- 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.
-
Deputy Director, Assessments Staff
1 week ago
Cabinet Office London, United Kingdom**Details**: · **Reference number**: · **Salary**: · - £73,000 - £117,800- · **Job grade**: · - SCS Pay Band 1**Contract type**: · - Permanent · - Fixed Term · - Loan**Length of employment**: · - This role is being offered on a permanent basis for external appointees or 2 year fi ...
-
Cost Assessment Associate Director
4 days ago
KPMG-UnitedKingdom London, United Kingdom**Job description** · **The Group** · KPMG's Infrastructure Group in the UK consists of over 200 professionals and is widely recognised as one of the world's leading independent financial and business advisers in infrastructure. · We provide in-depth advice on the strategic, fina ...
-
Project Assessment Director
4 days ago
Revalue Nature Ltd United KingdomJoin to apply for the Project Assessment Director role at Revalue Nature · 2 days ago Be among the first 25 applicants · Join to apply for the Project Assessment Director role at Revalue Nature · Save this job with your existing LinkedIn profile, or create a new one. Sav ...
-
Project Assessment Director
1 week ago
Revalue Nature Ltd United Kingdom1 day ago Be among the first 25 applicants · Revalue exists to deliver a fundamental step-change in the quality and integrity of carbon projects. We do this by rethinking projects from the ground up - slightly better is not good enough - in order to build confidence in the marke ...
-
Project Assessment Director
1 week ago
Revalue Nature London, United KingdomRevalue exists to deliver a fundamental step-change in the quality and integrity of carbon projects. We do this by rethinking projects from the ground up - slightly better is not good enough - in order to build confidence in the market and deliver impact at a planetary scale. Our ...
-
Project Assessment Director
6 days ago
Revalue Nature London, United KingdomRevalue exists to deliver a fundamentalstepchange in the quality and integrity of carbon projects. We dothis by rethinking projects from the ground up slightly better isnot good enough in order to build confidence in the market anddeliver impact at a planetary scale. Our world ca ...
-
Project Assessment Director
1 week ago
Revalue Nature London, United Kingdom EmployeeRevalue exists to deliver a fundamental step-change in the quality and integrity of carbon projects. We do this by rethinking projects from the ground up - slightly better is not good enough - in order to build confidence in the market and deliver impact at a planetary scale. Our ...
-
Patient Outcomes Assessment Director
1 week ago
Cpl Healthcare London, United KingdomTitle: 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 st ...
-
Central London Community Health Trust London, United KingdomAssociate Medical Director (2PAs) Associate Medical Directors (AMDs) are Senior Medical leads that are accountable for a significant but focused area of the medical leadership portfolio. In conjunction with the Medical Directorate leadership team you will lead and direct your rel ...
-
Enquiries and Admissions Officer
20 hours ago
Help Me Stop Ltd. London, United KingdomDo you enjoy making a positive impact in the lives of others? Work In Progress Healthcare Ltd trading as Help Me Stop is a leading resource for people seeking access to affordable private outpatient face to face and online drug and alcohol treatment in the UK. With centers in Lon ...
-
Patient Outcomes Assessment Director
1 week ago
Cpl Surrey, United Kingdom FreelanceTitle: 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 strate ...
-
Assistant Psychologist
1 week ago
South West London and St Georges Mental Health NHS Trust London, United KingdomThe CYP Neurodevelopmental Assessment Team is one of three dedicated services formed from the 2014 service transformation model which features dedicated and local services in the directorate. We are an expanding, highly specialist team, combining expertise in CYP neurological dis ...
-
Health & Safety Adviser
2 days ago
King's College London London, United KingdomJob id: Salary: Grade 6, £40,386 - £47,414 per annum, including London Weighting Allowance. · Posted: 23 January 2024. Closing date: 18 February 2024. · Business unit: Health & Safety Services. Department: Health & Safety Services. · Location: Guy's Campus. Category: Professional ...
-
Project Director
1 week ago
Pro-Finance Recruitment Group London, United KingdomProject Director · London/Hybrid · **Salary - £88,324.50** · This body serves the UK public good by influencing and contributing to the research and development of high-quality international financial reporting standards and their adoption for use in the UK. It will do this by: · ...
-
Head of Occupational Therapy
4 days ago
East London NHS Foundation Trust London, United KingdomAn exciting opportunity has arisen for an experienced and dynamic Occupational Therapist to join the Forensic Service as Head of Occupational Therapy as a permanent staff member. · You would be based within a busy service working with service users with severe and enduring mental ...
-
Executive Assistant
1 week ago
Ofgem London, United KingdomThis is an exciting time to join Ofgem and this role puts you at the heart of the organisation, providing a full range of executive support to the Director within the portfolio assigned. With exposure to a wide variety of projects and people, you'll have plenty of opportunity to ...
-
Sustainability Design Assistant
1 week ago
Perkins+Will London, United KingdomAt Perkins&Will we aspire to go above and beyond the standard definition of "sustainability," and this new role in the Perkins&Will London studio will assist our team in breaking boundaries / making new ground in sustainability through the delivery of our multi aspect, holistic e ...
-
Specialist in Consumer Investments
1 week ago
Financial Conduct Authority London, United KingdomBackground · The FCA is responsible for regulating the conduct of 50,000 firms and is focused on creating a fair and more resilient financial system. We are a diverse organisation and aim to be representative of the whole UK. We want to reflect the society we serve better; we wan ...
-
Head of Assessment
1 week ago
Page Group London, United KingdomTo take strategic responsibility and accountability for the development and delivery of assessments and qualifications to assure City & Guilds' global reputation and competitiveness as a leading vocational education business. · **Client Details** · City & Guilds are the UK's larg ...
-
Programme Lead
1 week ago
King's College Hospital NHS Foundation Trust London, United KingdomThe dental care group at Kings College Hospital NHS Foundation Trust and Kings College London are seeking to appoint a full time Programme Director Programme for the Dental Therapy and Hygiene course. The post holder will work closely with the Clinical Director (KCH), General Man ...
Patient Outcomes Assessment Director - London, United Kingdom - Clinical Professionals Limited
Description
Reference Number: JO
Patient Outcomes Assessment Director
Rate: Negotiable
Job Type: Contract
Location: Tadworth
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: