Associate Director, Clinical Study Manager

Job Description

The Associate Director, Clinical Study Management, will be responsible for overseeing the execution of clinical trials in oncology and other therapeutic areas, as required. This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in our California office to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration. 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 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 collaborative, solutions oriented, flexible and have global clinical operational experience, with a passion for excellence in advancing patient care in oncology.

What You’ll Do

• Team leader and builder, who manages clinical trial deliverables, timelines, and budgets per the Clinical Development and Operational Plans
• Works with minimal oversight from the Clinical Operations Senior Director or Director, in collaboration with Clinical Study Management teams and Clinical Research and Development functional teams
• Demonstrate broad understanding of therapeutic and clinical drug development expertise to influence study design and program-level decisions
• Provide direction to cross-functional study teams to ensure successful study execution Ensure that clinical studies are conducted following approved protocols, FDA Regulations, ICH-GCP, EMA, PMDA, other relevant regulations, directives, and guidelines, and company procedures and quality documents
• Oversee risk identification, assessment, and mitigation strategies to ensure patient safety and data integrity
• Responsible for the implementation of processes and systems that will facilitate inspection readiness throughout the lifecycle of the trial.
• Oversee the preparation and maintenance of detailed clinical trial project timelines
• Manage ancillary (non CRO) vendor relationships and performance to ensure that clinical studies are completed following contract specifications of time, cost and quality.
• Work with finance, legal, and external vendors to ensure the assigned studies are meeting the target milestones
• Provide regular updates on study progress to stakeholders (e.g., Clinical Operations, Project & Portfolio Management, Clinical Research)
• Ensure that all study-related documents are accurate, complete, timely and filed appropriately in all clinical (Veeva TMF), regulatory, safety and finance systems.
• Responsible for hiring, performance management, career development, and providing mentorship to Clinical Study Management personnel.
• Contribute to initiatives and projects adding value to Eikon Therapeutics

Qualifications

• Minimum of 10 years of related experience with a Bachelor’s degree or 8 years and a post-graduate degree.
• Experience leading large, global clinical trials, preferably in oncology
• In-depth knowledge of ICH-GCP, EMA guidelines and other relevant regulations and guidelines.
• Proven ability to manage clinical studies within timelines and budgets while maintaining high quality standards and patient safety.
• Strong leadership and communication skills, with a demonstrated ability to work collaboratively with cross-functional teams.
• Experience with management of the budget, resources, headcount, processes and controls, productivity, quality and project delivery.
• High sense of accountability and urgency to prioritize deliverables.
• Growth mindset and capable of working independently.