Eikon Therapeutics · 4 months ago
Associate Director, Clinical Study Management
Millbrae, CA
Full-time
Onsite
Senior Level, Lead/Staff
$183K/yr - $200K/yr
10+ years expEikon Therapeutics is a new biopharmaceutical company employing revolutionary technology to discover novel treatments for life-threatening diseases. The Associate Director, Clinical Study Management, will oversee the execution of clinical trials in oncology and other therapeutic areas, ensuring successful completion within timelines and budgets while maintaining high-quality standards.
BiotechnologyHealth CareLife ScienceMedical
Responsibilities
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
Qualification
Required
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
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
Company
Eikon Therapeutics
Eikon Therapeutics is a biopharmaceutical company that develops live-cell resolution microscopy and engineering for drug discovery.
201-500 employees
H1B Sponsorship
Eikon Therapeutics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (12)
2024 (17)
2023 (7)
2022 (3)
2021 (1)
Funding
Current Stage
Late StageTotal Funding
$1.12BKey Investors
The Column Group
2025-02-26Series D· $350.7M
2023-06-01Series C· $106M
2022-01-06Series B· $518M
Leadership Team
Roger Perlmutter
Chairman, President, and CEO
Michael Klobuchar
Chief Operating Officer
Recent News
General Catalyst
2025-12-26
2025-12-02
Company data provided by crunchbase