Site Management Lead; Associate Director

Site Management Lead (Associate Director)

Join to apply for the Site Management Lead (Associate Director) role at Astellas Pharma

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world.

For more information on Astellas, please visit our website at

This position is accountable for the direct management of assigned monitoring/site management related clinical trial staff across all clinical trial types, which may include pre/post-POC interventional drug trials, Clinical Pharmacology normal healthy volunteer clinical trials, pre-approval access and post-marketing regulatory commitment trials (interventional and non-interventional).

• 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.
• Provide leadership/mentorship in a matrix setting for activities that support clinical trial teams.
• Accountable to the Head, Clinical Site Management Early Development, and provide input into departmental budget and resourcing strategies.
• Develop and implement global processes and procedures, non‑drug product initiatives, and coach monitoring staff during execution of development trials.
• 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.
• Provide direction, leadership and learning opportunities to enhance individual development of direct reports.
• Provide oversight and guidance in completing monitoring and site management activities according to agreed timelines and quality standards.
• Ensure adherence to timelines, standards, and processes for work assigned to staff.
• Serve as a point of escalation for monitoring/site management related topics or issues from 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.
• Ensure compliance of direct reports with training and identification and support for any training needs.
• Facilitate and support global trial monitoring operational standards and tools.
• Anticipate, recognize, and facilitate problem solving to support site monitoring & management staff and rapidly address and mitigate potential performance issues.
• Collaborate effectively with Portfolio Operations Leads, Clinical Operations Leads, and SORD leadership.
• Collaborate with peers in Clinical Operations across Early and Late-Stage Clinical Operations, cross‑functionally and regionally, including relevant counterparts globally.
• 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.

• 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.
• Extensive expertise in risk‑based monitoring strategies and strong knowledge of…