Site Operations Director - Clinical

Site Operations Director - Clinical

Location: Albany, NY (Relocation package offered)

Annual Site Revenue: ~$30M

Position Summary

The Site Operations Director - Clinical provides strategic, technical, and managerial leadership for site operations. This role is responsible for operational efficiency, regulatory compliance, business growth, and fostering a strong organizational culture. The Site Director oversees all aspects of site performance, ensures a high-performing workforce, and represents the site in leadership forums. The site’s activities are organized into two core areas - Process Sciences and Quality Control - together employing approximately 200 people. The Site Operations Director directly manages six key reports.

Key Responsibilities

Operational Leadership

• Provide overall technical and managerial direction for site operations.
• Lead a team of 200 staff, driving engagement, accountability, and performance.
• Manage day-to-day operations of a ~$30M site while aligning with strategic objectives.
• Represent the site in leadership forums, reporting on operational, financial, and strategic metrics.

Oversee Process Sciences and Quality Control functions:

• Process Sciences:
• Support clinical trial manufacturing and development activities, spanning upstream (cell culture/fermentation) and downstream (purification/recovery) bioprocessing.
• Provide process development support for client-sponsored clinical programs, ensuring scalability, reproducibility, and regulatory compliance.
• Perform data verification and review to safeguard trial-related process data integrity.
• Quality Control (QC):
• Deliver full analytical and release testing to support clinical trial materials, including:
• Microbiology: environmental monitoring, sterility, endotoxin, and bioburden testing
• Raw Material Testing: compliance verification, identity, purity, and safety testing
• Analytical Chemistry: method development, validation, stability testing, impurity profiling
• Sample Management: receipt, chain-of-custody, storage, and logistics for trial-related samples
• Ensure GMP compliance and smooth progression of products through clinical trial phases.

Quality & Compliance

• Ensure adherence to GMP/GLP standards across all functions.
• Oversee compliance with quality systems and site-wide quality policies.
• Identify, prevent, and correct quality system deviations.
• Maintain compliance with federal, state, and corporate regulations.
• Promote safe, efficient, and compliant operations.

Client & Business Development

• Serve as primary contact for client interactions, ensuring superior service delivery.
• Build and maintain strong client and stakeholder relationships.
• Support business growth through consulting, technical input, and protocol review.
• Participate in client site visits and business development initiatives to expand partnerships.

People & Culture

• Recruit, hire, and retain top talent to build a high-performing team.
• Foster collaboration, teamwork, and a client-focused culture.
• Develop staff to ensure succession planning and leadership continuity.
• Drive employee engagement and motivation to support strong retention rates.

Administration & Reporting

• Prepare operational reports, budgets, and performance reviews.
• Present site performance metrics and growth plans in leadership forums.
• Lead strategic planning, financial management, and continuous improvement initiatives.

Qualifications

Experience

• Minimum 10 years of leadership experience within CDMO, CRO, or life sciences industries.
• Proven success managing operations with $30M revenue and 150 FTEs.
• Strong track record in client management and business development.

Success Profile

• Demonstrated ability to manage sites with $20–30M revenue and 50–100 staff.
• Strong leadership skills to ensure operational stability, staff motivation, and growth.
• Experience in CDMO, CRO, or similar organizations (e.g., Parexel, Lonza).
• Innovative, growth-minded leader with a focus on continuous improvement.

Compensation

• Base Salary: $140k–$175k
• Bonus: 30%