Sr Clinical & Research Development Lead, RSV
Site Name: USA - Maryland - Rockville, Belgium-Wavre, Italy - Siena Posted Date: Nov 9 2021 Innovation is the beating heart of our business. Without it, there will be no new vaccines for the many diseases that still threaten individuals, families and communities around the world. Our Vaccines scientists work in three global R&D centres, in Belgium, Italy and the US - and a fourth virtual R&D centre dedicated to mRNA technology. We are focused on discovering and developing novel vaccines across a range of pressing public health threats. Our efforts are concentrated on those possible vaccines which may offer significant improvements over existing options or target diseases for which no vaccines yet exist. Our approach is to make the most of our own expertise and experience, while at the same time forming complementary partnerships and alliances with others who bring different kinds of expertise. Our vision for the world, where everyone has access to the vaccines they need, depends on a steady supply of great ideas and brilliant science. We have much to offer and through collaboration we can achieve so much more. We currently have an opportunity for Sr Clinical & Development Research Lead/Clinical Development Director to join our RSV team. Reporting to the Clinical and Epidemiology Research & Development Project Lead (CEPL) you will conduct Phase I-IV Clinical Development activities within a large program or group of related programs or, for a mid-size program, to lead Clinical Development activities in order to ensure the high quality and on-time delivery of all clinical data that will allow world-wide registration in compliance with the clinical development plan, good clinical practices (GCP), and GSK Vaccines standard operating procedures (SOP). Key responsibilities: Where applicable, lead 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. Ensure consistency of data within program and across projects. Reporting accountability will be to Clinical and Epidemiology Research & Development Project Lead (CEPL). Responsible for the clinical portion of file submission and its registration process, under the leadership and direction of the CEPL. Bear 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. 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 If applicable, represent clinical development within Vaccine Commercialization Team (VCT), Discovery Performance Unit (DPU), Protocol Review Board (PRB), Toxicology Working Group (TWG), etc. If appropriate, support the CEPL or serve as delegate of the CEPL as the principal liaison to Independent Data Monitoring Committee (IDMC). Serves as a scientific and management reference for the project (internally/externally) Supports 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 teams, and serve 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 Supports the clinical team to consistently achieve high standards in attainment of project timelines in global programs. Interfaces with the PDL to ensure milestone realization and resource optimization. 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) Support or leads one Clinical Project team (matrix teams including, but not limited to, CRDL's, Science Writers, Biostatistics, Study Delivery Leads, and Study Data Managers) with a spirit of creativity and instills optimism and a can-do attitude. Provides formal feedback, which encourages team member develop their skills. Provides performance feedback on matrix team members to responsible line managers. Enhances the knowledge level of the entire team by developing project-specific training programs. Consistently displays creative and innovative leadership skills while working in a matrix team. Provides support to Marketing/Business Development throughout product life cycle Contribute to the clinical components of "Due Diligence" and other clinical activities in support of Business Development as applicable. Provide medical support to Marketing in order to achieve Company's objectives. Actively follows-up the product-related Environment Responsible for follow-up of project related literature, discussions with external experts and authors, participation in congresses and presenting GSK data. Reviews and approves labeling and related promotional materials where applicable. People management Contributes to provide leadership, direction and vision for the team. Provides input and participate in the recruitment and development of the team of Clinical Research & Developmen Leads. Build and foster the establishment of a CRDL community. 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 or PhD Ability to independently research questions; sound scientific background required to critically evaluate all scientific aspects of vaccinology / immunology / medicine development. Minimum 3 years industry experience or minimum 10 years of experience working in a scientific or medical institution including regulatory agency. Good theoretical and practical knowledge in clinical research. Ability to translate scientific skills in the field of vaccines and clinical research into business-driven strategies. Knowledge and understanding of vaccines, clinical research, translational science, and biomedical research regulation, including ICH and GCP. Ability to work well within a matrix environment, balance priorities, and handle multiple tasks through good planning, project administration, and organization skills. Effective ability to prioritize tasks and deliver on deadlines, with high performance standards and a commitment to excellence. Knowledge and understanding of causes of infectious diseases, health interventions and the global public health landscape. Needs to possess highly effective communication skills and be capable of presenting ideas and data clearly to various audiences Excellent knowledge of spoken and written English Preferred Qualifications: License to practice medicine and board and/ or professional certification is an asset. Previous vaccinology experience highly desirable Experience in leading or supporting a biologics license application or major sBLA Why GSK? Every day, we help improve the health of millions of people around the world by discovering, developing and manufacturing innovative medicines, vaccines and consumer healthcare products. We are building a stronger purpose and performance culture underpinned by our values and expectations - so that together we can deliver extraordinary impact for patients and consumers and make GSK a brilliant place to work. Our values are Patient focus, Transparency, Respect, Integrity. Our expectations are Courage, Accountability, Development, Teamwork. *LI-GSK #IDPhysicians Closing date for applications: 30th November 2021 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. 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