Director, Trial Master File Operations

Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. Eikon's discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets.

Position

As the Director of 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.

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

• Lead the TMF Operations function to support Clinical Research and Development

• Manage and oversee the TMF Operations team, including hiring, training, and performance management

• Manage, provide direction, and maintain strong relationships with TMF third party vendors, including driving resolution of issues and remediation activities

• Oversee on-site TMF facilities and off-site records storage facilities, including ensuring compliant chain-of-custody procedures

• Develop and implement TMF processes and procedures, and TMF-related training materials that adhere to regulatory requirements and industry best practices

• Develop and maintain strong relationships with internal stakeholders, including acting as a subject matter expert for TMF operations and requirements

• Collaborate with cross-functional teams to ensure TMF completeness and accuracy throughout the trial lifecycle

• Manage the quality control of TMF documents according to GCP and regulatory requirements from study start-up through inspection readiness and archival

• Develop and establish TMF Key Performance Indicators (KPIs) globally for internal staff, CRO, and other stakeholders

• Monitor and report TMF metrics to senior management, identifying areas for process improvement and implementing changes as needed

• Monitor and report on TMF completeness and readiness to Clinical Trial Teams, including study specific TMF review activities

• Serve as functional TMF inspection lead for regulatory inspections, providing relevant documents and information as required

• Identify root cause of performance issues, determine the appropriate remediation, and implement solutions as required

• Keep informed of regulatory changes and industry best practices related to TMF operations and coordinate with stakeholders to implement continuous operational excellence

• 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

• Serve as sponsor archivist providing oversight of the contents and access to the archive

Qualifications

• Minimum of 12+ years of experience with a Bachelor's degree, or 10+ years of experience with a post graduate degree

• Strong understanding of regulatory requirements (e.g., ICH-GCP, FDA, EMA) and industry best practices for TMF operations

• Experience with electronic Trial Master File systems (e.g., Veeva) and related technology platforms

• Proficient knowledge of DIA TMF Reference Model

• Knowledge of clinical trial operations and processes, preferred

• Demonstrated leadership skills to drive results to achieve optimal outcomes

• Experience in managing a team and providing leadership to drive performance

• Excellent communication skills and ability to collaborate with cross-functional teams

• Ability to manage multiple projects simultaneously and meet tight deadlines

• 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:

• 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 $200,000 to $218,500 depending on skills, competency, and the market demand for your expertise.

Eikon is proud to be an equal opportunity employer and will consider all qualified applicants for employment.

In accordance with the Company's duty to provide and maintain a safe workplace, the Company requires all employees to be Fully Vaccinated with one of the FDA approved COVID-19 vaccines, which includes those vaccines that have received the FDA's emergency use authorization. You will be expected to be Fully Vaccinated as of your Start Date. If you believe that you are exempt from this requirement under an applicable law or regulations, including Americans with Disabilities Act and California's Fair Employment and Housing Act, you will need to contact the Company's Human Resources group. For purposes of this section, Fully Vaccinated means (i) the completion of the vaccination regimen as approved by the FDA (by way of example, 2 doses of the Pfizer or Moderna vaccine and 1 dose of the Johnson and Johnson vaccine), and (ii) timely receiving booster vaccination, as recommended by the Centers for Disease Control and Prevention.

We are currently not accepting any new third-party agencies or firms at this time. Please do not forward unsolicited agency resumes to our website, employees or Human Resources. Eikon Therapeutics will not pay fees to any third-party agency or firm associated with unsolicited resumes.