ViiV Healthcare (GSK) Clinical Development Manager

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 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 and treatment for HIV. We go to extraordinary lengths to deliver the sorts of breakthroughs, both in 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 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 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 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, as we evaluate novel approaches to treatment and prevention that could further reduce the impact of HIV on individuals and communities. The core purpose of the Manager, Clinical Development is to provide scientific leadership, direction, and contribution to the strategy employed in ViiV Healthcare clinical development programs. This role also includes contribution to the study team in the design and development of high quality, timely studies ('end to end' from Commit to Study to reporting, submission and publication). This role contributes to governance and regulatory reporting at the study level by collaborating across functional lines to ensure accuracy, quality, and timeliness of study results. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Contributes to ViiV Healthcare early- and/or late-stage clinical development programs. Leads the development, finalization, and amendments of study protocols with appropriate internal/external stakeholder input while ensuring protocol fulfils strategic objective of clinical development. Liaises with Operations, Clinical Pharmacology, Medical, Regulatory and Commercial Leads to help ensure study evaluates key aspects of the Asset Product Profile critical to product differentiation/reimbursement where possible. Provides scientific oversight of clinical studies, including assurance that data collection and study analysis plans are aligned with the protocols, thereby allowing for intended scientific interpretation of study data and results. Partners with study team to ensure that all regulatory reporting requirements are met. Collaborates with physicians and other study team members and stakeholders to enable appropriate review of safety data. May assist in identification of safety review committee members and preparation of interim safety review charter document. Works closely with study physician(s) to help monitor safety and benefit/risk for studies. Works within the study team to help to create evidence generation and scientific outputs including content of investigator meeting, clinical study report, preparation of study results for scientific meetings, congresses, and external journal publications, preparation of regulatory documents, and other relevant study documents. Partners with clinical operations colleagues to help ensure optimal delivery of study while maintaining close collaborations with other functions supporting the study. Contributes to quality assurance and inspection readiness activities. Why You? Basic Qualification We are seeking professionals with the following required skills and qualifications to help us achieve our goals B.S., Masters, Ph.D., Pharm.

D., or MD with 3 plus years of recent clinical drug development experience in a pharmaceutical industry or CRO environment contributing to the scientific aspects of clinical program(s) and regulatory submission(s). Prior drug development experience in HIV, infectious diseases or other relevant therapy area. Experience in working with or writing study protocols, informed consent forms and clinical study reports. Experience with reviewing and interpreting of clinical and scientific data. 3 plus years contributing to a cross-functional team, including internal and external partners (e.g. 3rd parties, academic partners, and subcontracted organizations). Preferred Qualification If you have the following characteristics, it would be a plus Prior HIV or antiviral drug development experience strongly preferred Ability to respond with confidence to complex study questions using sound judgment and interpretation of applicable data Ability to communicate complex scientific information concisely and clearly Ability to influence (internally and externally) without formal authority Experience with managing multiple programs concurrently #LI-ViiV #LI-GSK Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people. If you require an accommodation or other assistance to apply for a job at GSK, please contact the appropriate Recruitment Staff by emailing us at - usrecruitment.adjustments@gsk.com GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. Important notice to Employment businesses/ Agencies GSK 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 GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. 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

GSK. GSK

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, GSK may be required to capture and report expenses GSK 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 GSK's compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/ 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 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.