The Senior Director, Clinical Development Vaccines - Covid mRNA
will manage a team of Clinical Research and Development Leaders and Epidemiologists, and will be accountable for the delivery of the Global Clinical and Epidemiology Plan (GCEP) for a major vaccine asset in development and/or life cycle management.
The Clinical and Epidemiology Project Lead is 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. Ensures alignment of the GCEP with the Global Regulatory Plan, Medical Plan, and overall strategic product development. Works in collaboration with the Head of Clinical RDC to ensure high scientific rigor and quality of design in clinical and epidemiology studies. Ensures the incorporation of regional input into GCEP. Ensure 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 GCEP. Accountable for the medical and human safety aspects of the clinical and epidemiology programs.KEY RESPONSIBILITIES
• 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.
• Supports cross-functional partners as necessary for activities including External Expert (EE) engagement and PI selection. Serves as the Global Accountable Person (GAP) for Investigator-Sponsored Studies (ISS) associated with the given development program. Supports the regional Medical Affairs and Epidemiology teams as needed.
• 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 the Asset Lead. Interfaces with the Asset Lead and Head of Clinical RDC to ensure milestones realization and resource optimization.
• Represents the Clinical and Epidemiology functions at the Vaccine Development team (VDT). Supports the VDT 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 the primary clinical and epidemiology voice in concert with the Senior Epidemiology Expert for the project at governing bodies such as the Vaccine Life Cycle Management Board, (LCM), Vaccine Investment Board (VIB) and technical committees such as Vaccine Safety Management Board (VSMB), Protocol Review Board (PRB) and Toxicology Working Group (TWG).
• Collaborates with cross-functional partners in the Clinical Evidence Generation Platform, Regulatory Affairs, Medical Affairs, Health Economics, and Commercial to ensure effective delivery of the project according to agreed plans.
• If requested, 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 CRDLs and Epidemiologists, Maintains oversight and strategic intent of the development program. Ensures effective coaching and mentorship of more junior members of the clinical and epidemiology team.
• Core member of the Clinical RDC Leadership Team. Why you? Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
- Experience in clinical development, ideally from PI - IV
- Prior leadership experience in a cross functional matrix team
If you have the following characteristics, it would be a plus:
- MD specializing in the field of pediatrics, internal medicine, infectious diseases, clinical epidemiology, or pharmacoepidemiology. Previous experience in clinical vaccinology is an asset.10 years' experience preferred.
- Extensive 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.
- Proven track record of managing complex programs.
- Sensitivity to the needs of a diversified ethnic groups and ability to build rapport across the spectrum.
- Excellent people and team management skills.
- Strategic thinking skills and achievement oriented.
- Able to critically analyze 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.
- Executive capability with strategic planning & budget processes such as analytical thinking.
- Strong leadership, coalition-building and communication skills.
- Excellent knowledge of spoken and written English.
- License to practice medicine and board and/ or professional certification is an asset.
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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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