Clinical Development Manager

Job description

Nombre del sítio: GSK House
Fecha de publicación: Feb 8 2024

2-3 days in office per week

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 Purpose

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 responsibility as a member of the study team in the design and development of high quality, timely studies (‘end to end’ from Commit to Study to reporting and publication).  This role also contributes to the medical governance and regulatory reporting at the study level by closely collaborating with medical, operations, and regulatory affairs 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.
·  Responsible for development and finalization of study protocols, and amendments of study protocols with appropriate internal/external stakeholder input and consensus while ensuring the protocol fulfills strategic objectives for the asset.
·  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.
·  Provides scientific interpretation of study data.
·  Partners with operations colleagues and matrix study team that all regulatory reporting requirements are met.
·  Co-ordinates with physicians and other study team members to ensure 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/external journal publications, preparation of regulatory documents, and preparation of other relevant study documents.
·  Partners with clinical operations colleagues and other functions to ensure optimal delivery of 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. or Pharm.D.,
·  Two plus years of HIV/antiviral clinical drug development experience contributing to the scientific aspects of clinical program(s) and regulatory submission(s).
·  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)
·  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.
·  two plus years contributing to a team, 3rd parties, academic partners, and subcontracted organizations.

Si necesita una adaptación u otra asistencia para solicitar un trabajo en ViiV, comuníquese con el Centro de Servicios de RR. HH. de ViiV al 1-877-694-7547 (gratis en los EE. UU.) o al +1 801 567 5155 (fuera de los EE. UU.).

ViiV es un empleador que cree en la igualdad de oportunidades y la acción positiva. Todos los solicitantes calificados recibirán la misma consideración para el empleo sin tener en cuenta la raza, el color, el origen nacional, la religión, el sexo, el embarazo, el estado civil, la orientación sexual, la identidad o expresión de género, la edad, la discapacidad, la información genética, el servicio militar, el estado de veterano cubierto o protegido o cualquier otra clase federal, estatal o local protegida.

Aviso importante a las empresas o agencias de empleo

ViiV no acepta recomendaciones de empresas de empleo o agencias de empleo con respecto a las vacantes publicadas en este sitio. Todas las empresas o agencias de empleo están obligadas a ponerse en contacto con el Departamento de Contrataciones Comerciales y Generales o el Departamento de Recursos Humanos de ViiV para obtener autorización previa por escrito antes de recomendar a cualquier candidato a ViiV. La obtención de autorización previa por escrito es una condición precedente a cualquier acuerdo (verbal o escrito) entre la empresa o agencia de empleo y ViiV. En ausencia de dicha autorización por escrito, se considerará que las acciones que emprenda la empresa o agencia de empleo se han realizado sin el consentimiento o el acuerdo contractual de ViiV. Por lo tanto, ViiV no será responsable de ninguna tarifa derivada de tales acciones o cualquier tarifa que surja de cualquier recomendación por parte de las empresas o agencias de empleo con respecto a las vacantes publicadas en este sitio.

Tenga en cuenta que si usted es un profesional de la salud con licencia de EE. UU. o profesional de la salud según lo definido por las leyes del estado que emite su licencia, puede ser necesario que ViiV recolecte e informe los gastos en los que ViiV incurre, en su nombre, en el caso de que se lo entreviste para el empleo. Esta recolección de las transferencias de valor aplicables es necesaria para garantizar el cumplimiento de ViiV con todos los requisitos federales y estatales de Transparencia de los Estados Unidos. Para obtener más información, visite el sitio de Informe de Transparencia de ViiV For the Record .
We’re moving towards a more sustainable future with our new headquarters. With better public transport links and proximity to world-class science and technology institutions, we’re excited for our move to the vicinity of Earnshaw Street, London WC1A (“the New HQ”) by end H1 2024.