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Director, Clinical Operations Study Management

10-12 years
$226,000 – $247,000
10 May 5, 2025
Job Description
Job Type: Hybrid Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

Job Title: Director, Clinical Operations Study Management

Company: Eikon Therapeutics
Location: Millbrae, CA; New York, NY; Jersey City, NJ (Hybrid – minimum 3 days onsite/week)


Job Type: Full-time

Salary Range: $226,000 – $247,000 (plus bonus & equity)


About the Company

Eikon Therapeutics is a pioneering biotech company advancing a revolutionary live-cell imaging technology platform developed by its Nobel Prize-winning founders. Their mission is to develop life-saving therapeutics by unlocking challenging drug targets through real-time molecular imaging.


Role Summary

The Director of Clinical Operations Study Management will be responsible for leading the operational strategy and execution of global clinical trials, primarily in oncology. This leadership position involves managing cross-functional teams, ensuring regulatory compliance, and delivering trials on time, on budget, and with high quality to support the success of Eikon’s expanding clinical portfolio.


Key Responsibilities

  • Build and manage in-house clinical operations study teams

  • Lead global clinical trials from planning through closeout in compliance with ICH-GCP and global regulations

  • Provide strategic direction to cross-functional study teams

  • Manage clinical study budgets, resources, timelines, and vendor relationships

  • Monitor study progress, quality, and risk mitigation, reporting to senior leadership

  • Develop and implement operational best practices and performance metrics

  • Mentor, develop, and retain high-performing talent within Clinical Operations

  • Ensure complete and accurate clinical documentation and trial master file compliance


Qualifications

  • 12+ years of clinical operations experience (10+ with post-grad degree), preferably in oncology

  • Proven track record of managing global clinical trials and operational teams

  • Strong knowledge of ICH-GCP, FDA, EMEA, and PMDA regulations

  • Excellent leadership, communication, and interpersonal skills

  • Experience with Veeva systems and MS Project preferred

  • Ability to lead in a fast-paced, matrixed environment

  • Experience managing study budgets, headcount, and performance metrics

  • Demonstrated success in stakeholder communication and cross-functional collaboration


Compensation & Benefits

  • Competitive base salary, bonus, and equity

  • 401(k) with company matching

  • 95%+ employer-paid medical, dental, and 100% vision coverage

  • Mental health & wellness benefits

  • Paid parental leave

  • Company-paid life and AD&D insurance

  • Weeklong shutdowns in summer and winter

  • Daily subsidized on-site lunch

  • Generous PTO and holiday policy


Diversity & Inclusion

Eikon Therapeutics is proud to be an equal opportunity employer and values diversity across all teams and roles.