Director Patient-Centred Outcomes Assessment

Location

Surrey | United Kingdom

Job description

DETAILS:

• Full-time contract position
• ASAP start for minimum 12 month contract
• Hybrid working (office based in Surrey)
• Competitive daily rate of pay
• Global pharma company

THE ROLE:

• The Patient-Centered Outcomes Assessment (PCOA) Director will drive PCOA strategies for our Client’s 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.
• They 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 Client’s 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.
• 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 Client through education and training.

Full job description available on application

THE CANDIDATE:

Education:

Relevant advanced academic degree (e.g., MSc or PhD in psychology, health economics, public health, epidemiology)

Required skills and competencies:

• Knowledge of the drug development/clinical trial process.
• Strong analytical and synthesis skills of qualitative and quantitative data.
• Understanding of COA research methodology and regulatory (FDA, EMEA) environment
• Understanding and experience with PRO questionnaires and developing clinical outcome assessments from either pharmaceutical or vendor side.
• Review of dossiers for FDA and MEA submissions
• 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;
• Please note that only candidates currently living in the UK with Right To Work in the UK in place will be considered.

TO APPLY:

Please complete the details below to apply. For further information or a discreet discussion regarding your recruitment requirements, please call Alex on 01227 844466 or email [email protected]

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Apex Recruitment are a specialist agency providing opportunities within the pharmaceutical, biopharma, biotech and medical device industries recruiting in the areas of medical affairs, drug safety, clinical and quality.

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