Site Name: USA - Pennsylvania - Upper Providence, UK – London – New Oxford Street
Posted Date: Nov 14 2024
The Director Scientific Lead, Interventional Studies will lead and oversee the execution of the Vaccines/Oncology sponsored clinical trials by the medical affairs organization (non-regulatory label directed programs). This pivotal role requires a leader with deep expertise in industry-sponsored clinical research & global medical affairs, have significant commercial acumen, and cross-functional team management. The lead will ensure that all interventional studies 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.
Key Responsibilities:Strategic Leadership:Implement the strategic vision for Medical Affairs interventional studies aligning with GSK's overarching goals.Lead the design and execution of interventional medical affairs clinical trials from Phase I through Phase IV across Vaccines/Oncology.Ensure alignment of interventional study strategies with regulatory requirements and industry best practices.Operational Management:Oversee the operational aspects of interventional studies, including planning, budgeting, resource allocation, and timeline management.Collaborate with cross-functional teams to ensure seamless execution and delivery of clinical programs, in particular the clinical development operations and biostatistics teams, as well as third-party vendors.Monitor and manage study progress, ensuring compliance with protocols, regulatory requirements, and GSK standards.Team Leadership:Build, mentor, and lead a high-performing team of clinical research professionals.Foster a collaborative and innovative culture within the interventional studies team.Provide guidance and support for professional development and career growth of team members.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, with at least 5+ years in a leadership role overseeing interventional studies.Experience leading and managing large-scale interventional clinical trials.Experience with regulatory requirements and industry standards for clinical research.Experience being a medical monitor.Preferred Qualifications:Exceptional leadership, communication, and interpersonal skills.Strong strategic thinking and problem-solving abilities.Ability to thrive in a fast-paced, dynamic environment and manage multiple priorities.
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