Director, Clinical Operations

Who we are:

MBrace Therapeutics is an oncology company developing first-in-class ADCs directed to novel targets. Its overarching goal is to improve the lives of cancer patients.

Job Description

The Director of Clinical Operations will assist the SVP of Clin Ops in overseeing MBrace’s clinical programs to ensure completion in line with established project team goals and objectives. You will work closely with cross-functional teams to deliver clinical trials that are conducted with operational excellence and in accordance with applicable GCP/ICH guidelines and other regulatory requirements.

Essential Duties and Responsibilities

· Lead one or multiple Programs within MBrace's pipeline, ensuring consistent execution across

compounds and vendors

· Drive cross-functional collaboration with internal departments and external vendors to align

strategies, achieve operational goals, and ensure seamless communication and operational excellence.

· Operate at a strategic level, collaborate with senior management, external partners, and clinical study

teams to influence outcomes and shape the future of clinical operations

· Function as a liaison between departments to optimize workflows

· Compile, assess, and communicate risks and optionality to support informed decision-making for

operational strategy

· Responsible for the daily operations of the clinical trial activities, including those undertaken by CROs,

including budget negotiation, managing change orders, and forecasting

· Identify critical path items and evaluate, propose, and oversee the implementation of proactive

contingency plans/solutions

· Provide a point of escalation for clinical trial execution issues

· Assist with clinical vendor qualification, selection, and ensure Sponsor oversight of study vendors

· Support team and be a champion for maintaining an inspection-readiness philosophy across clinical

programs

Qualifications:

· 10 years of experience working with clinical research organizations to manage global clinical trials

· 8 years' experience managing direct reports and team building

· Comprehensive understanding of ICH and GCP guidelines, as well as applicable regulations and practices

· Excellent organizational skills and attention to detail

· Effective communication (verbal and written) and interpersonal skills (effective conflict

management/resolution)

· Able to work independently while exercising initiative, flexibility, and sound judgment

· Have experience in a fast-paced, entrepreneurial, start-up environment without a built-out infrastructure

in place

· Be a creative, analytical problem solver who acts decisively, yet communicates the risks and benefits

associated with all potential solutions so that informed business decisions can be made

· Science degree in a relevant discipline

Salary Range: $160,000-$240,000