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Associate Director, Clinical Operations Standards and Planning

2 hours, 56 minutes ago
United States
Full-time
Lead
Operations 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 17

Description

  • Identify, document, maintain, and optimize clinical operations standards and best practices across global clinical trials.
  • Lead efforts to improve operational efficiency across clinical programs by partnering with CROs, vendors, and internal stakeholders.
  • Oversee clinical operations resource planning and management to ensure resources are available at the right time and used efficiently.
  • Maintain consistent operational standards across programs and studies, including study-level standardization and inspection readiness.
  • Collaborate with Process Excellence, QA, and cross-functional study teams to develop standardized processes, tools, and resources.
  • Develop, coordinate, and maintain best practices for clinical operations activities to support sponsor-of-choice objectives globally.
  • Work with clinical study teams and CROs to establish country-specific operational practices that meet local requirements.
  • Lead and participate in process improvement initiatives to drive continuous improvement and operational excellence.
  • Support the Clinical Operations Leadership Team in building and maintaining a defined career ladder for employee growth and organizational scalability.
  • Lead assigned departmental activities to support a high-functioning Clinical Operations organization.

Requirements

  • Bachelor’s degree is required.
  • 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 and other vendors.
  • Experience managing CROs, vendors, and/or clinical trial consultants is preferred.
  • Experience driving innovation in clinical trial operations and implementing best practices.
  • Strong leadership, communication, and interpersonal skills with the ability to influence cross-functional teams at all levels.
  • Deep knowledge of drug development processes, ICH-GCP guidelines, 21 CFR Part 11, and major Health Authority regulations.
  • Strong project management skills and effective matrix leadership capabilities.
  • Analytical and forecasting experience, including capacity modeling, utilization optimization, and data-driven decision-making.
  • Ability to thrive in a fast-paced, dynamic, high-growth environment.
  • Willingness and ability to travel up to 30% of the time.

Benefits

  • Annual salary range of $175,000 to $195,000.
  • Market-competitive compensation package with performance bonus opportunities.
  • Equity grant opportunities.
  • Health, welfare, and retirement benefits.
  • Three weeks of PTO, plus two one-week company-wide shutdowns each year and paid sick leave.
  • Professional development support and access to growth resources.
  • Regular all-team in-person meetings to build relationships and solve problems.
  • Opportunity to work in a fast-paced environment with a strong C.O.R.E. culture.

Interested in this position?

Apply directly on the company website

Apply Now

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