Clinical and Epidemiology Project Lead (Senior Director) Chronic Hepatitis B Therapeutic Vaccine

工作内容

Site Name: Italy - Siena, UK - London - Brentford, Belgium-Wavre
Posted Date: Jul 23 2021

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.

GSK Vaccines is looking for a Senior Director to be accountable for the Clinical and Epidemiology strategy of our Therapeutic Vaccine against Chronic Hepatitis B.

Your Responsibilities

• Development, execution, and oversight of Phase I through IV clinical and epidemiological studies, including the integration of global considerations into strategic decisions.
• Ensures the alignment of the Clinical and Epidemiology Plan (CEP) with the overall product strategy.
• Works in collaboration with the Head of Clinical RDC to ensure high scientific rigor and quality of design in clinical and epidemiology studies.
• Ensures that the protocols, reports, publications and clinical regulatory documents are of highest scientific, operational and ethical standards and are completed in time and on budget.
• Collaborates with Quality and Compliance to ensure high quality execution of the clinical and epidemiology studies
• Accountable for the medical and human safety aspects of the clinical and epidemiology programs.
• Manages a 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, clinical/ epidemiology study report finalization, etc, in compliance with Good Clinical Practice and GSK policies and procedures.
• Supports cross-functional partners as necessary for activities including External Expert engagement and PI selection.
• Serves as the Clinical or Epidemiology 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 serves 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 Clinical and Epi R&D Excellence Lead and Asset Lead, ensuring milestones delivery and resource optimization.
• Represents the Clinical and Epidemiology functions at the Vaccine Development Team, Vaccine Commercial team, and Discovery Project Teams, as applicable. Supports these teams 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. Serves as the primary clinical and epidemiology for the project at governing bodies such as Research Board, Development Review Board, Vaccine Investment Board and technical committees such as Vaccine Safety Management Board, Protocol Review Board and Toxicology Working Group.
• Collaborates 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.
• Manages a team of up to12 CRDLs and Epidemiologists, and maintains oversight and strategic intent of the program. Ensures effective coaching and mentorship of more junior members of the clinical and epidemiology team.
• Core member of the Clinical R&D, RDC Belgium Leadership Team.
  
  

Why you?

Basic Qualifications

• MD with the ability to independently conduct clinical and epidemiology research.
• Previous experience in pharmaceutical industry is required, specifically 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.
  
  

Preferred Qualifications

• Previous experience in the field of infectious diseases, and /or immunology/immunotherapy
• 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: 31 July 2021

Why GSK?

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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