Director, Scientific Lead Interventional Studies, Vaccines/ Oncology

GlaxoSmithKline - Collegeville, PA

Full-time - Senior

Collegeville, PA

Chemical Manufacturing

About the position

The Director Scientific Lead, Interventional Studies will oversee the execution of clinical trials in the Vaccines/Oncology area, ensuring high standards of quality, ethics, and efficiency. This role requires a leader with extensive experience in clinical research and global medical affairs, who can drive innovative approaches and manage cross-functional teams effectively.

Responsibilities

• 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.
• 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.
• Monitor and manage study progress, ensuring compliance with protocols, regulatory requirements, and GSK standards.
• 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.
• 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.
• 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.
• 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.

Requirements

• 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.

Nice-to-haves

• 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.

Benefits

• Comprehensive benefits program including health insurance, retirement plans, and professional development opportunities.