ViiV Healthcare Clinical Director

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.

ViiV Healthcare was created as a joint venture by Pfizer and GlaxoSmithKline in November 2009 with both companies transferring their HIV assets to the new company. In 2012 Shionogi joined the company. 76.5% of the company is now owned by GlaxoSmithKline, 13.5% by Pfizer and 10% by Shionogi.

The Clinical Director, Mature Marketed Products (MMPs) at ViiV HC will provide scientific leadership, direction and strategy as part of the MMP Team.  One of the primary activities Is developing, implementing and supporting the lifecycle management activities and reports for ViiV Healthcare Mature Marketed Products.  This includes serving as a clinical point of contact for senior management and senior level matrix teams (Regulatory, Safety, Clinical Pharmacology and others), both internally and externally (Health Authorities, Research Organisations and others).  To accomplish this, it is critical to build and maintain networks and lines of communication to ensure quality and timely lifecycle management for ViiV Healthcare MMPs.

Knowledge of the drug development cycle and the lifecycle management for ViiV Healthcare Mature Marketed Products is critical, including knowledge of related drug development disciplines e.g. preclinical, drug supplies, regulatory, clinical safety to enable multidisciplinary approaches to be identified and integrated to enable cohesive lifecycle management.

Excellent written and oral communication skills are essential for the writing and review of regulatory and safety documents, occasionally supporting research reports as well. This often includes assisting with regulatory interactions including the drafting of clinical responses to health authority questions and requests. It is important to communicate confidently and effectively both internally and externally with capability of adapting messages for different audiences, including non-native English speakers.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…

• Designs, develops, implements and supports the lifecycle management activities for ViiV Healthcare Mature Marketed Products.
• Provide mentoring and coaching for matrix team members
• Serve as a clinical point of contact for senior management and senior level matrix teams, both internally and externally
• Represent ViiV Healthcare effectively in relationship building and due diligence and negotiations with external organizations, including academic institutions, vendors and CROs
• Lead the writing and the review of safety and regulatory documents. Assist with regulatory interactions such as drafting Clinical responses to RTQs and RSIs
• Proactively identify business issues/risks; propose and implement strategies to manage implications and risks on business/clinical program timelines, budgets and goals
• Develop and implement solutions for overall lifecycle management plan problems
• Make decisions which balance risk/benefit with clear understanding of impact across projects and therapeutic area; ensure action taken to mitigate risk where appropr