高级医学总监，临床开发
Senior Medical Director, 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、更持久的疗效和更简单的治疗体验，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：
风湿病临床开发高级总监将为针对风湿性适应症的创新疗法的临床开发策略和执行做出贡献。该职位将在我们的全球临床开发项目中担任关键临床贡献者，与跨职能团队合作，支持研究方案和监管活动的设计、规划和实施，以推进我们前沿抗体产品的开发。该人员将在风湿病临床开发团队中相对较早的阶段加入，并在指导研究和制定战略以推动项目成功方面发挥关键作用。
主要职责：
- 临床领导：为我们在风湿性适应症领域的前沿抗体产品组合的临床开发提供战略领导和医学专业知识。
- 试验管理：参与研究设计、执行和结果解读，重点关注概念验证及后续开发阶段。
- 跨职能协作：与统计、法规事务和临床运营等跨职能团队紧密合作，支持集成和战略性的试验执行。
- 法规事务：根据需要为 IND、研究者手册、临床研究报告、法规提交和回复以及其他项目文件提供科学/医学内容和其他输入。确保符合法规标准和指南，包括卫生主管部门对患者相关事项的医学专家签字要求。
- 安全监督：通过积极参与安全监测和数据审查流程，确保研究参与者的安全。
- 利益相关方沟通：在适当的情况下，代表临床开发部门与监管机构、研究者、关键意见领袖（KOL）和其他外部利益相关方进行互动。
- 其他所需工作。
理想候选人：
- 需要医学博士或同等医学学位。
- 至少 4 年以上在制药行业的临床开发经验。
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 Senior Director of Clinical Development for Rheumatology will contribute to the clinical development strategy and execution for innovative therapies targeting rheumatic indications. The Senior Director will play a pivotal role as a key clinical contributor within our global clinical development programs, partnering with cross-functional teams to support the design, planning, and implementation of study protocols and regulatory activities that advance the development of our cutting-edge antibody portfolio. This individual will join the Rheumatology Clinical Development team at a relatively early stage and will play a key role in directing research and formulating strategy to drive program success.
Key Responsibilities:
- Clinical Leadership: Contribute strategic leadership and medical expertise to the clinical development of our cutting-edge antibody portfolio in rheumatic indications.
- Trial Management: Contribute to the study design, execution and interpretation of results, with a focus on proof-of-concept and later phases of development.
- Cross-functional Collaboration: Work closely with cross-functional teams including Biostatistics, Regulatory Affairs, and Clinical Operations to support integrated and strategic trial execution.
- Regulatory: Provide scientific/medical content and other input as appropriate for INDs, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, and other program documents. Ensure compliance with regulatory standards and guidelines, including health authority requirements for MD sign-off on patient-related matters.
- Safety Oversight: Ensure the safety of study participants by actively participating in safety monitoring and data review processes.
- Stakeholder Engagement: Represent the Clinical Development function in interactions with regulatory agencies, investigators, KOLs, and other external stakeholders, as appropriate.
- Other activities as required.
Ideal Candidate:
- MD or equivalent medical degree is required.
- Minimum of 4+ years clinical development experience within the pharmaceutical or biotech industry within I&I indications, rheumatology strongly preferred.
- Experience with antibody therapeutics preferred.
- Proven track record in designing and executing clinical trials in immunology or inflammation.
- Experience with regulatory filings and interactions with health authorities.
- Strong understanding of GCP, clinical trial design, statistics, and global regulatory processes.
- Excellent communication and interpersonal skills, with the ability to motivate teams and collaborate effectively across functions.
- Ability to manage complex projects in a fast-paced 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 $343,000 to $365,000. 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