Job title: Scientific Director and Antibiotic Susceptibility Program Lead, Infectious Diseases Medical & Scientific Affairs
Company: GlaxoSmithKline
Job description: Job Description : Site Name: UK – London – Brentford, GSK Asia House, India – Maharashtra – Worli Mumbai Posted Date: Jun 29 2022 Scientific Director and Antibiotic Susceptibility Program Lead, Infectious Diseases Medical & Scientific Affairs As a s
Job Description : Site Name: UK – London – Brentford, GSK Asia House, India – Maharashtra – Worli Mumbai Posted Date: Jun 29 2022 Scientific Director and Antibiotic Susceptibility Program Lead, Infectious Diseases Medical & Scientific Affairs As a scientist or physician with a track record of success in either a relevant clinical/academic field or within the pharmaceutical industry (ideally both), are you interested in a highly visible leadership role that allows you to lead a study program and elements of global medical affairs delivery while partnering with internal and external stakeholders If so, this Scientific Director and Surveillance Program Lead, Infectious Diseases Medical & Scientific Affairs is an exciting move to explore. We are seeking a highly motivated Scientist and Scientific/Medical Affairs professional to lead the long-running Survey of Antibiotic Resistance (SOAR) program and drive engagement and communication around antibiotic surveillance, antibiotic stewardship and the need to tackle the increasing threat of Antimicrobial Resistance (AMR). The role: The Scientific Director and Antibiotic Susceptibility Program Lead works within the General Medicines Global Medical and Scientific Affairs team, to lead the SOAR program and embed the scientific insights and strategic advice on microbiology aspects into the medical strategy – supporting Appropriate Antibiotic Prescribing (AAP) and tackling Antimicrobial Resistance (AMR) and informing the life-cycle management of Augmentin and the marketed infectious disease portfolio. Scientists/physicians appointed at this grade will be expected to operate competently across the breadth of the role. Key responsibilities: Lead the SOAR program, as study accountable person, antibiotic surveillance and clinical microbiology expert. Input to the design and delivery of other evidence generation studies and advise on local susceptibility studies and data collection. Develop relationships with key opinion leaders and academic researchers, in accordance with GSK Scientific Engagement Guidelines, to assist with the development and study of the marketed infectious disease portfolio and support the profile of GSK in supporting Appropriate Antibiotic Prescribing (AAP) and tackling Antimicrobial Resistance (AMR). Provide scientific insights and strategic advice on microbiology aspects to shape the integrated evidence strategy and medical plan and support progression and life-cycle management of Augmentin and the marketed infectious disease portfolio. Present data and scientific information internally and externally and be able to answer questions relevant to SOAR, antibiotic surveillance and AMR. Represent GSK as appropriate in external forums and organizations supporting AAP and tackling AMR. Develop and review publications/abstracts/posters related to the SOAR and surveillance study program, covering susceptibility, antibiotic stewardship and AMR. Ensure the publication Data Dissemination Plan (DDP) is maintained in Datavision and co-create medical-commercial DDP. Support preparation of relevant materials for the Brand & Medical Planning (MP) processes. Lead/contribute to designated elements of the above-country MP e.g. Advisory Boards Symposia. Input to relevant aspects of promotional campaigns and materials, in compliance with all relevant codes and system requirements. High level of responsibility for the successful delivery of critical projects with high quality and processes, including overcoming challenges, focusing on what matters, and execution. Study and activity budgeting and cost-consciousness. Work with Global Clinical Operations Leadership Team and assigned Global Process Owner(s) and a broad range of stakeholders to ensure that SOAR is integrated into the Clinical Operations new ways of working and that processes are fully understood and effectively implemented. Support the implementation of new ways of working and Internal Control framework and ensure the execution of operations. Ensure that any feedback or findings from Town Halls, Focus Groups, Surveys, Audits, Independent Business Monitoring Assessments & Regulatory Inspections impacting of working and processes are analyzed for root cause and that fit for purpose, realistic, clear, and timely communications and engagements are created and implemented. Support the writing/compilation/review of regulatory reports and microbiology sections of regulatory submission documents. Why You Basic Qualifications: Bachelors’ Degree in Scientific or related discipline. Knowledge of microbiology and antibacterial drug development. Experience in leading and implementing centrally led antibiotic surveillance studies. Understanding of drug development process and GCP principles. Experience in Medical Affairs and life cycle management. Demonstrated capability to work effectively individually, in fast-paced team/matrix environments and in collaboration with external experts. Preferred Qualifications: Advanced Degree, PhD and postdoctoral research in microbiology, or MD. Proactive and highly self-motivated self-starter with strong strategic thinking skills. Outstanding written and oral communication skills. Demonstrated ability to build strong networks of external and internal experts Experience in designing, monitoring or conducting antibacterial surveillance studies. Knowledge of susceptibility testing methodology including CLSI/EUCAST procedures and guidelines. Knowledge of the criteria used in setting antimicrobial breakpoints. Understanding of pharmaceutical codes/regulations previous involvement in review and approval processes. 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. .LIGSK As a company driven by our values of Patient focus, Transparency, Respect and Integrity, we know inclusion and diversity are essential for us to be able to succeed. We want all our colleagues to thrive at GSK bringing their unique experiences, ensuring they feel good and to keep growing their careers. As a candidate for a role, we want you to feel the same way. As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race/ethnicity, colour, national origin, religion, gender, 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.(.US only). We believe in an agile working culture for all our roles. 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Expected salary:
Location: India
Job date: Fri, 01 Jul 2022 22:50:45 GMT
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