临床开发执行总监
Executive Director, Clinical Development
Mineralys Therapeutics 是一家处于临床阶段的生物制药公司，专注于开发针对高血压及相关合并症（如慢性肾病（CKD）、阻塞性睡眠呼吸暂停（OSA）和其他由醛固酮失调驱动的疾病）的药物。其首个候选药物 lorundrostat 是一种专有、口服、高度选择性的醛固酮合成酶抑制剂。Mineralys 总部位于宾夕法尼亚州 Radnor。更多信息，请访问 https://mineralystx.com。关注 Mineralys 的 LinkedIn、Twitter 和 Bluesky。
Mineralys 是一家完全远程办公的公司。
临床开发执行总监
临床开发执行总监将作为开发项目组的临床负责人，发挥关键作用，推动关键研究、监管策略和提交准备。该医学负责人将在项目生命周期内提供医学和科学监督，从方案设计和研究实施到数据解读、监管互动和上市准备。
此职位需要一位亲力亲为的临床开发领导者，能够在快节奏的生物科技环境中工作，并能跨职能合作，以紧迫性推动高质量执行。
主要职责：
临床开发领导
- 作为一个或多个临床项目的临床负责人，负责临床试验设计、执行监督和关键里程碑的交付。
- 领导临床计划、方案、修正案及相关研究文件的制定。
- 对 II/III 期和/或注册研究提供医学监督，确保患者安全、数据完整性和运营卓越。
- 与临床运营、统计学、数据管理、监管和安全团队合作，确保研究高效执行和及时解决问题。
- 推动研究启动、入组、中期分析、数据库锁定、主要结果和 CSR 提交。
医学监测 / 安全监督
- 作为指定研究的医学监查员，包括审查入选资格、方案偏离、安全信号、严重不良事件/不良事件（SAEs/AEs）和获益-风险评估。
- 与药物警戒部门合作进行安全监测、信号检测、DSMB 材料和汇总安全报告。
- 支持风险缓解策略的制定，并确保在整个项目执行过程中患者安全始终是核心。
监管 / 提交支持
- 参与全球监管事务
查看英文原文
“Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone. Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor. Mineralys is headquartered in Radnor, Pennsylvania. For more information, please visit https://mineralystx.com. Follow Mineralys on LinkedIn, Twitter and Bluesky”
Mineralys is a fully remote company.
Executive Director, Clinical Development
The Executive Director, Clinical Development will serve as the clinical lead for development program(s) and play a critical role in advancing pivotal studies, regulatory strategy, and submission readiness. This physician leader will provide medical and scientific oversight across the program lifecycle, from protocol design and study execution through data interpretation, regulatory interactions, and launch preparation.
This role requires a hands-on clinical development leader who thrives in a fast-paced biotech environment and can partner cross-functionally to drive high-quality execution with urgency.
Key Responsibilities:
Clinical Development Leadership
- Serve as the clinical lead for one or more clinical programs, with responsibility for clinical trial design, execution oversight, and delivery of key milestones.
- Lead development of clinical plans, protocols, amendments, , and related study documents.
- Provide medical oversight for Phase 2/3 and/or registrational studies, ensuring patient safety, data integrity, and operational excellence.
- Partner with Clinical Operations, Biostatistics, Data Management, Regulatory, and Safety to ensure efficient study execution and timely issue resolution.
- Drive study start-up, enrollment, interim analyses, database locks, topline results, and CSR delivery.
Medical Monitoring / Safety Oversight
- Serve as medical monitor for assigned studies, including review of eligibility, protocol deviations, safety signals, SAEs/AEs, and benefit-risk assessments.
- Collaborate with Pharmacovigilance on safety surveillance, signal detection, DSMB materials, and aggregate safety reporting.
- Support development of risk mitigation strategies and ensure patient safety remains central throughout program execution.
Regulatory / Submission Support
- Contribute to global regulatory strategy and interactions with health authorities (FDA, EMA, PMDA, etc.).
- Author and review clinical sections of regulatory documents, including briefing books, protocols, CSRs, IBs, and submission modules.
- Present clinical data and strategy to regulators, internal governance committees, and senior leadership.
Scientific / Cross-Functional Leadership
- Serve as the key clinical voice on cross-functional program teams.
- Partner with Translational Medicine, Biomarkers, Medical Affairs and Commercial to align development strategy with future launch needs.
- Support publication planning, congress presentations, and external scientific engagement.
- Build strong relationships with KOLs, investigators, and external experts.
Team / Culture Leadership
- Mentor internal team members and external consultants/CRO partners.
- Foster a culture of collaboration, accountability, urgency, and quality.
- Operate effectively in a lean biotech environment where flexibility and ownership are essential.
Experience and Qualifications:
- MD or equivalent medical degree required; board certification preferred in Internal Medicine, Cardiology, Nephrology, Endocrinology, or related field.
- 10+ years of industry clinical development experience, including significant late-stage / registrational trial leadership.
- Prior experience serving as medical monitor and clinical lead for Phase 2/3 studies.
- Proven experience with NDA / BLA submission support and health authority interactions.
- Strong understanding of GCP, ICH guidelines, safety reporting, and global clinical development processes.
- Demonstrated ability to lead cross-functional teams and influence without direct authority.
- Strong scientific communication and presentation skills.
- Experience in hypertension, cardiovascular, renal, or metabolic disease strongly preferred.
These positions are eligible for standard Company benefits including medical, dental, vision, time off and 401K, as well as participating in Mineralys incentive plans are contingent on achievement of personal and company performance. Actual compensation may vary from posted hiring range based on geographic location, work experience, education, and/or skill level.
US Salary Range: $340,000 - $370,000
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