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Medical Director, ViiV Healthcare

Company: GlaxoSmithKline
Location: Durham
Posted on: September 12, 2020

Job Description:

USA - North Carolina - Research Triangle Park

UK - London - Brentford

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

Accountability:

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

Why you? Basic Qualifications:

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

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

Good interpersonal relationship building/maintenance

Excellent leadership experience in a matrix environment

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, rigour 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.

*LI-GSK

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.

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. ViiVshall 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.

Posted 2 Days Ago

Full time

256609

About Us We are ViiV Healthcare: 100% dedicated to HIV medicines and research and completely focused on people affected by HIV/AIDS.

ViiV Healthcare was 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. Our one focused goal unites our 1300 employees located across over 20 countries, with their expertise in research, manufacturing, policy and more, all guided by our mission to be here until HIV isn’t.

We will not rest until we leave no person living with HIV (PLHIV) behind. Until the 37 million PLHIV is down to zero, we will continue searching for new ways to limit the impact of HIV.

Keywords: GlaxoSmithKline, Durham , Medical Director, ViiV Healthcare, Other , Durham, North Carolina

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