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The Scientist - Medical Affairs Interventional Studies, Specialty & General Medicine will oversee the execution of a program of sponsored clinical trials by the medical affairs organization (non-regulatory label directed programs). This role requires a manager with expertise in industry sponsored clinical research & global medical affairs,and have good cross-functional team management. The scientist will ensure that all interventional studies under their scope are conducted to the highest standards of quality, ethics, and efficiency, utilizing the latest clinical trial innovations including digital health, driving forward GSK’s pipeline of innovative therapeutics. They will work in a matrix manner with the Global Medical Affairs therapy area teams, and the clinical operation & Biostatistics organization to execute the program of work.
Key Responsibilities:
Operational Management:
Oversee the operational aspects (delivered by clinical operations & Biostatistics) of medical affairs interventional studies, including planning, budgeting, resource allocation, and timeline management.
Collaborate with cross-functional R&D teams to ensure seamless execution and delivery of clinical programs, as well as third party vendors.
Monitor and manage study progress, ensuring compliance with protocols, regulatory requirements, and GSK standards.
Regulatory and Compliance:
Ensure that all interventional studies are conducted in accordance with GCP, and other relevant regulatory guidelines.
Maintain oversight of all regulatory submissions and interactions related to interventional studies.
Ensure robust quality control and assurance processes are in place for all clinical trials.
Stakeholder Engagement:
Serve as the primary point of contact for internal and external stakeholders regarding interventional studies.
Collaborate with key opinion leaders, investigators, and external partners to enhance study design and execution.
Communicate study progress, challenges, and outcomes to senior leadership and other relevant stakeholders.
Innovation and Continuous Improvement:
Identify and implement innovative approaches to improve the efficiency and effectiveness of interventional studies.
Stay abreast of industry trends, emerging technologies, and new methodologies in clinical research.
Promote a culture of continuous improvement within the interventional studies team.
Basic Qualifications:
Advanced degree in a relevant scientific discipline (MD, PhD, PharmD, or equivalent).
10 or more years of experience in clinical research
Experience managing large-scale interventional clinical trials.
Experience with regulatory requirements and industry standards for clinical research, including being a
Experience as a medical monitor.
Preferred Qualifications:
Good leadership, communication, and interpersonal skills.
Strong problem-solving abilities.
Ability to thrive in a fast-paced, dynamic environment and manage multiple priorities.
Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
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