Head of Methodology, Patient-Centered Outcomes

4 weeks ago

Stevenage Hertfordshire, United Kingdom GlaxoSmithKline Full time

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology and disease mechanisms, and transform medical discovery. We’re uniting science, technology and talent to get ahead of disease together.
The Head of Methodology in Patient-Centered Outcomes (PCO) is responsible for ensuring that the best and most relevant methods are used in the design, deployment and interpretation of patient-centered instruments within clinical development plans, across all of GSK’s therapeutic portfolios. To ensure that the development and validation of instruments meet scientific and regulatory requirements.
To ensure that the work of PCO members of project teams is of the highest scientific quality, maximizing the probability that the evidence generated from the use of such constructs lead to successful submissions and engagements with payers.
To ensure the integrity of claims made on the basis of evidence generated by a patient-centered outcome, and to develop such required internal stakeholder partnerships to ensure this happens.
To understand and meet the requirements of all relevant GSK policies, SOPs and external regulations clearly and fully. To understand and comply with local codes of practice, guidelines, and laws to ensure the strictest requirements are met particularly with respect to delivery of promotional versus non-promotional activities.
Bachelors degree in quantitative discipline such as epidemiology, outcomes research, health services research, health informatics, or biostatistics
Strong, relevant experience in the field of the development and application of instruments for use in measuring Patient-Centered Outcomes.
Clear understanding of relevant regulatory guidance and experience of regulatory interactions
Ability to prioritize and manage multiple projects simultaneously.
Track record of building strong internal and external networks.
Demonstrated ability to manage complexity and cultural diversity.
A strong understanding of drug development processes and strategies, with proven ability to guide the analysts to effectively engage with matrix stakeholders and apply statistical thinking to meet project and/or business objectives
We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only).
We believe in an agile working culture for all our roles. recruitment@gsk.We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit GSK’s Transparency Reporting For the Record site.
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