临床开发副总裁
Vice President, Clinical Development
Spyre Therapeutics 是一家处于临床阶段的生物技术公司，致力于开发下一代疗法，通过提供更全面的疾病控制、更持久的疗效以及更简单的治疗体验，提升免疫学领域的治疗标准。Spyre 的产品管线包括针对 α4β7、TL1A 和 IL-23 的研究性长效抗体。
职位概述：
临床开发副总裁（免疫学与炎症方向），向 IBD 临床开发副总裁汇报，将为 Spyre 针对 IBD 的抗体药物临床组合提供战略和运营领导。该职位专为在高增长生物科技环境中茁壮成长并擅长平衡长期临床开发战略与实际执行的医生领导者而设计。成功候选人将亲自领导正在进行的 II 期平台试验，并参与塑造未来的注册试验计划。
主要职责：
- 临床领导：
- 为我们在 IBD 领域的前沿抗体组合的临床开发提供战略领导和医学专业知识。
- 制定并持续优化与公司目标、竞争格局和不断演变的科学见解一致的整合临床开发计划。
- 作为一线试验负责人负责当前平台试验，并参与关键试验的规划。
- 亲自参与方案制定、医学审查、安全性评估、数据解读以及正在进行和未来 IBD 临床试验的决策。
- 支持医学监测团队的工作，确保及时回应研究站点，提供医学安全监督，并支持收集高质量、临床稳健的数据。
- 项目策略与试验执行：
- 为所有开发阶段的临床研究的设计、实施、分析和解读提供医学和科学领导。
- 领导方案制定、试验实施、数据审查和解读，与临床运营、监管、统计等密切合作，确保成功执行。
- 通过分析新兴的临床、转化、安全和竞争数据，推动关键开发决策。
- 主持或参与治理委员会和跨职能项目团队。
- 跨部门协作：
- 与监管事务、生物制药、临床运营等部门紧密合作，确保项目顺利推进。
查看英文原文
Spyre Therapeutics is a clinical-stage biotechnology company committed to developing next-generation therapies that elevate the standard in immunology by delivering more complete disease control, greater durability, and a simpler treatment experience for patients. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23.
Role Summary:
The Vice President, Clinical Development (Immunology & Inflammation), reporting to the SVP of IBD Clinical Development, will provide strategic and operational leadership across Spyre's clinical portfolio of antibody therapeutics for IBD. This role is uniquely designed for a physician leader who thrives in a high-growth biotechnology environment and enjoys balancing long-term clinical development strategy with hands-on execution. The successful candidate will personally lead the ongoing Phase 2 platform study while helping to shape the future registrational program.
Key Responsibilities:
- Clinical Leadership:
- 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.
- Program Strategy & Trial Execution:
- 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.
- Cross-functional Collaboration:
- 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.
- Regulatory Interface:
- 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.
- Safety Oversight:
- 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.
- Leadership & Mentorship:
- Lead and mentor a high-performing clinical development team as the company grows.
- Contribute broadly to corporate strategy, organizational planning, and leadership initiatives.
- Other duties as assigned.
Ideal Candidate:
- 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.
What We Offer:
- 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.
The expected salary range offer for this role is $366,000 to $398,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.
As an equal opportunity employer, Spyre is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment designed to create a stronger and better Spyre that is focused on developing life-changing products for patients.
Spyre Therapeutics, along with other biotech companies, has become aware of a surge in email scams targeting prospective job candidates within our industry. Please be aware that official recruiters at Spyre Therapeutics only use email addresses with the domain “@spyre.com.” We want to also emphasize that we never request candidates to make any purchases or divulge sensitive personal information via email.
Please also be aware that all job postings will be listed on our website at spyre.com/careers/.
Originally posted on Himalayas