inflammatoire de l'intestin (MII). L'entreprise s'engage à créer des anticorps de première classe, à proposer des combinaisons thérapeutiques raisonnées et à utiliser des approches d'immunologie de précision pour améliorer l'efficacité et la commodité des traitements pour les patients atteints de MII. Avec une équipe expérimentée dans le développement et la commercialisation de traitements pour diverses maladies, Spyre Therapeutics est dédiée à l'amélioration des options de traitement et des résultats pour les patients grâce à des recherches avancées en immunologie. L'entreprise favorise un environnement collaboratif et innovant pour atteindre sa mission de fournir de nouvelles options de traitement prometteuses pour la MII.

Description

• 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.

🎯 Exigences

• 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.

🏖️ Avantages

• 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.