Clinical Evidence Partner, Digital Health & Devices
- Brentford, United Kingdom
Site Name: UK - London - Brentford
Posted Date: Oct 7 2020
The opportunity to transform healthcare, and to transform how we do business, through digital innovation and novel technologies has never been greater. At GSK Consumer Healthcare (GSKCH) our goal is to be at the forefront of this transformation to help people to feel better, do more and live longer.
As Global Clinical Evidence Partner, Digital Health & Devices, you will lead and deliver on evidence generation projects for our growing Digital Health & Devices portfolio.
You will use your experience and expertise in clinical research to drive the design, development and delivery of clinical programs, individual studies and real-world evidence (RWE) to support GSK's growing digital health & devices pipeline and demonstrate the value of these products.
You will work closely with the Global Medical Lead for Digital Health & Devices and other stakeholders to set a compelling vision for what evidence is needed, how it can be generated and how it will satisfy the needs of consumers, healthcare professional and regulators around the world. In addition, you will be expected to evaluate, pioneer and support the roll out of novel approaches to evidence generation, including RWE.
As digital health is a dynamic field, you will need to keep up to date with emerging technology and regulations as they relate to both clinical research as well as regulation of digital health products and devices, including diagnostic devices. You will have frequent and significant interaction with a number of internal teams including NEXT (digital health incubator), Digital & Tech, Medical Affairs, Regulatory, Clinical Development and Biostatistics & Data Management. Externally you will engage with investigators, academic institutions, clinical research organizations, regulators, technology partners, startups, healthcare professionals and healthcare organizations.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
- Proactively identify business opportunities and challenges where clinical evidence can add value
- Define, pioneer and drive evidence generation strategies that demonstrate the safety, efficacy and value of GSK's digital health & devices portfolio throughout the lifecycle: innovation, proof-of-concept, product development, regulatory approval, post- launch, HCP and consumer claims
- Deliver clinical evidence in support of 'beyond the pill' (drugs + digital) solutions that demonstrate how such solutions improve consumer / patient experience and or outcomes.
- Develop and execute research plans and studies using a combination of classical and novel evidence generating methodologies
- Develop digital tools and biomarkers that can be deployed in clinical research programs
- Identify & assess the capabilities of external contract research organizations (CROs)
- Help shape new GSK policy in partnership with global regulatory agencies where these aren't established, comply with GSK pathways where they already exist.
- Ensure that all clinical evidence generating activities meet with the requirements of GCP and any relevant industry and regulatory standards.
- Keep up to date with latest developments and provide cutting edge clinical research and RWE expertise to the business
- Develop yourself to become a subject matter expert and one of the "faces" of GSK's Digital Health & Devices team through engagement and collaboration with external agencies, healthcare professionals, leading thinkers, professional societies, regulators, trade associations, healthcare organizations and consumers.
- Ensure compliance with GSK data disclosure requirements
- Work to support the development of a high-performance culture
APPLICATION CLOSING DATE - 30th October 2020
Please take a copy of the Job Description, as this will not be available post closure of the advert.
When applying for this role, please use the 'cover letter' of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.
Why you? Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
- BSc level degree in life sciences (or equivalent)
- Experience of working effectively within international cross-functional teams
- Experience of working with internal and external stakeholders to design, manage and deliver clinical research projects on schedule and within budget
- Experience of creating partnerships with external parties to generate/acquire clinical data
- Ability to identify & assess the capabilities of contract research organizations
- Experience in generating and handling real world data & evidence (RWD/RWE)
- A passion for digital health and a willingness to embrace innovative approaches to clinical evidence generation, including real-world evidence
- Understanding of the differing evidence needs of consumers, regulators, clinicians and payors with regard to medical devices and digital health products, and the ability to engage with these external stakeholders as projects require
- Demonstrated business acumen and ability to work as part of a large, complex matrix organization
If you have the following characteristics, it would be a plus:
- Higher Degree ~ PhD, PharmD or professional qualification (MD or equivalent)
- Knowledge of medical device regulation
- Knowledge of in-vitro diagnostic device regulation
- Experience of delivering clinical evidence in support of digital health products & solutions
- Basic understanding of health economics
Why GSK? Our values and expectations are at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
- Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Continuously looking for opportunities to learn, build skills and share learning.
- Sustaining energy and well-being
- Building strong relationships and collaboration, honest and open conversations.
- Budgeting and cost-consciousness
As a company driven by our values of Patient focus, Transparency, Respect and Integrity, we know inclusion and diversity are essential for us to be able to succeed. We want all our colleagues to thrive at GSK bringing their unique experiences, ensuring they feel good and to keep growing their careers. As a candidate for a role, we want you to feel the same way.
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 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.
Please don't hesitate to contact us if you'd like to discuss any adjustments to our process which might help you demonstrate your strengths and capabilities. You can either call us on 0808 234 4391, or send an email email@example.com
As you apply, we will ask you to share some personal information which is entirely voluntary. 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. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.
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