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Executive Director, Global Clinical Operations

1 hour, 44 minutes ago
United States
Full-time
Lead
Program Manager
Project and Program Management
Apply Now
Apogee Therapeutics

Apogee Therapeutics

Apogee Therapeutics, Inc. is a biotechnology company dedicated to developing innovative biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease, and other inflammatory and immune diseases with high unmet needs. Their goa...

Biotechnology
1-10
Founded 2022
$169M raised
View All Jobs 14

Description

  • Lead the strategic operational management, tactical planning, and execution of global Phase II-III clinical trial programs.
  • Manage, plan, and mentor Clinical Trial Operations resources and teams supporting assigned programs.
  • Represent Clinical Operations on global development teams and program teams, providing operational input and oversight.
  • Identify risks, critical path items, and variances, and implement contingency plans and issue-resolution strategies.
  • Partner cross-functionally with internal stakeholders and external vendors to deliver programs on time, on budget, and in compliance.
  • Monitor program progress and provide senior management with timely updates on scope, resource needs, metrics, and status.
  • Ensure trial adherence to ICH/GCP, federal, local regulations, and company SOPs.
  • Develop, review, and consult on clinical trial documents, including protocols, informed consent, Investigator Brochures, and CSR updates.
  • Own program-level budgeting, forecasting, accrual management, and quarterly budget reviews.
  • Lead vendor and CRO selection, governance, oversight, contract execution, and performance management.
  • Oversee study start-up, closeout, TMF completeness, inspection readiness, and quality/audit response.
  • Work with Biometrics, Pharmacovigilance, Clinical Supply, and CRO partners to oversee data cleaning, supply planning, and drug accountability.

Requirements

  • BA/BS in life sciences or equivalent.
  • Minimum 20 years of clinical research experience.
  • At least 5 years leading global projects from inception to completion.
  • Minimum 7 years of line management experience.
  • Minimum 3 years of biotech industry experience strongly preferred.
  • Significant knowledge of pharmaceutical industry, drug development, and regulatory processes.
  • Experience developing clinical trial plans, including site management, risk mitigation, recruitment, and retention plans.
  • Strong project management skills with proven ability to deliver trials within budgets, timelines, and compliance guidelines.
  • Experience serving on governance committees and managing CROs or other vendors.
  • Strong negotiation, conflict resolution, and financial acumen.
  • Excellent communication skills and ability to present to diverse stakeholders.
  • Ability to work in a fast-paced environment and manage changing priorities.
  • Approximately 30% travel required, including mandatory in-person All Hands meetings and possible travel to San Francisco for Phase 3 planning meetings.

Benefits

  • Market-competitive compensation with a base salary of $285,000-$320,000 per year.
  • Performance bonus opportunity.
  • Equity grant opportunities.
  • Health, welfare, and retirement benefits.
  • Three weeks of PTO, plus two one-week company-wide shutdowns per year and dedicated paid sick leave.
  • Fully remote work environment.
  • Access to professional development resources and growth support.

Interested in this position?

Apply directly on the company website

Apply Now

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