Senior Clinical Development Research Director (SCRDL)
Our breakthrough shingles vaccine, was approved for the prevention of shingles in adults aged over 50 by the FDA in October 2017, and by the European Commission in March 2018, and was recognized as the most successful biopharma launch in the past 10 years in North America. Today, this vaccine has become the gold standard for shingles prevention with unprecedented high efficacy of >90%, with proven 4-year duration of protection.
As part of the Vaccines R&D Group, we are currently looking for a Senior Clinical Development Director to join this critical 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.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, ensuring consistency of data within program and across projects.
- 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
- 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.
- 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.
- 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 & Development 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.
- MD with ability to independently research questions; sound scientific background required to critically evaluate all scientific aspects of vaccinology / immunology.
- Minimum 3 years industry experience or minimum 10 years of experience working in a scientific or medical institution.
- 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
- License to practice medicine and board and/ or professional certification is an asset.
- Previous vaccinology experience highly desirable.
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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.
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