Clinical Scientist, Global Collaborative Studies

Clinical Scientist, Global Collaborative Studies

Location: GSK House

Open to discuss flexible working arrangements

We’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.

As a Clinical Scientist in the ViiV Healthcare (VH) Collaborative Studies Group, you will be primarily responsible for activities relating to: the provision of safety, risk mitigation and pharmacovigilance (PV) support for the use of VH assets in VH supported studies (investigator sponsored studies [ISS] and supported collaborative studies [SCS] conducted with partner organisations); and ensuring the fulfilment of VH safety data exchange requirements as part of the legal agreements for these studies.

The purpose of your primary role and responsibilities are to enable: Sponsors to adequately safeguard study participants from the key side effects with VH medications; and VH to meet regulatory obligations as product developer and/or license holder, such as signal detection and management.

In addition, your role will develop to also support more general ISS and SCS activities including specific study accountabilities and management, as a Study Accountable Person (SAP).

Key Responsibilities

• Run safety, risk mitigation and PV related activities and processes for VH supported studies including: update and maintenance of applicable SOPs/Policies, guidance documents, work flows and safety review forms for study proposals, protocols, ICFs and legal agreements; development and implementation of safety training for relevant partners; oversight and support of SAPs safety accountabilities during study conduct; input to legal agreement safety data exchange clauses; consulting on impact of PV legislation; implementation and conduct of routine management monitoring oversight and other tracking activities, and documenting these for inspection readiness; and overall process improvement.
• Support Regional ISS and SCS activities and meetings; provide support to Regional Leads and local SAPs to ensure studies are progressed in a timely manner, and data are delivered with an appropriate sense of urgency, through timely resolution of study issues consistent with relevant policies and procedures.
• Study Accountable Person (SAP)– 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.
• Cross functional working with key internal partners; understand and maintain relationships and activities to ensure timely, compliant and efficient delivery of VH support for ISS and SCS, end-to-end (e.g., GSK and VH Safety & PV, Legal, Drug Supplies, Regulatory, Publications, Regions/LOCs)

Why you?

We are looking for professionals with these required skills and characteristics to achieve our goals:

• Experience in the pharmaceutical industry in a clinical research /medical role
• BSc (Hons) in Biology, Clinical or Medical Science or equivalent health care-related specialty (Master’s degree or PhD would be preferred)
• Pharmacovigilance experience relating to clinical safety reporting/data exchange and risk management
• Knowledge/experience of international pharmacovigilance requirements (e.g., ICH, GVP modules, CIOMS initiatives) and clinical development process (from Phase 1 to Phase IV).
• Self-motivated, highly organised and have experience co-ordinating multiple projects
• Ability to assimilate, interpret and disseminate sophisticated scientific and medical concepts and information
• Excellent technical writing skills, high degree of accuracy with attention to detail, for authoring clear reports that may be the subject of regulatory inspection
• Clear communications written and spoken to produce and present training materials for multi-national internal and external audiences.
• Solution focussed and creative, with proven track record to solve sophisticated problems and identify process improvements
• Computer literate, able to become familiar with new systems and software easily
• Ability to work effectively in a team and matrix environment, with proven track record to influence and negotiate with internal partners at all levels in the company
• Ability to establish and maintain mutually encouraging external/customer facing relationships

Why ViiV Healthcare?

ViiV Healthcare is a global specialist HIV company combining the HIV expertise of GSK, Pfizer, and Shionogi. We have a broad portfolio of antiretroviral medicines, an industry-leading pipeline, and several first-of-their-kind programmes to improve access to medicines and support novel on-the-ground community initiatives.

ViiV Healthcare’s global HQ is based in the offices of GSK, its largest shareholder, in Brentford, London. It has established a direct presence in 13 countries and works closely with GSK to distribute HIV medicines elsewhere in the world. We are uniquely positioned to be at the forefront of advancing HIV treatment and care because we are the only pharmaceutical company that is 100% focused on HIV.

Through our focus on patient-centered innovation we have developed a strong portfolio of medicines that are advancing treatment and care for people living with HIV around the world. Our broad product portfolio includes a range of therapeutic options throughout the treatment spectrum. The primary focus is on the growth portfolio namely dolutegravir and cabotegravir based regimens as well as a small number of newly acquired assets.

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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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.

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