We are representing a cutting-edge, clinical-stage biopharmaceutical company dedicated to revolutionizing the treatment of autoimmune diseases. Using innovative approaches in cell therapy and advanced T cell engineering, we aim to suppress and eliminate the underlying causes of autoimmune and inflammatory diseases. Our focus is on delivering groundbreaking therapies that offer new hope to patients while setting the standard for innovation in synthetic biology, immunology, and cell engineering.
Position Overview:
The Executive Director/VP of Clinical Operations will play a pivotal role in driving the strategic and operational success of clinical programs. Reporting to senior leadership, this individual will lead the clinical operations team, oversee the planning and execution of clinical trials, and manage key external relationships. The ideal candidate will bring extensive experience in clinical research and a passion for innovation in autoimmune disease therapeutics.
Key Responsibilities:
Develop and implement clinical operational strategies to ensure the successful delivery of clinical programs aligned with corporate goals.
Serve as a key member of cross-functional leadership teams, providing strategic input to product development and clinical program planning.
Build, lead, and mentor a high-performing clinical operations team, fostering a culture of collaboration and excellence.
Manage relationships with external stakeholders, including CROs, academic partners, and advocacy groups, to ensure program success.
Oversee clinical trial planning and execution, including enrollment strategies, timelines, and budgets, with a focus on complex autoimmune and rare diseases.
Collaborate with technical operations to ensure accurate demand forecasting for cell therapy manufacturing.
Contribute to protocol development, case report forms, clinical study reports, and regulatory submissions.
Identify, assess, and resolve risks, ensuring compliance with ICH-GCP and other regulatory guidelines.
Lead initiatives to enhance the capabilities and efficiency of the R&D organization in response to evolving business needs.
Act as a role model for collaboration, problem-solving, and innovation within the clinical operations and extended cross-functional team.
Qualifications:
Bachelor's degree in life sciences/healthcare required; advanced degree preferred.
Minimum of 16 years of clinical research operations experience in pharmaceutical, biotech, or CRO settings, with expertise in Phase I-IV studies.
Strong background in complex autoimmune disorders, neurology, rheumatology, rare diseases, or cell therapy preferred.
Proven track record of solving challenges in complex clinical studies and ensuring compliance with GCP/ICH guidelines and other regulatory frameworks.
At least 12 years of line management experience, with a demonstrated ability to build and manage high-performing teams.
Exceptional skills in influencing, negotiation, problem-solving, and project management.
Excellent communication and interpersonal skills, with the ability to establish effective relationships with internal and external stakeholders.