Director, Regulatory Data

3 weeks ago

London, United Kingdom Cpl Healthcare Full time

Contract length: 10 p/h (Can be flexible for right candidate)
Tadworth, Hybrid
She/he will lead the development and technical execution of PCOA strategies in the clinical trials and observational studies to optimize regulatory, HTA, and market access outcomes for therapies. The PCOA Director will be an integral member of the HTA, Value & Evidence (HV&E) Strategy organization and serve as a critical partner to cross-functional stakeholders in R&D, Medical Affairs, RWE, and Commercial organizations. Develops and leads PCOA strategies to support therapeutic area /asset specific clinical development plans, value and access strategies, integrated evidence plans, and medical affairs tactics.
Ensures that PCOA strategies are acceptable and compliant with regulatory guidance (FDA, EMA).
Provides technical expertise in the analysis, interpretation, and communication of COA data.
Manages a global network of consultants and contract organizations to execute the COA evidence generation deliverables (e.g., qualitative COA development evidence, psychometric analyses, COA qualification dossiers, etc.).
Maintains awareness of new research methods, tools, and data sources to ensure study methods represent current state of the science.
Promotes the value of patient-centered outcome assessments across the company through education and training.
Travels 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 and 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; Proven track record in COA disciplines including development of new COA, data analyses, scientific publication & input to clinical trials.
Experience preparing regulatory briefing documents and dossiers to support negotiations for COAs to support labeling.
Experience presenting and negotiating COA measurement strategies with global regulatory agencies.
Strong project management skills.
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