HI
HillenbrandProduction Director
Directeur de Production managing production and team growth in an industrial context. Lead transformation from artisanal to efficient industrial model with operational KPIs.
About the role
- Apply technical expertise to plan and support evidence development strategies for Patient Reported Outcomes (PRO)/Clinical Outcome Assessment (COA)-related endpoints.
- Define and oversee the execution of strategies for the rigorous development and implementation of PRO/COAs across GSK’s portfolio.
- Guide the development, validation, analysis, interpretation, and utilization of PRO/COA instruments in the context of clinical trials and/or observational studies.
- Work cross-functionally to ensure the value of patient-centric endpoints is communicated early and clearly and that PRO/COAs are implemented and analysed appropriately in clinical trials.
- Support key communications with regulatory bodies by developing targeted questions related to the PRO/COA endpoint strategy and identifying the critical evidence needed for meetings to support GSK’s patient-centric endpoint strategies.
- Support broader publication strategy by planning for and contributing to external publications which present PRO/COA-related results from clinical trials and/or PRO/COA development and validation studies.
Requirements
- Bachelor’s degree in Psychology, Psychometrics, Social Sciences, Outcomes Research, Health services research, Epidemiology, Pharmacy, Public Health or a closely related discipline.
- Considerable experience in a related role with COA development and implementation in a pharmaceutical environment, particularly in drug and vaccine development, with demonstrated experience in clinical trial planning and execution.
- Clear understanding of the FDA COA/PFDD Guidance and understanding of healthcare markets and regulatory and reimbursement decision making, especially in relation to the global use of COA data in drug and vaccine development.
- Experience with managing COA development and validation projects.
- Strong background in statistical methods for the evaluation of COA endpoints.
- Understanding of the evolving methods and regulatory environment with respect to COAs.
Benefits
- competitive salary
- annual bonus based on company performance
- healthcare and wellbeing programmes
- pension plan membership
- shares and savings programme
- hybrid working model
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
BR
BrightViewCenter Director
Center Director managing the daily operations of BrightView's addiction treatment facility. Leading clinic workflow and ensuring high - quality patient experiences with a collaborative team.
PJ
Planned Parenthood of Metropolitan New JerseyDirector of Advocacy – Public Affairs
Director of Advocacy responsible for grassroots support for Planned Parenthood. Leading relationship development and supervising advocacy programming in New Jersey.
Director defining and designing pricing and contracting strategies for GSK’s pharmaceutical products. Leading the development of product launch pricing and engaging with key stakeholders for optimal contract performance.
TC
The Hershey CompanySenior Director, Consumer Insights
Senior Director Consumer Insights leading research strategies for Hershey Company. Collaborating with internal and external stakeholders to enhance consumer insights capabilities.
LG
LSEG (London Stock Exchange Group)Director, Private Markets Proposition
Proposition Manager at LSEG defining and leading strategy for Private Markets products and managing workflow solutions. Collaborating across teams to execute the growth strategy with a focus on financial markets.
Technical Director managing technology delivery, operations, and innovation across APAC at IDEMIA. Ensuring client infrastructure and systems are implemented and managed to the highest standards.
AV
F&B Multi - Unit Director II overseeing restaurant operations at HMSHost. Managing staffing, financial standards, and operational efficiencies across multiple locations.
GU
Senior Director overseeing technology engagements from strategy through execution in the Financial Services domain. Enhancing client solutions and mentor technology teams for successful project delivery.
GU
Director of Cloud and Application Development leading a high - performing team at Guidehouse. Focus on cloud - native solutions and accelerate solution architecture efforts in a global delivery model.