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Director, Epidemiology Real World Evidence

Research Triangle Park, North Carolina; Research Triangle Park, North Carolina; Philadelphia, Pennsylvania
Closing date
May 20, 2022

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Health Sciences, Medicine
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Site Name: RTP, UK - London - Brentford, USA - North Carolina - Research Triangle Park, USA - Pennsylvania - Philadelphia Posted Date: May 4 2022 Director, Epidemiology & Real-World Evidence Location: US RTP Raleigh / Durham North Carolina; UK -London Flexibility: Remote within US East Coast Time Zone - must be willing to travel ViiV Healthcare is an independent, global specialist HIV company combining the HIV expertise of GSK, Pfizer and Shionogi, 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 and care 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 Global Head, 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. Key Responsibilities: 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. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Ph.D. / DrPH /ScD in Epidemiology/Public Health 3 plus years of post-graduate experience in epidemiology or related field Experience in pharmaceutical industry, academia and/public health Experience in the practical application of epidemiologic methods in the specialized field of pharmacoepidemiology Experience in cross-functional 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 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 Interested in Joining the Team? Please apply via our online portal providing your CV and Cover Letter. (Please take a personal copy of the Job Description, as this will not be available online post closure of the advert) Closing Date: 22nd May 2022 *LI-GSK Why GSK? At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Healthcare, strengthening our leadership, and transforming our commercial execution. Now, we're making the most significant changes we've made to our business in over 20 years. We're on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands. With new ambition comes new purpose. For New GSK, this is to unite science, talent, and technology to get ahead of disease together - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive. Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients - so we deliver what matters better and faster; accountable for impact - with clear ownership of goals and support to succeed; and where we do the right thing. So, if you're ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together. 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. At ViiV, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve. ViiV has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons. 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.
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