Senior Clinical Trial Manager, Oncology
Eikon Therapeutics is a biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. Our discovery platform is built on groundbreaking innovations from Nobel Prize-winning founders, enabling real-time, molecular-resolution measurements of protein movement in living cells to unlock intractable drug targets.
About the role
As a Senior Clinical Trial Manager, you will lead and oversee global clinical trial operations in a dynamic, collaborative environment. You will provide strategic direction and hands-on management to ensure the successful execution of clinical trials across multiple regions, contributing to the development of groundbreaking therapies. This role requires minimal oversight and close collaboration with cross-functional teams to deliver studies on time, within budget, and with exceptional quality. Onsite presence is required a minimum of 3 days per week (or more as needed) in either our Jersey City, NJ or Millbrae, CA offices to support team growth, collaboration, and operational excellence.
Responsibilities
- Develop and implement strategic plans for clinical trials, overseeing all aspects of trial execution, including planning, monitoring, and closeout.
- Coordinate local processes, clinical and ancillary supplies management, importing/exporting requirements, supplies destruction, local electronic/hard copy filing, archiving, retention requirements, and insurance process management in collaboration with the TMF Operations team.
- Lead and mentor a team of clinical trial associates, coordinators, and specialists, fostering a high-performing and collaborative work environment.
- Ensure strict adherence to relevant regulations, protocols, and standard operating procedures (SOPs), staying abreast of changes in regulatory requirements. Ensure clinical studies comply with approved protocols, ICH-GCP, EMEA, PMDA, and other relevant guidelines.
- Manage and maintain accurate, up-to-date trial documentation to meet regulatory and industry standards.
- Collaborate with recruitment teams to optimize patient recruitment strategies and ensure timely enrollment of eligible participants.
- Oversee data collection, entry, and validation processes to maintain clinical trial data integrity.
- Foster effective communication and collaboration among cross-functional teams, including investigators, study coordinators, vendors, and other stakeholders.
- Implement and oversee quality control processes to maintain the highest standards of data accuracy and trial conduct.
- Manage trial budgets and allocate resources effectively to ensure success within financial constraints.
- Enter and update country information in clinical, regulatory, safety, and finance systems.
- Contribute to or lead initiatives and projects that add value to the enterprise.
Qualifications
- Postgraduate degree with 6+ years of experience or a Bachelor’s degree with 8+ years of experience in a relevant field (e.g., life sciences, healthcare, or related discipline).
- Substantial experience in clinical trial management, including leadership roles.
- Strong organizational skills with meticulous attention to detail.
- Exceptional communication and leadership capabilities.
- Proficiency in Microsoft Office Suite and clinical trial management software.
- Ability to thrive in a fast-paced and evolving work environment.
- In-depth knowledge of clinical trial processes, regulations, and industry best practices.
Benefits
- 401k plan with company matching
- Medical insurance (premiums covered at 95% by Eikon)
- Dental and vision insurance (premiums covered at 100% by Eikon)
- Mental health and wellness benefits
- Weeklong summer and winter holiday shutdowns
- Generous paid time off and holiday policies
- Life/AD&D Insurance (premiums covered at 100% by Eikon) with optional supplemental employee-paid policies
- Enhanced parental leave benefit
- Daily subsidized lunch program when on-site
Pay
The expected salary range for this role is $143,000 to $173,250, depending on skills, competency, and market demand.