Physician Senior Director
Site Name: UK - London - Brentford, USA - North Carolina - Research Triangle Park Posted Date: Jul 18 2021 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 be 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 Early Development Focus Physician Senior 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 focus on long-acting medicines. As the Senior Director, 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 the other project physicians and key leaders in virology, pharmacology, biostatistics, and discovery science on the 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 academic universities, and other research collaboratives to ensure ethical and effective delivery of clinical studies. Job Purpose and Key Responsibilities: Design and delivering the plans for early development (working with the Early Development Leader and other executive leaders), including confirmation of the data required to support development of multiple early stage compounds Provide leadership at project level to ensure accuracy, quality and timeliness delivery of the plans for early development and clinical components of required regulatory submissions Ensures high quality protocols are developed and executed to effectively determine a medicine's potential efficacy, safety profile, key areas of product differentiation and value to patient in the shortest possible timeframe Ensures study protocol, Clinical Study Report and other documents reflect input from internal and external experts/thought leaders Ensures the accuracy and scientific integrity of Clinical input to Regulatory documents throughout the lifecycle (including development and post-approval periods) Leads and works with Clinical Scientific Leaders (CSLs) to build and manage External Expert and medical networks Contribute to study protocol development Contribute to the development of the supplementary study documents, manuals, and analysis plans. including but not limited to study procedures manual, reporting and analysis plan, protocol deviation management plan, 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, interacting directly with leading investigators and their study teams 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. Liaise with external collaborators regarding conduct of their studies, e.g. regarding safety events of interest Accountability: Accountable for clinical development activities at medical governance groups and regulatory reporting at the project level including interpretation of data from other functions that might impact safety and efficacy Accountable for the Clinical activities within the project in order to demonstrate a medicine's potential efficacy, safety profile, reimbursability, and value to patients/the company in a timely manner Accountable for Medical Governance across the early stage project to ensure scientific integrity and overall safety of the study subjects across all early stage studies and other company activities/functions impacting safety and efficacy (e.g. Manufacturing, formulation etc.) Evaluation of safety event reports, including SAE, adverse events and laboratory values of concern and the escalation of safety event reports in a timely manner Synthesize and present SAE information and evaluations to the relevant safety oversight boards Synthesize and communicate output of safety oversight boards 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 relevant sections 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 as required Provide training in subject protocol-defined safety parameters and toxicity management to internal and external study team members Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Physician with clinical fellowship in Infectious Diseases OR experience in clinical development and/or clinical trials execution in Infectious Diseases 5+ plus years of drug development OR community clinical trials experience Experience in clinical trials from concept study idea to study initiation to data analysis to publication Early drug development experience including experience with discovery processes, toxicology, drug metabolism and pharmacokinetics, IND enabling study requirements OR clinical pharmacology studies Preferred Qualifications: If you have the following characteristics, it would be a plus: MD/PhD Effective communication skills Good interpersonal relationship building/maintenance Excellent leadership experience in a matrix environment Expertise in HIV drug development Why ViiV Healthcare? 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: Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigor and risk. Managing individual and team performance. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Implementing change initiatives and leading change. Sustaining energy and well-being, building resilience in teams. Continuously looking for opportunities to learn, build skills and share learning both internally and externally. Developing people and building a talent pipeline. Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation. Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally. Budgeting and forecasting, commercial and financial acumen. If you require an accommodation or other assistance to apply for a job at ViiV, please contact the ViiV Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). ViiV is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that 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. 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