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Associate Director, Clinical Operations Standards and Planning

3 weeks, 6 days 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 22

Description

  • Identify, document, maintain, and optimize Clinical Operations standards and best practices across global clinical trials.
  • Lead efforts to identify and implement innovative strategies that improve operational efficiency across programs.
  • Oversee Clinical Operations resource planning and management to ensure resources are available when needed.
  • Partner with CROs, vendors, and internal stakeholders to align performance and delivery expectations.
  • Maintain consistency in operationalizing global clinical trials and support inspection readiness.
  • Collaborate with Process Excellence, QA, and Clinical Study Team members to standardize study-level operations and build tools and resources.
  • Develop and maintain operational best practices to support Apogee as a sponsor of choice for clinical trial sites globally.
  • Support the Clinical Operations Leadership Team in building and maintaining a defined career ladder for employee growth.
  • Lead and participate in process improvement initiatives to drive continuous improvement.
  • Lead assigned departmental activities that support a high-functioning Clinical Operations organization.

Requirements

  • Bachelor’s degree required.
  • Minimum 12+ years of pharmaceutical or biotech industry experience in a clinical operations-related role.
  • Experience operationalizing large, global clinical trials.
  • Experience providing oversight of CROs, vendors, and/or clinical trial consultants.
  • Experience driving innovation in clinical trial operations to improve efficiency and implement best practices.
  • Extensive knowledge of drug development processes, ICH-GCP guidelines, 21 CFR Part 11, and major Health Authority regulations.
  • Strong leadership, communication, and interpersonal skills with the ability to influence cross-functional teams at all levels.
  • Strong project management skills and effective matrix leadership experience.
  • Strong analytical and forecasting capabilities, including capacity modeling, utilization optimization, and data-driven decision-making.
  • Ability to thrive in a fast-paced, dynamic, high-growth environment.
  • Up to 30% travel required.

Benefits

  • Anticipated salary range of $175,000 to $195,000 per year.
  • Market-competitive compensation and benefits package with base salary, performance bonus, and equity grant opportunities.
  • Health, welfare, and retirement benefits.
  • Three weeks of PTO, plus two one-week company-wide shutdowns each year.
  • Dedicated paid sick leave.
  • Professional development support and access to resources for growth.
  • Regular all-team in-person meetings to build relationships and solve problems.

Interested in this position?

Apply directly on the company website

Apply Now

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