Director of Patient-Centered Outcomes Assessment
1 month ago
At Cpl Healthcare, we are seeking a highly skilled Patient-Centered Outcomes Assessment Director to drive our PCOA strategies for innovative therapies. This role represents patients', caregivers', and clinicians' perspectives to ensure a coordinated view on PCOA strategy and delivery across the enterprise.
The ideal candidate will lead the development and technical execution of PCOA strategies in clinical trials and observational studies to optimize regulatory, HTA, and market access outcomes for therapies. As an integral member of the HTA, Value & Evidence (HV&E) Strategy organization, you will serve as a critical partner to cross-functional stakeholders in R&D, Medical Affairs, RWE, and Commercial organizations.
Key Responsibilities- Develop and lead PCOA strategies to support therapeutic area/asset specific clinical development plans, value and access strategies, integrated evidence plans, and medical affairs tactics.
- Ensure PCOA strategies are acceptable and compliant with regulatory guidance (FDA, EMA).
- Provide technical expertise in the analysis, interpretation, and communication of COA data.
- Manage a global network of consultants and contract organizations to execute the COA evidence generation deliverables.
- Maintain awareness of new research methods, tools, and data sources to ensure study methods represent current state of the science.
- Promote the value of patient-centered outcome assessments across the company through education and training.
- Travel for work in the US and/or internationally based on business needs.
- Relevant advanced academic degree (e.g., MSc or PhD in psychology, health economics, public health, epidemiology) with 9+ years (master's degree) or 7+ years (doctorate degree) of consulting, pharmaceutical industry, or academia experience.
- At least 5 years of consulting or industry experience in COA development, with demonstrated track record of leading regulatory engagement on COA strategies.
- Strong analytical and synthesis skills of qualitative and quantitative data.
- Understanding of COA research methodology and regulatory (FDA, EMA) environment.
- Scientific rigor, autonomy, and sense of initiative.
- Ability to manage multiple priorities and projects, and balance workload and timelines.
Education: Relevant advanced academic degree (e.g., MSc or PhD in psychology, health economics, public health, epidemiology) with 9+ years (master's degree) or 7+ years (doctorate degree) of consulting, pharmaceutical industry, or academia experience and at least 5 years of consulting or industry experience in COA development, with demonstrated track record of leading regulatory engagement on COA strategies.
Location: Tadworth, Hybrid
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