Clinical and Epidemiology Project Lead, Therapeutic Hepatitis B Vaccine Open to flexible working
Patient-focused Research and Development (R&D) is the heart of our business. GSK has a strong history and expertise in vaccines, and we are staying at the forefront of innovation in this field. For many years, vaccines have been used mainly to prevent diseases caused by infections, mostly in infants and children. Today, we are focused on developing vaccines for all stages of life, and we believe vaccines can also be used successfully to treat diseases and be therapeutic.
These innovation trends have a strong impact on what we do in Research and Development. We take the best science, with the most impactful technologies and combine it with our GSK culture. Next to our existing portfolio of prophylactic vaccines and moving into the field of therapeutic vaccines, our R&D programme focuses on vaccines for diseases such as RSV, COPD and Meningitis. Another part of R&D targets diseases particularly prevalent in the developing world, including the World Health Organisation's priority diseases - tuberculosis and malaria.
Working from one of global R&D hubs: Rixensart, Belgium or Siena, Italy, a s the Clinical and Epidemiology Project Lead you will lead the Clinical and Epidemiology Program(s) (CEPs) for our Therapeutic Hepatitis B Vaccine. Accountable for the development, execution, and oversight of Phase I through IV clinical and epidemiological studies, including the integration of global considerations into strategic decisions, you will ensure alignment of the CEP with the Global Regulatory Plan, Medical Plan, and overall strategic product development. You will work in collaboration with the Head of Clinical RDC to ensure high scientific rigor and quality of design in clinical and epidemiology studies. As the CEPL, you will be accountable for the medical and human safety aspects of the clinical and epidemiology programs.
- Manage the team of Senior Clinical Research and Development Leads (CRDLs), CRDLs, Senior Epidemiologists, and Epidemiologists assigned to the development program. These individuals are responsible for leading the clinical matrix teams and epidemiology teams responsible for clinical/epidemiology study activities, including protocol development, data cleaning and reconciliation, statistical analysis plans, interfaces with Primary Investigators (PIs), clinical/ epidemiology study report finalization, etc, in compliance with Good Clinical Practice (GCP) and GSK policies and procedures.
- Support cross-functional partners as necessary for activities including External Expert (EE) engagement and PI selection. Serve as the Global Accountable Person (GAP) for Investigator-Sponsored Studies (ISS) associated with the given development program. Support the regional Medical Affairs and Epidemiology teams as needed.
- Serve as the Sponsor Signatory for studies within the development program and is accountable for the final analysis and interpretation of clinical and epidemiology trial data. Also accountable for the authorship of clinical documents for regulatory submissions, and serve as the Program Clinical Expert for input into regulatory documents/meeting. Accountable to ensure publication of clinical trial and epidemiology study data according to ICJME and relevant GSK policies and guidelines.
- Accountable for consistently achieving project timelines in global programs with high quality of execution. Participates in key budget/forecast activities in collaboration with Sr. Clinical and Epi R&D Excellence Lead (CEEL), and Asset Lead (Clinical Operations). Interfaces with the CEEL, the Asset Lead and Head of Clinical RDC to ensure milestones realization and resource optimization.
- Represent the Clinical and Epidemiology functions at the Vaccine Development Team (VDT), Vaccine Commercial team (VCT), and Discovery Performance Team (DPT), as applicable. Supports the VDT/VCT/DPT as necessary through provision of thoughtful senior clinical and epidemiology input and technical expertise to global development questions, including contributions to internal and external briefing documents and presentation materials.
- Serve the primary clinical and epidemiology voice for the project at governing bodies such as Development or Research Review Boards (DRB/RRB), Vaccine Investment Board (VIB) and technical committees such as Vaccine Safety Management Board (VSMB), Clinical and Epidemiology Review Forum and Toxicology Working Group (TWG).
- Collaborate with cross-functional partners in Preclinical, Technical Development, the Clinical Operations, Biostatistics, Regulatory Affairs, Medical Affairs, Health Economics, and Commercial to ensure effective delivery of the project according to agreed plans.
- As needed, involved in the development and execution of external collaborations. May be requested to support business development activities, including the performance of due diligence reviews.
- Manage a team of CRDLs and Epidemiologists and maintains oversight and strategic intent of the program. Ensure effective coaching and mentorship of more junior members of the clinical and epidemiology team.
- Core member of the Clinical RDC Leadership Team.
We are looking for professionals with these required skills to achieve our goals:
- Extensive pharma experience in Drug Development
- Breadth of experience in vaccine clinical research, epidemiology or related field, of which at least 5 years of experience in the Industry .
- Extensive knowledge and understanding of vaccines, clinical research, translational science, and biomedical research regulation, including ICH and GCP.
- Excellent people and team management skills.
- Strategic thinking skills and achievement oriented.
- Ability to critically analyze information, identify strengths and weaknesses of approaches and develop remedial actions to mitigate risks.
- Strong leadership, coalition-building and communication skills.
- Excellent knowledge of spoken and written English.
- Ability to work well within a matrix environment, balance priorities, and handle multiple tasks through good planning, project administration, and organization skills.
- Previous experience in the field of infectious diseases, immunology/immunotherapy, clinical epidemiology, pharmacoepidemiology, and/or clinical vaccinology is an asset.
- Executive capability with strategic planning & budget processes
- License to practice medicine and board and/ or professional certification is an asset.
- Effective ability to prioritize tasks and deliver on deadlines, with high performance standards and a commitment to excellence.
Closing date for applications: 30th June 2021
Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork in a culture of Innovation, Performance and Trust.
If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.
Our goal is to be one of the world's most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.
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