Director, Scientific Lead - Specialty/General Medicine

GlaxoSmithKline
United States, Massachusetts, Cambridge
Nov 21, 2024
Site Name: USA - Pennsylvania - Upper Providence, Belgium, Cambridge MA, UK - London - New Oxford Street, USA - District of Columbia - Washington Dc Posted Date: Nov 14 2024 GSK is a global healthcare company committed to improving the quality of human life by enabling people to do more, feel better, and live longer. We discover, develop, and deliver innovative medicines, vaccines, and consumer healthcare products, and we are dedicated to our mission of helping people around the world. At GSK, we are dedicated to creating an inclusive and diverse workplace that reflects the communities we serve. We offer competitive compensation and benefits packages, opportunities for professional development, and a culture that values innovation, collaboration, and integrity. Position Summary: The Director, Scientific Lead, Interventional Studies will lead and oversee the execution of the Specialty/Gen Med 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 Specialty/Gen Med 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. Minimum Qualifications: Advanced degree in a relevant scientific discipline (MD, PhD, PharmD, or equivalent) Minimum of 10 years of experience in clinical research Experience working with regulatory requirements and industry standards for clinical research, including being a medical monitor. 5 or more years in a leadership role overseeing interventional studies Preferred Qualifications: Proven track record of successful leadership and management of large-scale interventional clinical trials. 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. #LI-GSK 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. 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