ViiV (GSK) Director, Epidemiology & Real World Evidence

2 weeks ago

Durham, United States 10480 ViiV Healthcare Company Full time

ViiV Healthcare is an independent, global specialist HIV company with a broad portfolio of antiretroviral medicines, an industry-leading pipeline, and several first-of-their-kind programmes to improve access to medicines and support novel on-the-ground community initiatives. ViiV Healthcare has established presence in 16 countries and we are uniquely positioned to be at the forefront of advancing HIV treatment, care, prevention and cure because we are the only pharmaceutical company 100% focused on HIV.

Through our focus on patient-centered innovation we have developed a strong portfolio of medicines that are advancing treatment and care for people living with HIV around the world. Our broad product portfolio includes a range of therapeutic options throughout the treatment spectrum. The primary focus is on the growth portfolio namely dolutegravir and cabotegravir based regimens as well as other assets and asset combinations from phase IIb through to in-market such as Tivicay, Triumeq as well as Juluca, Dovato, CAB/RPV, CAB prevention, fostemsavir, Maturation Inhibitors and other novel agents early in development pipeline.

The Director, Epidemiology & Real-World Evidence reports to VP, Global Head of Epidemiology & Real World Evidence. Working in a fast paced and dynamic environment you will develop and execute epidemiology and RWE strategy to meet the safety and effectiveness needs of our products across an expanding portfolio. In achieving this you will partner with senior leaders and colleagues across R&D, Safety, Medical Affairs, and Commercial to identify the evidence needs and design and deliver appropriate studies. You will also be involved in collaborations with academic partners, NGOs and public health bodies as well as contract research organisations as needed.

The Director will be based out of ViiV's US Headquarters in Durham, NC (Cary/Wake Forest/Chapel Hill/Raleigh area) OR our International Headquarters in London, UK & is eligible for a relocation package within the US &/or UK.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

Work with Head of Epidemiology & Real World Evidence to develop product specific epidemiology strategy and conduct research studies to accomplish that strategy for ViiV Healthcare portfolio. Set the scientific direction for safety studies conducted by epidemiology; Develop and review protocols. Provide epidemiologic consultation to the product development, safety and medical affairs teams, contributing to the integrated evidence plans for ViiV assets. Lead the planning, documentation and dissemination of the Epidemiology and Real World Evidence strategy for multiple pipeline ViiV assets and development programs; Initiate and co-ordinate epidemiology studies within the strategy; Identify and co-ordinate resources needed to attain project and study timelines. Negotiate research agenda and scope of the studies with regulatory agencies and present company position on disease burden and drug effectiveness/safety at external meetings to ensure medical and commercial impact Differentiates ViiV Healthcare products from the therapeutic alternatives by identifying opportunities in the disease features and its treatments. Identify new opportunities, new methods, or new partnerships with external groups to meet ViiV Healthcare needs; Create or select tools and methodologies to achieve the strategic epidemiologic plan. Contribute to development and delivery of objectives of Global Epidemiology and Real World Evidence and Global Medical Sciences.

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

Ph.D. OR DrPH OR ScD in Epidemiology/Public Health & 3 plus years of post-graduate experience in epidemiology Experience in pharmaceutical industry OR academia OR public health Experience in the practical application of epidemiologic methods Experience in cross-functional OR matrix team leadership

Preferred Qualifications:

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

Experience interacting and negotiating with regulatory agencies Research experience in the HIV/Infectious Diseases field Experience in conducting pharmaco-epidemiology studies Familiarity with regulatory and healthcare compliance guidelines/policies Demonstrated scientific leadership through conference presentations and publications in scientific journals Experience with real world evidence projects, including working with electronic health records, claims data and/or registries Ability to balance multiple and complex tasks, and effectively perform in a matrix environment

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