Job Title : Executive Director, Clinical Operations
Location : Boston, MA (Hybrid)
Employment type : Full-time
About the Company :
Our client is a cutting-edge biotechnology company dedicated to transforming the treatment landscape for patients with hematologic malignancies. By combining deep expertise in oncology, immunology, and cell therapy, the company is advancing a pipeline of novel therapies designed to overcome the limitations of current CAR-T and targeted treatment modalities.
Position Overview :
The Executive Director of Clinical Operations will serve as a key member of the clinical leadership team, providing strategic direction and operational oversight for the company’s clinical programs from early development through pivotal studies. This leader will drive clinical execution excellence, build and manage high-performing teams, and ensure programs are delivered with scientific rigor, operational precision, and a sense of urgency to bring transformative therapies to patients in need.
Key Responsibilities :
- Lead the global clinical operations function, overseeing all operational aspects of clinical studies, including planning, execution, vendor oversight, and study delivery.
- Partner closely with Clinical Development, Regulatory, CMC, and Program Management to ensure alignment of clinical strategy and execution across programs.
- Develop and implement robust operational strategies that support efficient and compliant study conduct in cell and gene therapy.
- Drive selection, negotiation, and management of CROs, vendors, and key external partners.
- Oversee clinical trial budgets, timelines, and resources, ensuring programs are delivered within scope and aligned with corporate objectives.
- Provide mentorship and leadership to a growing clinical operations team, fostering a collaborative and accountable culture.
- Contribute to regulatory submissions (IND, CTA, BLA) and inspection readiness activities.
- Represent clinical operations in cross-functional governance and portfolio decision-making forums.
Qualifications :
Advanced degree (MS, PharmD, PhD, or equivalent) in life sciences or related field preferred.15+ years of experience in clinical operations within the biotech or pharmaceutical industry, including 8+ years in oncology.Proven success leading complex global clinical programs, ideally within cell therapy, immuno-oncology, or hematologic malignancies.Demonstrated experience managing CROs and building high-performing teams in a fast-paced, evolving environment.Deep understanding of GCP, global regulatory requirements, and clinical trial operational best practices.Excellent communication, leadership, and strategic planning skills.Why Join :
This is an opportunity to join a mission-driven organization that is redefining the boundaries of cancer treatment. You’ll be part of a passionate, science-first team that values innovation, integrity, and the shared goal of improving outcomes for patients with devastating diseases.
Please apply directly here or feel free to contact me on the below details if you have any more questions :
joel.isaac@vividresourcing.com
1 (980) 222 2267