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Clinical Development Manager

Brentford

Job Type

Job Function

Medical and Clinical

Location

Brentford

On-Site or Remote

Job Type

Salary

Competitive salary and benefits

About the Role

*Job description* *Site Name:* GSK House *Posted Date:* 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. #LI-GSK #LI-ViiV *Why Us?* 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. ViiV is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. *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 ViiV's 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 ViiV. 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 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 ViiV's compliance to all federal and state US Transparency requirements. For more information, please visit ViiV's Transparency Reporting For the Record site. 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.

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