Search for Director of Trial Master File Operations roles in Millbrae, CA, with a focus on biopharmaceuticals, requiring at least 12 years of experience, and managing a team, specifically with knowledge of electronic TMF systems.

Okay, I've searched for Director of Trial Master File Operations roles in Millbrae, CA, focusing on the biopharmaceutical industry. The positions require at least 12 years of experience and experience in team management, particularly with electronic Trial Master File systems. I found 23 positions that fit your criteria.

Director, Trial Master File Operations

Millbrae, CA

Biopharmaceuticals

12 years + Experience

electronic TMF systems

Can you help me to analyze the job description and company culture?

Sure. Here's the analysis:

Job Analysis:

The role of Director, Trial Master File Operations at Eikon Therapeutics is crucial for ensuring that clinical trials are managed with rigor and compliance. The successful candidate will be fundamentally tasked with leading the Trial Master File (TMF) operations, which support all critical functions of clinical research and development. This includes overseeing the completeness and regulatory compliance of TMFs, enhancing operational processes, and managing a team of professionals — all within a rapidly growing biopharmaceutical setting that is driven by innovation. Key responsibilities involve developing TMF processes, collaborating with cross-functional teams, and acting as the point of contact for TMF requirements. The expectation is not only to manage existing workflows but to drive transformative initiatives for improved efficiency. Candidates will need to navigate complex scenarios, such as addressing regulatory inspections and maintaining strong vendor relationships, while simultaneously fostering an organizational culture oriented towards quality and data-driven decision-making. Success in this role would look like the seamless execution of trial processes, high-quality TMF documentation, and demonstrating a proactive approach in identifying and implementing improvements to existing systems, thus enhancing overall clinical trial performance.

Company Analysis:

Eikon Therapeutics operates at the cutting edge of biopharmaceutical innovation, leveraging revolutionary technologies to unlock novel treatments for life-threatening diseases. With its strong academic foundation stemming from Nobel Prize-winning research, the company is positioned as a disruptor in the industry—an innovative force that combines biology, chemistry, and engineering to redefine drug discovery. This forward-thinking context signifies a fast-paced environment where the Director of TMF Operations must not only adapt but also lead in developing efficient processes that align with Eikon's mission. The culture at Eikon appears to value collaboration, creativity, and excellence in quality, indicating that the successful candidate will need to thrive in a dynamic team-oriented environment. Given that this role is senior-level and directly affects clinical trial oversight, the person will likely enjoy high visibility, working close to executive leadership and influencing company-wide initiatives. The organization is engaged in continuous growth, and this position is strategic not only for managing TMFs but also for leading compliance and operational excellence — making it integral to Eikon’s overarching goals of improving patient outcomes through innovative therapies.

Mock up some interview questions based on the job description.

Absolutely. Here are some mock interview questions that could come up:

Can you describe a time when you successfully improved a process related to TMF operations? What was the impact?
Tell me about a challenge you faced when managing TMF compliance during a clinical trial and how you resolved it.
How do you prioritize and manage multiple TMF-related projects to meet tight deadlines?
What strategies do you employ to foster collaboration among cross-functional teams, especially when it comes to TMF accuracy?
What experience do you have with electronic TMF systems, and how have you utilized data to drive performance improvements?
How would you approach establishing Key Performance Indicators (KPIs) for TMF operations?
Imagine you discover a significant discrepancy in TMF documentation during a regulatory inspection prep. What steps would you take?
If a vendor was not following the agreed chain-of-custody procedures for TMF documentation, how would you address the situation?
What methods do you use to stay informed about regulatory changes impacting TMF operations?
Why are you interested in the Director, TMF Operations position at Eikon Therapeutics specifically?
How do your personal values as a leader align with Eikon's mission to discover novel treatments for life-threatening diseases?
What excites you about the prospect of leading TMF operations in a company known for its groundbreaking technology?
What questions do you have about Eikon's approach to innovation in drug discovery and how this role contributes to that vision?
Can you elaborate on your experience with compliance frameworks, particularly in relation to ICH-GCP and FDA regulations?

Job Details

Overview Company

Director, Trial Master File Operations

$200k/y-$218.5k/y

Eikon Therapeutics

a day ago

Highlight

HybridFull-time12+ yearsDirector

Summary

Eikon Therapeutics is seeking a Director, Trial Master File Operations to join their team in Millbrae, CA. The role involves leading TMF operations for clinical trials, ensuring regulatory compliance, and driving process improvements.

About the Role

As the Director, Trial Master File Operations, you will lead the TMF Operations function to support Clinical Research and Development. Responsibilities include managing the TMF Operations team, overseeing third-party vendors, developing TMF processes, and ensuring compliance with regulatory requirements. You will also serve as the eTMF platform business owner and sponsor archivist, and act as the functional TMF inspection lead for regulatory inspections.

About You

Required:

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.
Demonstrated leadership skills to drive results and achieve optimal outcomes.
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.

Preferred:

Knowledge of clinical trial operations and processes.

Benefits

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.

Eikon Therapeutics

Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the interface of biology, engineering and chemistry 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.

By directly measuring the effects of chemical compounds on the behavior of protein molecules in a live cellular environment, Eikon’s landmark assays facilitate the highly sensitive identification of compound-protein interactions that could not be identified through traditional assays, thereby unlocking otherwise intractable classes of proteins as drug targets. Furthermore, the ability to directly visualize protein mechanisms in disease coupled with the extraordinarily high-powered high-content data sets generated by Eikon’s drug-screening technology enable an unprecedented opportunity to quantitatively explore novel biology in the living cell. These insights facilitate creation and application of data-driven hypotheses to the discovery of life-saving therapies.

Eikon is seeking adventurous, passionate and creative team members eager to apply their talents to empower interdisciplinary scientific exploration, inaugurate a radical drug-discovery paradigm, and ultimately create novel medicines. To learn more about open positions, please visit: https://www.eikontx.com/join-us/#open-positions

Millbrae, CA