ViiV Healthcare (GSK) Manager, Clinical Development

GSK • Greenville, NC

1d

About The Position

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 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…

Requirements

• B.S., Masters, Ph.D., Pharm.D., or MD with 3 plus years of recent clinical drug development experience contributing to the scientific aspects of clinical program(s) and regulatory submission(s).
• 3 plus years contributing to a team, 3rd parties, academic partners, and subcontracted organizations.
• Experience with managing multiple programs concurrently

Nice To Haves

• 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

Responsibilities

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree