Site Name: USA - Maryland - Rockville Posted Date: May 12 2022 Our vaccines R&D efforts are centred around discovering and developing prophylactic and therapeutic vaccines to protect people against infectious diseases. With a cutting-edge range of technologies and brilliant scientific minds, we are driving the development of new vaccines to address unmet medical needs We currently have an opportunity for Sr Clinical Research & Development Lead/Clinical Development Director to join our Early Development team. Reporting to the Clinical and Epidemiology Research & Development Project Lead (CEPL), you will have the opportunity to lead a matrix team, to author clinical development plans, design clinical trial protocols, and author clinical study reports and publications of high scientific, operational and ethical standards, ensuring consistency of data within program and across projects. You will be responsible for the clinical portion of file submission and its registration process, under the leadership and direction of the CEPL, taking primary responsibility and accountability for scientific and medical quality and timeliness of clinical trial synopses and protocols and all clinical trial documents, including the Investigator's Brochure and the Clinical Study Report. Key responsibilities: Where applicable, support or act as the delegate of the Clinical and Epidemiology Research & Development Project Lead in representing GSK Vaccines in meetings with health authorities and the scientific community, net-work with thought leaders and international agencies as needed. You will also have the opportunity to represent clinical development within Vaccine Commercialization Team, Discovery Performance Unit, Protocol Review Board, and Toxicology Working Group . You will support internal process improvement activities and initiatives involving coordination of multidisciplinary working team across departments (clinical, safety, regulatory) and maintains contacts with internal and external stakeholders (e.g., Brighton collaboration working group, CDC, and others). Assumes accountability for the medical/legal and human safety aspects of the clinical program (if not an MD, assembles and transmits timely summaries of clinical safety data for review by competent medical officer). Responsibility for Data Listing review for the medical portion of data listing for individual studies, assure medical consistency within trial and across trials within program. Address scientific and medical issues related to one or more projects. Pay special attention to serious adverse events occurring during clinical trials and potential safety signals. Liaise with safety and pharmacovigilance department to develop Risk Management Plans (RMPs), Periodic Benefit Risk Evaluation Report (PBRER), Global Safety Data sheets, Development Safety Updated reports (DSUR), and Periodic Safety Updated Reports (PSUR) and serves on SRT (Safety Review Team), on clinical program level accountable for. In clinical programs, together with PV analyze safety and potential signals and escalate accordingly. Publishes clinical data in peer review journals and presents in external scientific meetings / congresses. Maintains and expands knowledge in medical and scientific competencies (as appropriate), vaccinology and trial methodology. Budget, resourcing and timing Liaise with the Regional Evidence Generation team to ensure alignment of clinical trial activities (includes but not limited to, scientific and medical issues as well as subjects' safety). Supports or Leads the Clinical Project Team(s) with a spirit of creativity and instills optimism and a can-do attitude Contribute to the clinical components of "Due Diligence" and other clinical activities in support of Business Development as applicable. People management; contributes to provide leadership, direction and vision for the team of CRDL function, serves as mentor in line / matrix reporting setting with an active interest in the leadership and technical development of team members. Why you? Basic Qualifications: MD and/or PhD 3 plus years of vaccine industry experience OR 10 plus years of clinical research experience working in a scientific, medical institution, or industry Experience in translating scientific skills in the field of vaccines and clinical research into business-driven strategies. Experience in GCP and ICH guidelines & working with Regulatory functions (i.e. filing IND, BLA, CTD) Preferred Qualifications: Specialism in the field of pediatrics, infectious diseases, clinical epidemiology, or pharmacoepidemiology. Previous experience in clinical vaccinology is an asset. Knowledge and understanding of vaccines, clinical research, translational science, and biomedical research regulation, including ICH and GCP. Knowledge and understanding of causes of infectious diseases, health interventions and the global public health landscape. Sensitivity to the needs of a diversified ethnic groups and ability to build rapport across the spectrum. Strategic thinking skills and achievement oriented. Able to critically analyse information, identify strengths and weaknesses of approaches and develop remedial actions to mitigate risks. Ability to understand high level corporate and business objectives: rapid, flexible, innovative working and decision making. Needs to possess highly effective communication skills and be capable of presenting ideas and data clearly to various audiences . License to practice medicine and board and/ or professional certification is an asset Why GSK? We are one of the world's largest vaccines companies, delivering vaccines that help protect people at all stages of life. Our R&D focuses on developing vaccines against infectious diseases that combine high medical need and strong market potential. Our Vaccines business has a portfolio of more than 20 vaccines to help protect people from a range of diseases throughout their lives. We supply these vaccines to people living in over 160 countries. The business generated sales of £7 billion in 2020. *LI-GSK #IDPhysicians Relocation support and flexible work locations available. Closing date for applications: 20 June 2022 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). GSK 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 GSK, 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. GSK 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 GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. 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