Company Overview

ViiV Healthcare is a global specialty HIV company, the only one that is 100% focused on researching and delivering new medicines for people living with, and at risk of, HIV. ViiV Healthcare is highly mission-driven in our unrelenting commitment to being a trusted partner for all people living with and affected by HIV. Our aim is to think, act, and connect differently through a focus on education on for the prevention and treatment for HIV. We go to extraordinary lengths to deliver the sorts of breakthroughs, both in prevention, treatments, care solutions and communities, that really count. We go beyond the boundaries of medicine by taking a holistic approach to HIV through developing and supporting sustainable community programs and improving access to care. We are fully committed to push through every challenge until HIV/AIDS is eradicated. ViiV Healthcare has played a significant part in delivering breakthroughs that have turned HIV into a manageable health condition. We offer the largest portfolio of HIV medicines available anywhere, and we continue our work to cater for the widest possible range of needs in response to the HIV epidemic.

We are aware of how much is at stake for those at-risk or affected by HIV and we show up every day 100% committed to the patients. Our work culture is fast-paced, diverse, inclusive, competitive, and caring. But ViiV Healthcare isn’t just somewhere to work – it’s a place to belong, an invitation to bring your very best, and a team full of impact-driven team members who are hungry to make a difference.

While we have been improving lives of HIV patients for 30 years, this is an especially exciting time to be at ViiV Healthcare, as we evaluate novel approaches to treatment and prevention that could further reduce the impact of HIV on individuals and communities.

Job Duties

• Take ownership for all or part of the non-GLP in vivo toxicology studies and DMPK studies. as needed associated with a Discovery compound, with direct engagement with the ViiV Senior Director of Discovery Toxicology and appropriate GSK staff, fully understanding issues on the studies monitored and driving consistency within and across projects.
• For a given Discovery project, work with appropriate ViiV and GSK staff to deliver a coordinated approach to the design and reporting of non-GLP studies, and to keep abreast of study issues.
• Be single point of accountability for all aspects of the conduct of non-GLP in vivo general toxicology studies and studies in support of formulation selection within GSK and at Contract Research Organizations (CROs) to meet project needs and company-wide drug development timelines.
• Develop protocols in association with Study Director, ViiV and GSK staff and where needed present at appropriate forums (GPRF, etc.) to obtain approval. Coordinate timing and logistics of study conduct (ie formulation sterilization, shipment, bioanalytical sample shipment, etc).
• Monitor study progress in a detailed manner and communicate ongoing study activities within ViiV and, where appropriate, GSK.
• Review all documents for quality, accuracy, scientific integrity and alignment with ViiV’s policies and procedures and, where appropriate/applicable, GSK requirements.
• Manage issues as they arise during study and report study findings.
• Coordinate report review, assemble contributing reports, archiving in appropriate systems/platforms.
• Finalize study reports in association with ViiV and GSK staff, and key contributing scientists.
• Collaborate with ViiV, CRO and, where appropriate, with GSK to resolve scientific, technical and/or quality issues and improve study consistency, quality, efficiency and effectiveness. Share appropriate and necessary information to advance the Study Director and operational staff’s understanding of the study work to be conducted at the CRO.
• Facilitate early development feasibility studies for new formulation approaches, coformulated products, microneedles, predictive ISR evaluations, and other exploratory activities that occur outside of the discovery project teams but in support of project teams and broader platform advancement teams.
• Travel to CROs and/or GSK and ViiV sites when appropriate.
• Work directly with others in ViiV and GSK across sites, such as Drug Dispensaries, Principal Investigators (PIs), Project Managers and Project Team Members to optimize CRO study efficiency and quality and help develop timelines to reach milestones.
• Ensure critical report dates are met, and any delays are communicated and captured accurately.
• Request blanket purchase orders (POs) under which studies in support of programs of work are conducted.
• Review and approve CRO invoices; monitor associated PO balances.
• For in vivo studies supporting programs of work, and where necessary, prepare research initiation forms (RIFs) using GSK animal welfare risk review database (AWRRD); submit for review and subsequent approval.
• Review ELNBs generated by other team members.
• Provide toxicology support and consultation to Discovery teams as appropriate, in conjunction with the Senior Director of Discovery Toxicology.

Why you?

Basic Qualifications:

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

• Bachelor's Degree
• 10 years of relevant experience in the pharmaceutical industry or CRO

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Ability to implement a six-month planning horizon
• Understanding of actives, raw materials and their function and how they are brought together to form a stable, functioning product from prototype evaluation to commercial launch
• Demonstrate communication skills with external key opinion leaders/experts in specific therapeutic areas or scientific disciplines
• Knowledge of related disciplines and how research in formulation should be designed to take account of related disciplines
• Demonstrate good judgment and effective decision making in applying expertise to move multiple scientific or technical projects forward

Why ViiV?

At VIIV HEALTHCARE, we have already achieved unprecedented change over the past four years, improving R&D, becoming a leader in consumer healthcare, strengthening our leadership and transforming our business execution. Today, we're making the most significant changes we've made to our business in over 20 years.

We are on track to separate and create two new companies in 2022: New ViiV HEALTHCARE with a portfolio of leading vaccines and specialty medicines as well as R&D based on immune system science and genetics; and a new world-leading consumer healthcare company with valued and trusted brands.

A new ambition comes with a new goal. For New VIIV HEALTHCARE, it's about uniting science, talent and technology to get ahead of disease – all with a clear ambition to impact human health, achieve greater and more sustainable returns for shareholders and create a new VIIV HEALTHCARE where exceptional people thrive.

Getting ahead means preventing diseases as well as treating them.

We will achieve this through our people and our culture.

A culture that is ambitious for patients – so that we deliver what's important better and faster; Responsible for impact – with clear ownership of goals and support for success; and where we do what is right.

So if you're ready to improve the lives of billions of people, join us at this exciting time in our journey.

Join our challenge to move forward together.

NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization

#LI-GSK

#LI-ViiV

At ViiV Healthcare, we will not rest until we leave no person living with HIV behind. Until the 38 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 GSK and Pfizer in 2009, with Shionogi 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.

If you require an accommodation or other assistance to apply for a job at ViiV, please contact the ViiV Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

ViiV is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that 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/ Agencies

ViiV 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 For the Record site.