- Accountable to Head of Patient-Centered Outcomes (PCO).
- 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 influence the work of cross-industry consortia.
- 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.
- Strong technical expertise with a proven track record in using it to achieve positive outcomes: this role is suited for candidates who are comfortable reading and interpreting the psychometric literature and its associated statistical subfields.
- Clear understanding of relevant regulatory guidance and experience of regulatory interactions
- Experienced in influencing the work of cross-industry consortia regarding the development, validation and interpretation of evidence generated via patient-centered instruments.
- Demonstrated matrix leadership in previous roles.
- Demonstrated expertise in strategy development and delivery.
- Keen interest in collaborating with external experts.
- 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.
- Strong interpersonal, verbal, and written communication skills.
- 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
- Ph.D. in a relevant discipline is anticipated.
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Head of Methodology, Patient-Centered Outcomes - Stevenage, United Kingdom - 1054 GlaxoSmithKline Services Unlimited
Description
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people over the next 10 years. 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 are revolutionising the way we do R&D. We're uniting science, technology and talent to get ahead of disease together.
Find out more:
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Job Purpose
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. A matrix leadership role, the Head of Methodology will engage with all members of PCO to ensure excellence and innovation are at the heart of the group's approach to their work. In partnership with the Head of PCO, to whom this position will report, the Head of Methodology will develop a strategy to ensure that GSK's PCO group is industry-leading, both in terms of innovation, in the excellence of our submission packages, and in the group's ability to influence the external environment, through membership of relevant cross-industry consortia and in dialogue with regulators.
Key Responsibilities:
The responsibilities listed below outline the scope of the position. The application of these tasks may vary, based upon evolving business needs.
Basic Qualifications
Preferred Qualifications
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. 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).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. 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. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
