Director, Clinical Operations

Myrixc Bio is a UK biotech Company focused on the discovery and development of a completely novel class of selective cytotoxic payloads for antibody drug conjugates (ADCs), based on inhibitors of N-myristoyltransferases (NMT) for the treatment of cancer. Myricx Bio recently announced the closing of its series A financing raising £90m ($114m), the largest of a university spin-out in Europe in 2024.

We are now looking to progress our first asset into clinic and are looking to recruit a Director of Clinical Operations. In this key leadership role, the successful candidate will be responsible for the strategic planning, execution, and oversight of clinical trials, with a primary focus on oncology development programs.

Role Overview;

This individual will work in cross-functional study teams and oversee the selection and management of Contract Research Organisations (CROs). A successful candidate will possess significant experience managing international clinical trials and will demonstrate expertise in all aspects of clinical operations, from study start-up to close-out. This role requires a highly organised, results-oriented individual with a strong ability to drive projects forward in a fast-paced environment.

Key Responsibilities:

Clinical Trial Management:

• Manage clinical studies ensuring adherence to GCP, SOPs, and regulatory requirements.
• Oversee study timelines, budgets, and resource allocation.
• Drive study progress by proactively identifying issues and implementing corrective actions.
• Actively participate in study team meetings and communicate progress updates effectively.

CRO Management:

• Lead the CRO selection process, including RFP development, vendor evaluations, and contract negotiations.
• Establish and maintain effective working relationships with CRO partners.
• Oversee CRO performance, ensuring adherence to quality standards, timelines, and budgets.
• Conduct regular CRO oversight meetings and address any performance issues promptly.

Strategic Leadership:

• Develop and implement strategic operational plans for oncology clinical programs aligned with corporate goals and timelines.
• Contribute to the development of clinical protocols, case report forms (CRFs), and other essential study documents.
• Provide input on clinical development plans and contribute to the overall clinical strategy.
• Identify and mitigate potential operational risks and challenges.

Leading International Trials

• Directly manage or oversee the conduct of international clinical trials predominantly across the US,
• Possess a strong understanding of international regulatory requirements and cultural nuances related to clinical trials.
• Experience working with local investigators and regulatory authorities in different countries.

Budget Management:

• Develop and manage clinical trial budgets, ensuring cost-effective resource utilization.
• Track expenditures and manage project financials closely.

Regulatory Compliance:

• Ensure that all clinical activities are conducted in compliance with GCP, ICH guidelines, and relevant regulations.
• Prepare for and participate in regulatory audits.

Process Improvement:

• Identify opportunities to improve operational processes and implement best practices.
• Contribute to the development and maintenance of SOPs.

Requirements:

• Bachelor\’s degree in a scientific discipline (e.g., biology, chemistry, life sciences).
• Extensive experience in clinical operations within the pharmaceutical or biotechnology industry, with a strong focus on oncology development.
• Experience with early-phase Oncology clinical trials (Phase I/II).
• Experience with regulatory submissions (IND/NDA)
• Extensive hands-on experience in managing all aspects of clinical trials, including study start-up, conduct, and close-out.
• Proven track record of successfully managing and overseeing CROs, including selection, negotiation, and ongoing management.
• Demonstrated experience managing international clinical trials across North America
• Strong understanding of GCP, ICH guidelines, and relevant regulatory requirements.
• Excellent leadership, communication, and interpersonal skills.
• Ability to work effectively in a fast-paced, dynamic, and team-oriented environment.
• Strong problem-solving and decision-making skills.
• Excellent project management and organisational skills.
• Experience with electronic data capture (EDC) systems and other clinical trial technologies.

Desirable skills:

• Experience with various oncology treatment modalities (e.g., Antibody Drug Conjugates, immunotherapy, targeted therapies, cell therapies. chemotherapy).
• Experience with data management and biostatistics

What’s in it for you? Why work at Myricx

We are a small but rapidly growing team, with a vision to advance a pipeline of ADCs based on our novel NMT inhibitor (NMTi) payload chemistry platform to address serious unmet needs in oncology. As an early joiner, you will have a unique opportunity to help shape our trajectory and make real impact from day one.

Myricx Bio s an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.