Astellas Pharma · 8 hours ago
Site Management Lead (Associate Director)
Northbrook, IL
Full-time
Hybrid
Senior Level, Lead/Staff, Director/Executive
$141K/yr - $222K/yr
10+ years expAstellas Pharma is a global pharmaceutical company dedicated to developing innovative therapies for patients. The Site Management Lead is responsible for managing clinical trial staff, ensuring operational excellence in clinical trials, and providing leadership and mentorship to enhance individual development in site monitoring and management.
BiotechnologyHealth CareMedical
Responsibilities
Accountable for the identification, onboarding, training and development of monitoring clinical trial talent to support the planning, initiation, execution and close-out of clinical trials with operational excellence
Responsible for resource planning, recruitment, mentoring, development and retention of site monitoring & management staff
Manage and allocate monitoring resources to trials and monitor performance on assigned trials for monitoring staff (up to 12 direct reports)
May manage and allocate monitoring resources in more than one region globally
Provides direction, leadership and learning opportunities to enhance individual development of direct reports in support of providing best-in-class site monitoring across the portfolio
Provide oversight and guidance in completing monitoring and site management related activities according to agreed timelines and quality standards, including identifying areas for additional training and development
Oversee adherence to timelines, standards, processes for work assigned to their staff
Serves as a point of escalation for clinical monitoring/site management related topics or issues from their staff
Oversee and provide guidance to Clinical Operations Leads and/or Clinical Trial Leads in regional Key Opinion Leader (KOL) interactions, communications; and submissions to Health Authorities within their region/country of responsibility, aligned to the overall asset strategy
Responsible for compliance of direct reports with training and identification and support for any training needs
Facilitate and support global trial monitoring operational standards and tools
Anticipates, recognizes and facilitates problem solving to support site monitoring & management staff and rapidly addresses and mitigates potential performance issues
Collaborates effectively with Portfolio Operations Leads, Clinical Operations Leads and SORD leadership to ensure site monitoring & management staff are delivering as expected and to ensure common framework and standards across clinical programs and trials
Ability to collaborate with peers in Clinical Operations across Early and Late-Stage Clinical Operations, cross-functionally and regionally, including relevant counterparts globally, to align on best practices for clinical monitoring staff
May lead process improvements relevant to clinical trial monitoring and site management
Contribute to development and implementation of best-in-class monitoring/site management standards and processes
Qualification
Required
BA/BS degree with at least 10 years of executing global drug development programs and trials
Minimum of 4 years' site monitoring and direct people management experience
Demonstrated leadership skills and ability to effectively collaborate with colleagues in Clinical Operations and cross-functionally to deliver on portfolio deliverables and objectives
Must have extensive expertise in risk-based monitoring strategies and strong knowledge of ICH/ GCP guidelines and multinational clinical trial regulations
Must have experience working across multiple phases of development and in multiple therapeutic areas
Demonstrated ability to successfully identify and lead global processes or system improvement initiatives
Must have a strong knowledge of clinical development processes and conducting global clinical programs
Must have proven leadership skills and effective written and verbal communication skills
Fluent in English. Depending on hiring region, may also be required to be fluent in local language
Moderate (up to 30%) travel required
Preferred
Advanced Degree
Benefits
Medical, Dental and Vision Insurance
Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
401(k) match and annual company contribution
Company paid life insurance
Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
Long Term Incentive Plan for eligible positions
Company-paid fleet vehicle for eligible positions
Referral bonus program
Company
Astellas Pharma
Astellas Pharma is a global pharmaceutical research & development company.
10001+ employees
H1B Sponsorship
Astellas Pharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (7)
2024 (4)
2023 (4)
2022 (2)
2021 (3)
2020 (5)
Funding
Current Stage
Public CompanyTotal Funding
unknownKey Investors
National Institute on Drug Abuse (NIDA)
2020-07-22Grant
2008-10-13IPO
Leadership Team
Amanda Hart
Head, Global Commercial Analytics and Reporting
Recent News
2025-12-18
2025-12-17
Company data provided by crunchbase