Director of Clinical Operations
Director of Clinical Operations
Location: Flexible (U.S. or Europe-based biotech hub preferred)
A stealth-mode biotechnology company is pioneering a new class of immune medicines by decoding and directing the human immune system to combat cancer and autoimmune diseases. Built on a proprietary platform that enables deep profiling of T cell receptor (TCR) and antigen interactions, the company is advancing a pipeline of precision immunotherapies designed to either activate immune responses against tumors or restore immune tolerance in autoimmune conditions.
The organization operates from dual research hubs in North America and Europe and is backed by a leading life sciences venture firm. It has also entered into a strategic collaboration with a major pharmaceutical partner to co-develop next-generation tolerizing vaccines.
Pipeline Overview
The company's pipeline includes:
TCR Bispecific Molecules: Targeting a range of solid tumors and hematologic malignancies.
mRNA Tolerizing Vaccines: Designed to reprogram immune responses in autoimmune diseases such as multiple sclerosis and type 1 diabetes.
Preclinical Programs: Focused on expanding the therapeutic reach of its immune decoding platform into additional oncology and autoimmune indications.
Role Summary
Reporting directly to the Chief Medical Officer, the Director of Clinical Operations will lead the execution and oversight of early-phase oncology clinical trials. This individual will be instrumental in shaping clinical strategy, ensuring operational excellence, and maintaining compliance with regulatory and ethical standards.
Key Responsibilities
- Lead day-to-day operations of clinical trials, from protocol development to study close-out.
- Collaborate with cross-functional teams to design and implement clinical development strategies.
- Manage timelines, budgets, and resource planning for clinical programs.
- Oversee preparation and submission of regulatory documents.
- Drive vendor and site selection, contracting, and performance management.
- Ensure data integrity, safety monitoring, and adherence to GCP and ICH guidelines.
- Build and maintain strong relationships with CROs, investigators, and internal stakeholders.
- Support the development of SOPs and infrastructure to ensure inspection readiness.
Qualifications
- Bachelor's or Master's degree in a life sciences field; advanced degree preferred.
- 10+ years of experience in clinical operations, with at least 5 years in early-phase oncology trials.
- Proven track record in IND submissions and early clinical development.
- Experience with biologics or protein therapeutics is highly desirable.
- Strong leadership and project management skills across complex, cross-functional programs.
- Deep understanding of clinical trial endpoints, regulatory requirements, and operational best practices.
- Excellent communication, organizational, and problem-solving abilities.
Culture & Commitment
This company values diversity, equity, and inclusion as essential to scientific innovation. It is committed to fostering a collaborative and inclusive environment where all team members can thrive and contribute to transformative science.
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