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Director, Process Management - Clinical R&D

10-12 years
$208,000 – $227,050
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, Process Management – Clinical R&D

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


Job Type: Full-time

Salary Range: $208,000 – $227,050 (plus bonus & equity)


About the Company

Eikon Therapeutics is a cutting-edge biotech company leveraging real-time, molecular-resolution imaging developed by its Nobel Prize-winning founders to unlock new drug targets and discover treatments for life-threatening diseases.


Role Summary

The Director, Process Management – Clinical R&D will lead business process design, optimization, and continuous improvement efforts to ensure efficiency, compliance, and scalability of Clinical Research & Development operations. This is a strategic leadership role aimed at strengthening Eikon’s operational readiness as it scales its portfolio and team.


Key Responsibilities

  • Provide strategic direction for designing and scaling business processes within Clinical R&D

  • Lead development and maintenance of SOPs, policies, job aids, and process maps

  • Collaborate with process and IT system owners to align operational processes with clinical development goals

  • Identify process gaps and implement improvements using data-driven analysis and KPIs

  • Oversee implementation of clinical systems (e.g., CTMS, eTMF) and ensure regulatory compliance

  • Support GCP audit readiness and inspection response efforts

  • Develop training programs for new and updated procedures and systems

  • Monitor industry trends and regulatory updates to inform internal process improvements


Qualifications

  • 12+ years of clinical drug development experience (10+ with post-grad degree)

  • Proven background in biotech/pharma with strong process development and system implementation expertise

  • Deep knowledge of ICH-GCP, FDA, EMEA, and other global clinical regulations

  • Experience with Veeva Quality Vault and Veeva Clinical Platform preferred

  • Strong leadership, collaboration, and change management skills

  • Excellent analytical, written, and verbal communication skills


Compensation & Benefits

  • Competitive base salary, performance bonus, and equity

  • 401(k) plan with company match

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

  • Generous paid time off, plus summer and winter shutdowns

  • Life and AD&D insurance fully covered by Eikon

  • Enhanced parental leave

  • Mental health & wellness benefits

  • Daily subsidized lunch for on-site employees


Diversity & Inclusion

Eikon is an equal opportunity employer committed to building a diverse and inclusive workplace.