Clinical Trials Program Manager
2 days ago
About the Role
GSK is seeking a highly experienced Executive Director Clinical Research to lead our clinical development programs within the hepatology therapeutic area. This role will involve strategic oversight, leadership, and management of clinical trials, ensuring scientific integrity and adherence to regulatory requirements.
This position reports to the VP Clinical Research Head, Hepatology- Clinical Research and Early Programs in the Respiratory and Immunology Research Unit (RIRU). The successful candidate will be responsible for providing strategic leadership and direction for the design, execution, and management of clinical trials in hepatology.
The ideal candidate will have a strong background in hepatology research, clinical trial methodologies, and regulatory changes. They will also have experience successfully leading and managing clinical trials, as well as regulatory requirements, Good Clinical Practice (GCP), and ethical guidelines for clinical research.
We are looking for a dynamic and experienced professional who can stay abreast of advancements in hepatology research, clinical trial methodologies, and regulatory changes to maintain GSK's competitive edge.
Key Responsibilities:
- Provide strategic leadership and direction for the design, execution, and management of clinical trials in hepatology.
- Oversee the development and implementation of clinical trial protocols, ensuring alignment with regulatory requirements and GSK's scientific standards.
- Collaborate with cross-functional teams, including research, regulatory affairs, medical affairs, and commercial teams, to ensure cohesive and comprehensive clinical development plans.
- Serve as the primary point of contact for internal and external stakeholders, including regulatory agencies, key opinion leaders, and clinical investigators.
- Ensure the integrity, safety, and efficacy of clinical trials through rigorous monitoring, data analysis, and risk management.
- Manage senior clinical scientists and physician scientists (direct reports) working on hepatology assets.
- Stay abreast of advancements in hepatology research, clinical trial methodologies, and regulatory changes to maintain GSK's competitive edge.
- Contribute to above asset hepatology strategy.
- Assist in clinical evaluation of business development opportunities.
- Represent GSK in scientific meetings, conferences, and industry forums to advance our hepatology clinical research initiatives.
Basic Qualifications:
- Medical degree with board certification/eligibility or registration qualifications in gastroenterology/hepatology.
- Minimum of 10 years of experience in clinical research and development, with a focus on hepatology or related therapeutic areas.
- Regulatory experience to support product registration and GCP principles.
- Experience successfully leading and managing clinical trials.
- Experience with regulatory requirements, Good Clinical Practice (GCP), and ethical guidelines for clinical research.
Estimated Salary Range:$180,000 - $250,000 per annum, depending on location and experience.
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