Senior PRO/COA Strategy Consultant
高级 PRO/COA 战略顾问通过为更广泛的资产证据策略提供专业化患者中心测量专业知识来支持不断增长的开发项目组合。多个计划正在早期发展中，研究设计完成之前需要制定有关兴趣概念，测量策略，仪器选择和终点规划的基本决策。该人员将补充内部能力并帮助确保在早期阶段，跨功能和共同开发活动中及时，技术上严格的 PRO/CoA 支持。项目特定和机密信息将在完成适用的合同和保密要求后，只根据适当情况进行共享。你所做的 · 与资产领先者合作开发和维护资产证据战略的 PRO/COA 组件。·开展疾病，患者经验，竞争性，监管和终点景观审查。·从概念到完成的 FITPRO/ COA 证据生成研究，包括研究设计，协议开发，供应商监督，科学解释和发现传播。·制定或完善概念模型并确定和优先考虑有趣的概念。· 评估现有 PRO/COA 工具，以确定其适用性和证据缺口。·支持终点战略开发和 Coa 的证据生成计划。·为协议，终点部分，统计分析计划以及相关研究文件提供技术审查和输入。·准备明确的建议，决策支持材料和文档用于跨职业审查。·与资产领导协调参与有关内部和合作伙伴面向的工作会议，作为 PRO/CoA 主题专家参加相关工作会议。·根据需要支持供应商参与和监督对可分辨的 COA 证据生成活动。预计，该角色将是战略性和科学性的，而不是主要集中在行政或项目管理上。你需要什么 · 在相关领域中先进学位，如研究结果，心理测量学，流行病学，心理学，公共卫生或相关学科。· 药品，生物技术，咨询或监管环境中有8年或以上的相关 PRO/COA 经验。· 证明开发 PRO/ COA 层次。
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The Senior PRO/COA Strategy Consultant supports a growing portfolio of development programs by contributing specialized patient-centered measurement expertise to broader asset evidence strategies. Several programs are in early development, where foundational decisions regarding concepts of interest, measurement strategy, instrument selection, and endpoint planning need to be established before study designs are finalized.
This person will supplement internal capacity and help ensure timely, technically rigorous PRO/COA support across early-stage, cross-functional, and co-development activities. Program-specific and confidential information will be shared only as appropriate following completion of applicable contracting and confidentiality requirements.
What You’ll Do
- Develop and maintain the PRO/COA components of asset evidence strategies in partnership with asset leads.
- Conduct disease, patient-experience, competitive, regulatory, and endpoint landscape reviews.
- Lead fit-for-purpose PRO/COA evidence-generation studies from concept through completion, including study design, protocol development, vendor oversight, scientific interpretation, and dissemination of findings
- Develop or refine conceptual models and identify and prioritize concepts of interest.
- Assess existing PRO/COA instruments for fitness for purpose and identify evidence gaps.
- Support endpoint strategy development and COA evidence-generation planning.
- Provide technical review and input for protocols, endpoint sections, statistical analysis plans, and related study documents.
- Prepare clear recommendations, decision-support materials, and documentation for cross-functional review.
- Participate as the PRO/COA subject matter expert in relevant internal and partner-facing working sessions, coordinated with the asset lead.
- Support vendor engagement and oversight for discrete COA evidence-generation activities, as needed.
The final assignment mix and priorities will be confirmed with the selected resource. The role is expected to be strategic and scientific, rather than primarily administrative or project-management focused.
What You’ll Need
- Advanced degree in a relevant field such as outcomes research, psychometrics, epidemiology, psychology, public health, or a related discipline.
- Approximately 8 or more years of relevant PRO/COA experience in pharmaceutical, biotechnology, consulting, or regulatory settings.
- Demonstrated experience developing PRO/COA strategies for clinical development programs, preferably including early development.
- Strong knowledge of patient-focused drug development, instrument selection, content validity, psychometric evidence, meaningful-change interpretation, and endpoint positioning.
- Experience reviewing clinical protocols, statistical analysis plans, and regulatory or evidence-planning documents.
- Ability to synthesize complex evidence and communicate clear recommendations to cross-functional stakeholders.
- Demonstrated ability to work independently, manage competing priorities, and operate effectively in a matrixed and co-development environment.
- Experience in immunology, dermatology, gastroenterology, or neurology is desirable but not required.
Originally posted on Himalayas