Director, Trial Master File Operations

Position

As the Director, Trial Master File Operations, you will be responsible for leading the TMF (Trial Master File) operations function for clinical trials across Eikon Therapeutics. This is a senior-level position that requires a strategic thinker with the ability to drive change and improve processes. The successful candidate will be a strong leader with excellent communication and collaboration skills, and experience in managing TMFs for clinical trials. You will be accountable for ensuring the completeness, accuracy, and regulatory compliance of TMFs, and overseeing all TMF-related activities across the clinical trial portfolio.

This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in either of our Jersey City (NJ), New York City (NYC) or Millbrae (CA) 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 strategic and collaborative leader that drives transformative initiatives to create efficient processes that meet rigorous quality standards. You are an effective change manager with the ability to be hands on to achieve organizational objectives in support of the business and TMF needs across the entire Clinical Research & Development organization. You have exceptional proficiency in utilizing data to drive decision-making and performance improvements.

What You'll Do

1. Lead the TMF Operations function to support Clinical Research and Development
2. Manage and oversee the TMF Operations team, including hiring, training, and performance management
3. Manage, provide direction, and maintain strong relationships with TMF third party vendors, including driving resolution of issues and remediation activities
4. Oversee on-site TMF facilities and off-site records storage facilities, including ensuring compliant chain-of-custody procedures
5. Develop and implement TMF processes and procedures, and TMF-related training materials that adhere to regulatory requirements and industry best practices
6. Develop and maintain strong relationships with internal stakeholders, including acting as a subject matter expert for TMF operations and requirements
7. Collaborate with cross-functional teams to ensure TMF completeness and accuracy throughout the trial lifecycle
8. Manage the quality control of TMF documents according to GCP and regulatory requirements from study start-up through inspection readiness and archival
9. Develop and establish TMF Key Performance Indicators (KPIs) globally for internal staff, CRO, and other stakeholders
10. Monitor and report TMF metrics to senior management, identifying areas for process improvement and implementing changes as needed
11. Monitor and report on TMF completeness and readiness to Clinical Trial Teams, including study specific TMF review activities
12. Serve as functional TMF inspection lead for regulatory inspections, providing relevant documents and information as required
13. Identify root cause of performance issues, determine the appropriate remediation, and implement solutions as required
14. Keep informed of regulatory changes and industry best practices related to TMF operations and coordinate with stakeholders to implement continuous operational excellence
15. Serve as eTMF platform business owner, including managing eTMF system configuration changes in accordance with established change control processes and monitoring the impact of configuration changes to optimize performance
16. Serve as sponsor archivist providing oversight of the contents and access to the archive

Qualifications

1. Minimum of 12+ years of experience with a Bachelor's degree, or 10+ years of experience with a post graduate degree
2. Strong understanding of regulatory requirements (e.g., ICH-GCP, FDA, EMA) and industry best practices for TMF operations
3. Experience with electronic Trial Master File systems (e.g., Veeva) and related technology platforms
4. Proficient knowledge of DIA TMF Reference Model
5. Knowledge of clinical trial operations and processes, preferred
6. Demonstrated leadership skills to drive results to achieve optimal outcomes
7. Experience in managing a team and providing leadership to drive performance
8. Excellent communication skills and ability to collaborate with cross-functional teams
9. Ability to manage multiple projects simultaneously and meet tight deadlines
10. Ability to work onsite at least 3 days a week

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

1. 401k plan with company matching
2. Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)
3. Mental health and wellness benefits
4. Weeklong summer and winter holiday shutdowns
5. Generous paid time off and holiday policies
6. Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies
7. Enhanced parental leave benefit
8. Daily subsidized lunch program when on-site

The expected salary range for this role is $200,000 to $218,500 depending on skills, competency, and the market demand for your expertise.