Head - Safety Science & Research, Epidemiology and Patient-Centered Outcomes (PCO)

Site Name: USA - Pennsylvania - Upper Providence, Home Worker - GBR, UK - Hertfordshire - Stevenage, UK - London - Brentford, USA - Pennsylvania - Philadelphia Posted Date: May 6 2022 Although advertised in Upper Providence, US, we will consider candidates at other locations through the US and UK, including home-workers. As Head (Senior Director) of Safety Science and Research for the Epidemiology and PCO group (part of Value Evidence and Outcomes (VEO) within R&D) you will be responsible for 1) managing the strategic input and oversight of epidemiology into safety and risk management programs, including the R&D pipeline and marketed portfolio and 2) providing epidemiologic and real-world analytic support to the Human Genetics and Discovery Medicine functions within GSK's Research organization. In this role you will be accountable for promoting best practice and innovation in the use of epidemiology, RWD and advanced analytics for safety and risk management, including patient-reported or clinician-observed outcomes; ensuring the Epidemiology group meets its key metrics in support of Safety Review Teams; representing the VEO function at GSK's Global Safety Board and the Global Safety Leadership Team; and developing and executing early epidemiology evidence plans to support key Research assets. This is an opportunity to join a large epidemiology group within a major pharma company, fitting into an integrated VEO organisation which allies the disparate functions of PCO, Safety and more. As such, there is fantastic opportunity for lateral growth and to expand the breadth of your knowledge from this position. You will be working directly with senior leaders in safety, but also will be closely engaged with an extremely innovative research and development organisation inside GSK. Details (Your Responsibilities): This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following… Safety Science Working directly with the Head of Epidemiology, Epidemiology TA Heads, Head of Safety, and Safety Evaluation and Risk Management (SERM) TA Heads and other stakeholders to: Understand and influence development of safety and risk management strategies for assets Evaluate the key benefit risk knowledge gaps and use influence to ensure Epidemiologists translate gaps into epidemiology programs tailored to asset needs and these are reflected at the Safety Review Team Champion prioritization of projects that contextualize safety using RWD and optimally plan for post-marketing activities as part of Integrated Evidence Plans Effectively communicate and advocate for an enterprise-wide, and when appropriate TA specific, framework for safety epidemiology contributions and innovation, including the management of Post-Authorization Safety Studies (PASS) and Targeted Safety Studies (TSS) Managing a team including the Senior Director, Classic and Established Products and Vulnerable Populations Lead To liaise with key local operating companies (Japan, China, Korea, and others when applicable) to ensure global Epidemiology input to national pharmacovigilance activities Representing VEO on GSK's Global Safety Board serving as senior most epidemiologist in safety governance, ensuring epidemiology and RWD are applied appropriately in support of pharmacovigilance activities Representing the Epidemiology function, particularly as it relates to pharmacovigilance, externally in regulatory inspections and meetings, public-private partnerships and at scientific societies Representing the Epidemiology function at the Global Safety Leadership Team To partner with Non-Interventional Study (NIS) Global Business Owner and Head of PV Excellence to ensure regulatory guidance for risk management related NIS are effectively embedded within relevant GSK processes Research To partner with key stakeholders in Human Genetics and Discovery Medicine functions to prioritize epidemiologic support to early assets Managing a group of 2-4 epidemiologists to develop and execute early epidemiology evidence plans in support of key Research assets Leading resourcing strategy; provide guidance and support to each team member on their development of the specific disease & early asset support strategy, work priorities, and delivery; conduct scientific review and governance of team members' work output; discuss and agree performance and development objectives. To provide advice and guidance for best practice in epidemiology evidence generation strategies and methodologies, including enabling internal and external scientific advice to the Research organization General You'll serve on the Epidemiology and PCO Leadership Team and lead departmental and divisional initiatives to continuously improve operations and advance innovative science and analytics Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Doctorate in epidemiology 10 + years' experience conducting pharmacoepidemiologic research in support of clinical development and post-approval 10 + years' experience providing oversight to Post-Authorization Safety Studies with a strong understanding of regulations and regulatory guidance Line management experience, specifically coaching and developing junior members of the group. Demonstrated leadership and strategic excellence. Experience of complex problem solving through resourceful use of information and contacts. Experience leading partnerships with R&D functions Experience of regulations relevant to application of epidemiology to clinical development and safety Experience in leadership roles for scientific organizations, cross-industry activities and/or public-private partnerships Preferred Qualifications: If you have the following characteristics, it would be a plus: Experience in regulatory inspections of sponsors by EMA and/or FDA Experience in application of observational scientific methods to other domains, such as to benefit-risk assessments, patient-preference studies, or similar Excellent communication skills to interact effectively in multi-disciplinary matrix teams and to influence global stakeholders and key opinion leaders. Ability to provide constructive feedback to direct reports or junior staff on methodological or team issues. Self-motivated with the ability to work independently to develop credibility with colleagues within and outside Epidemiology. Ability to work well within a business-driven environment, establish cross-functional relationships, balance priorities and handle multiple tasks through good planning, project administration, and organization skills Why GSK? At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Health, strengthening our leadership, and transforming our commercial execution. Now, we're making the biggest 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. *LI-GSK If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). 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