Posted Date: Jun 30 2020
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.
In this Medical Director role, you will have an opportunity to contribute to the goal of leaving no patient behind and striving for new treatment options for people living with HIV with a particular focus on pediatrics. As the Pediatric Clinical Trial Director working on clinical trials, you will be responsible for medical governance for Phase 1-4 studies, providing your medical perspective on overall study conduct and procedures, and working closely with study scientists and the lead project physician on interpretation and reporting of clinical study data & results. In addition, a key part of this role will be creating and maintaining effective working relationships both within ViiV & GSK, as well as with external project collaborators such as the NIH to ensure ethical and effective delivery of clinical studies.
Job Purpose and Key Responsibilities:
- Contribute to study protocol development
- Contribute to the development of the annex documents, including but not limited to study procedures manual (SPM), reporting and analysis plan (RAP), protocol deviation management plan (PDMP), etc.
- Contribute to the development of responses to regulatory authority’s queries regarding clinical studies
- Support the clinical scientists in the preparation of answers to local Institute Review Board (IRB)/Ethic Review Committee (ERC) questions
- Address medical issues and concerns that arise during the study feasibility assessment
- Provide medical perspective on overall study conduct, procedures and management of safety events to clinical study team
- Liaise, with the collaborator study teams, sites and/or investigators to obtain all necessary documentation to assist the Safety Review Team (SRT) and/or safety physician/scientist with establishment of medical details and causality/expectedness of SAE/death
- Liaise with external collaborators regarding conduct of their studies, e.g. regarding safety events of interest
- Evaluation of safety event reports, including SAE, adverse events (AE) and laboratory values of concern
- Escalate safety event reports in a timely manner
- Present SAE information and evaluations to the relevant safety oversight boards such as, but not limited to, SRT and VSLC
- Communicate output of safety oversight board to collaborators, sites and/or CRO, if applicable e.g. restart after liver-stopping criteria
- Provide guidance regarding protocol-related medical issues to collaborators, sites and/or CRO in a timely manner
- Provide review and approval of study protocol and risks section of ICF
- Ensure electronic protocol inquiries and site interactions, inclusive of safety events and other study-related matters are filed in the study electronic TMF (eTMF) as required
- Provide training in subject protocol-defined safety parameters and toxicity management to internal and external study team members
We are looking for professionals with these required skills to achieve our goals:
- Physician (MD or equivalent), with clinical fellowship in Infectious Diseases and/or experience in clinical development and/or clinical trials execution in Infectious Diseases
- 2 plus years of drug development or clinical trials experience
- Experience in running clinical trial from concept study idea to publication
If you have the following characteristics, it would be a plus:
- Effective communication skills
- Good interpersonal relationship building/maintenance
- Excellent leadership experience in a matrix environment
- Expertise in HIV drug development
Our values and expectations are at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
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