- 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.
- Effectively collaborates with cross-functional stakeholders to ensure that the PCOA strategies and deliverables are fit for purpose and aligned with the overall program goals.
- Ensures that PCOA strategies are acceptable and compliant with regulatory guidance (FDA, EMA).
- Conducts qualitative and quantitative research to inform COA development.
- In collaboration with Value & Evidence and R&D colleagues, develops and disseminates COA endpoint/measurement strategy.
- 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.
- Knowledge of the drug development process.
- 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.
- Good interpersonal and communication skills, both written and oral; ability to understand and communicate with cross-functional stakeholders.
- Ability to manage multiple priorities and projects, and balance workload and timelines; Able to work in a fast-paced and dynamic environment.
- Ability to work effectively either in small teams or independently.
- Proven track record in COA disciplines including development of new COA, data analyses, scientific publication & input to clinical trials.
- Technical competency in systematic literature reviews and qualitative research.
- 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.
- Technical competency in use of ePRO/eCOA and linguistic validation of COAs.
- Strong project management skills.
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Patient Outcomes Assessment Director - Surrey, United Kingdom - Cpl
Description
Title: Director, Patient-Centered Outcomes Assessment
Contract length: 12 months
Pay rate: £32.00 to £ 46.10 p/h (Can be flexible for right candidate)
Location: Tadworth, Hybrid
Role Summary
The Patient-Centered Outcomes Assessment (PCOA) Director will drive PCOA strategies for our portfolio of innovative therapies by representing patients' perspective and preferences (as well as caregivers and clinicians) and ensuring a single and coordinated view on PCOA strategy and delivery across the enterprise. 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. As PCOA subject matter expert, she/he will foster a team culture of collaborative sharing of knowledge and co-creation.
ROLE RESPONSIBILITIES
Qualifications
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
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.
Required skills and competencies:
