高级主任，健康经济学与结果研究/真实世界证据（HEOR/RWE）
Associate Director, Health Economics & Outcomes Research/Real-World Evidence (HEOR/RWE)
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其相关合并症（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。
职位概述：
HEOR/真实世界证据（RWE）高级经理在制定和执行支持我们创新疗法的临床和经济价值的证据策略中发挥战略和科学领导作用。该职位负责设计和提供真实世界和结果研究证据，以支持医学事务、市场准入和监管目标。该角色专注于生成高质量、决策相关的证据，包括观察性研究、外部对照组和经济模型，以及间接治疗比较，以阐明临床结果、展示价值并支持利益相关者的决策。
该高级经理与医学事务、统计学和商业团队进行跨职能合作，同时与学术研究人员、关键意见领袖和数据供应商等外部合作伙伴互动。该角色参与战略证据规划、科学沟通，并在矩阵式组织中推动真实世界数据能力的发展。
主要职责：
- 领导 HEOR 和 RWE 研究的设计、执行和监督，包括观察性研究（回顾性/前瞻性队列）、经济模型、外部对照组和间接治疗比较。
- 监督数据分析，确保方法严谨性，并为内部和外部消费的研究报告做出贡献。
- 制定并执行与产品开发和市场准入需求一致的整合 HEOR 策略。
- 识别证据缺口并定义研究策略，以解决未满足的需求、疾病负担和治疗路径。
- 支持价值信息工具的开发（例如，成本效益模型、预算影响模型）。
跨职能协作与利益相关者参与
- 与医学事务部门进行跨职能合作
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.
Position Summary:
The Associate Director, HEOR / Real-World Evidence (RWE) plays a strategic and scientific leadership role in developing and executing evidence strategies that support the clinical and economic value of our innovative therapy. This position is responsible for designing and delivering real-world and outcomes research evidence to support medical affairs, market access, and regulatory objectives. The role focuses on generating high-quality, decision-relevant evidence, including observational studies, external control arms, and economic models, and indirect treatment comparisons, to contextualize clinical outcomes, demonstrate value, and support stakeholder decision- making.
The Associate Director collaborates cross-functionally with Medical Affairs, biostatistics, and commercial teams, while also engaging external partners such as academic researchers, key opinion leaders, and data vendors. This role contributes to strategic evidence planning, scientific communication, and advancing real-world data capabilities within a matrixed organization.
Key Responsibilities:
- Lead the design, execution, and oversight of HEOR and RWE studies, including observational studies (retrospective/prospective cohorts), economic models, external control arms and indirect treatment comparisons.
- Oversee data analysis ensuring methodological rigor and contribute to research reports for internal and external consumption.
- Develop and execute integrated HEOR strategies aligned with product development and market access needs.
- Identify evidence gaps and define research strategies to address unmet needs, burden of disease, and treatment pathways.
- Support development of value messaging tools (e.g., cost-effectiveness models, budget impact models).
Cross-functional Collaboration & Stakeholder Engagement
- Partner cross-functionally with Medical Affairs, Clinical Development, Market Value & Access and Commercial teams to align with data needs.
- Build and manage relationships with external experts, academic collaborators, and vendors.
- Provide HEOR/RWE expertise to support interactions with HTA agencies.
- Lead publication planning and development of HEOR/RWE abstracts, manuscripts, and presentations for scientific congresses and peer-reviewed journals.
Operational Leadership & Governance
- Oversee vendor selection and management, ensuring timely, high-quality study execution.
- Manage timelines, budgets, and deliverables across multiple projects
- Ensure all HEOR activities adhere to compliance guidelines, internal SOPs, regulatory standards, and ethical guidelines for RWD and economic modeling.
Qualifications:
- Advanced degree required (PhD, PharmD, MD, MPH, or similar) in health economics, outcomes research, biostatistics, epidemiology or related field.
- Minimum of 5 years of relevant experience in HEOR, RWE, or outcomes research in pharmaceutical, biotech, consulting, or academic settings.
- Strong analytical skills and strong understanding of observational study design, real-world data sources (claims, EMR, registries), and health economic modeling.
- Experience with burden of illness studies, and comparative effectiveness research.
- Familiarity HTA requirements and RWE regulatory landscape.
- Demonstrated ability to successfully lead complex research projects independently and collaboratively.
- Strong communication, and scientific writing skills, including publication track record.
- Proven cross-functional collaboration and stakeholder engagement capabilities.
Travel:
- This position requires up to 20% travel. Frequently travel is outside the local area and overnight.
US Salary Range: $175,000 - $200,000
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