Director, Clinical Operations Study Management

Position

The Director of Clinical Operations Study Management will be responsible for overseeing the execution of multiple global clinical trials in oncology and other therapeutic areas, as required. You will lead a diverse team, ensuring the successful planning, coordination, and management of clinical trials in compliance with regulatory standards and company objectives. The successful candidate will work closely with cross-functional Clinical Research & Development teams to ensure successful completion of studies within timelines and budget, with a focus on exquisite quality to support operational excellence and world class inhouse clinical study management.

This role will require a minimum of 3 days a week of onsite presence (or more as business needs require), in either of our California, New York or New Jersey offices to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration.

About You

You are a collaborative, agile leader with significant oncology global clinical development experience, and have a passion for operational excellence, building and leading inhouse clinical operations and FSP study management teams. You possess a deep understanding of clinical trial regulations, guidelines, and the principles of Good Clinical Practice (GCP), ensuring strict compliance throughout the clinical trial process.

What You’ll Do

• In collaboration with senior clinical operations management, build and lead inhouse clinical operations study management teams responsible for operational delivery of protocols.
• Oversee clinical study planning, execution, and closeout activities, ensuring compliance with all applicable regulations, guidelines, and company policies.
• Provide strategic guidance and direction to cross-functional study teams to ensure successful study execution.
• Ensure that clinical studies are conducted in accordance with approved protocols, ICH-GCP, EMEA, PMDA and other relevant regulations and guidelines.
• Manage study budgets, timelines, and resource allocation to ensure successful completion of studies.
• Develop and maintain strong relationships with study investigators, clinical vendors and other external partners.
• Provide regular updates on study progress to senior leadership and other stakeholders.
• Ensure that all study-related documents are accurate, complete, and filed appropriately.
• Serve as a talent magnet, to manage, develop, coach and retain top Clinical Operations talent in the study teams. Set clear performance standards and hold self and organization accountable for achieving high quality, high impact results.  Embrace metrics and high-performance standards.

Qualifications

• Typically requires a minimum of 12 years of experience with a Bachelor's degree, or 10 years of experience with a post graduate degree
• Experience in clinical study management within the biotechnology, pharmaceutical, or healthcare industry highly preferred. 
• Significant experience managing international clinical studies in oncology, and directly managing global Clinical Operations personnel.
• Demonstrated independence, problem-solving abilities, self-motivation, resourcefulness and ability to work in a fast-paced team environment. High emotional intelligence.
• Exceptional communication skills with an ability to efficiently and productively communicate both orally and in writing. Experience presenting to senior leadership is required.
• In-depth knowledge of ICH-GCP, EMEA, PMDA guidelines and other relevant regulations and guidelines.
• Proven ability to manage international clinical studies within timelines and budget while maintaining high quality standards and patient safety.
• Strong leadership, with a demonstrated ability to work collaboratively with cross-functional teams across diverse cultures and global regions.
• Management expertise should cover management of the budget, resources, headcount, processes and controls, productivity, quality and project delivery.
• Veeva clinical systems experience preferred.
• MS Project experience preferred.

At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:​

• 401k plan with company matching​
• Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)​
• Mental health and wellness benefits​
• Weeklong summer and winter holiday shutdowns​
• Generous paid time off and holiday policies​
• Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies ​
• Enhanced parental leave benefit​
• Daily subsidized lunch program when on-site​

The expected salary range for this role is $226,000 to $247,000 depending on skills, competency, and the market demand for your expertise.

Salary : $226,000 - $247,000