Clinical Scientist, Global Collab Studies – ViiV Healthcare

Job title:

Clinical Scientist, Global Collab Studies – ViiV Healthcare

Company

GlaxoSmithKline

Job description

Clinical Scientist, Global Collaborative Studies – ViiV HealthcareLocations:GSK HQ, UKDurham, USAWe’re moving towards a more sustainable future with our new headquarters. With better public transport links and proximity to world-class science and technology institutions, we’re excited for our move to the vicinity of Earnshaw Street, London WC1A (“the New HQ”) by end H1 2024.Role descriptionThis role represents a great opportunity to join the ViiV Healthcare Global Collaborative Studies Group, which currently supports over 150 investigator sponsored research (ISR) studies, generating important evidence on our products, and HIV in general, across the world.In this role, you will lead, manage and implement the company related activities and accountabilities for investigator sponsored studies and collaborative studies, with a focus on studies planned to generate data to be included in regulatory submissions.The optimal candidate will be self-motivated, have a strong scientific and research background and experience working with external investigators and research networks, in addition to having good communication and organisation skills and a proven ability to lead in a matrix environment. The individual should have a desire to support evidence generation across the ViiV portfolio and a passion for contributing to the ViiV mission of leaving no person living with HIV behind.Job PurposeTo be the Study Accountable Person (SAP) for Regulatory Supported Collaborative Studies that are planned to generate data to be included in regulatory submissions for ViiV products, in addition to managing other Investigator Sponsored Studies (ISS) and Supported Collaborative Studies (SCS).In this role you will

• Study Accountable Person (SAP) for multiple collaborative studies, including those conducted in challenging & complex situations, such as multi-country, international, network Sponsored studies providing strategically important clinical data, and certain Registrational Supported Collaborative Clinical Studies, where use of data is planned for regulatory submission:

• driving all aspects of review, implementation and conduct from contracting, Sponsor study team membership, investigator/Sponsor interactions, study milestone/budget and/or drug supply management, study documentation review, through to data disclosure.
• ensuring that data and study management are of adequate quality to allow registration of ViiV product, where applicable
• Provide scientific and strategic review and critique of Collaborative Study/Investigator Sponsored Study proposals and protocols submitted by external sponsors/collaborators to ViiV Healthcare
• Cross functional working with key internal partners; understand and maintain relationships and activities to ensure timely, compliant and efficient delivery of ViiV support for ISS and SCS, end-to-end (e.g., GSK and ViiV Safety & PV, Legal, Drug Supplies, Regulatory, Publications, Regions/LOCs)
• Establish and maintain relationships with key external investigators, HCPs, Sponsor institutions/networks. Managing external expectations and relationships which are crucial for ViiV’s ability to engage with these collaborators across a range of developmental and strategic activities, and conduct clinical research in collaboration
• Assist with regulatory submission work by contributing to Clinical Study Report (CSR) preparation and reviewing/responding to Regulatory Agency queries
• Assist with updates to regulatory documents, such as EU PIP and US PSPs.

Why you?Basic Qualifications & Skills:We are looking for professionals with these required skills to achieve our goals:

• Life Science degree (PharmD, PhD, MD, etc)
• Clinical training and/or multiple years pharmaceutical industry/clinical research experience
• Experience in clinical development and/or post-marketing studies
• Understand clinical trials from concept study to publication
• Detailed and current knowledge of HIV research and data
• Leadership experience in a matrix environment

Preferred Qualifications & Skills:Please note the following skills are not necessary, just preferred, if you do not have them, please still apply:

• Strong communication and negotiation capabilities
• Strong teamworking and relationship building skills with external and internal partners across multiple functional areas

Closing Date for Applications – 18th July 2024 (COB)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 Us?At ViiV Healthcare, we will not rest until we leave no person living with HIV behind. Until the 39 million people living with HIV is down to zero, we will continue searching for new ways to limit the impact of HIV.We are the only pharmaceutical company solely focused on combating, preventing, and ultimately eradicating HIV and AIDS. At ViiV Healthcare, we do things differently. Born out of a partnership between and in 2009, with joining in 2012, we are determined to help end the HIV epidemic. We are guided by our mission to leave no person living with HIV behind and it is this mission that unites our employees located across the globe. We combine expertise in research, manufacturing, policy and more to push the boundaries of what people think is possible in HIV treatment and care. As a result of our connection with GSK, we are able to draw on their proud history and resources. This means that you would receive all the employee benefits offered by GSK.Living our mission of leaving no person living with HIV behind means keeping inclusion and diversity at the heart of everything we do – from our breakthrough innovation, to our diverse portfolio of medicines as well as the work we do to partner with HIV communities. Having a diverse team and a truly inclusive culture where we’re all able to be ourselves and feel like we belong will make us an even stronger team, better able to perform as a business and deliver on our mission to leave no person living with HIV behind.ViiV is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, 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.Important notice to Employment businesses/ AgenciesViiV 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 ViiV’s commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to ViiV. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and ViiV. 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 ViiV. ViiV 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, ViiV may be required to capture and report expenses ViiV 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 ViiV’s compliance to all federal and state US Transparency requirements. For more information, please visit ViiV’s Transparency Reporting site.

Expected salary

Location

United Kingdom

Job date

Sat, 06 Jul 2024 00:52:04 GMT

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