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 isnt just somewhere to work its 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 early clinical development programs. This role 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 and publication). Contributes to the medical governance and regulatory reporting at the study level by collaborating with operations colleagues 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 late stage clinical development programs.

• Contributes to the development finalization and amendments of study protocols with appropriate internal/external stakeholder input while ensuring protocol fulfills strategic objective of clinical development

• Liaises with Clinical Pharmacology Medical Commercial and Asset Leads to help ensure study evaluates key aspects of the Asset Product Profile critical to product differentiation/reimbursement where possible.

• Contributes to the 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 operations colleagues and matrix study team that all regulatory reporting requirements are met.

• Co-ordinates 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 matrix 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 Qualifications:

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

• B.S. Masters Ph.D. Pharm.D. or MD with 3 plusyears of recent clinical drug development experience contributing to the scientific aspects of clinical program(s) and regulatory submission(s).

• 3plus years contributing to a team 3rd parties academic partners and subcontracted organizations.

• Experience with managing multiple programs concurrently

Preferred Qualifications:

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

• Prior experience in early clinical development (Phase 1 and 2 studies) or late stage clinical development (Phase 3 studies)

• Prior HIV drug development experience strongly preferred and antiviral or infectious disease therapeutic area

• 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

#LI-GSK

#LI-ViiV

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program ViiV offers US employees. All ViiV employees receive the same benefits options and plans as GSK employee.

Why Us

At ViiV Healthcare we will not rest until we leave no person living with HIV behind. Until the 40 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 atruly inclusive culture where were 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.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at where you can also request a call.

Please note should your inquiry not relate to adjustments we will not be able to support you through these channels. However we have created a Recruitment FAQ guide. Click the link where you will find answers to multiple questions we receive

ViiV 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

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 ViiVs 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 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 ViiVs compliance to all federal and state US Transparency requirements. For more information please visit the Centers for Medicare and Medicaid Services (CMS) website at Experience:

Manager