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.
The Role
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.
Key Responsibilities
* 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.
* Works within the study team to help to create evidence generation and scientific outputs including content of investigator meeting, clinical study report, and preparation of regulatory 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.
Basic Qualifications
* 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.
* 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.
Preferred Qualifications
* 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.
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, parental status, national origin, age, disability, genetic information, military service or any basis prohibited under law.
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