[Hiring] Clinical Site Management Lead I @Astellas Pharma

Role Description

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.
• Provides leadership/mentorship in a matrix setting for activities that support clinical trial teams.
• Accountable to the Head, Early or Late Stage Site Monitoring & Management.
• Provides input into departmental budget and resourcing strategies.
• Develops and implements global processes and procedures.
• Coaches monitoring staff during execution of development trials.

Responsibilities

• Responsible for resource planning, recruitment, mentoring, development and retention of site monitoring & management staff.
• Manages and allocates monitoring resources to trials and monitors performance on assigned trials for monitoring staff (up to 12 direct reports).
• Provides direction, leadership and learning opportunities to enhance individual development of direct reports.
• Provides oversight and guidance in completing monitoring and site management related activities according to agreed timelines and quality standards.
• Oversees 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.
• Oversees and provides guidance to Clinical Operations Leads and/or Clinical Trial Leads in regional Key Opinion Leader (KOL) interactions.
• Responsible for compliance of direct reports with training and identification and support for any training needs.
• Facilitates and supports global trial monitoring operational standards and tools.
• Anticipates, recognizes and facilitates problem solving to support site monitoring & management staff.
• Collaborates effectively with portfolio operations Leads, clinical operations leads, Center of Excellence and PECs leadership.
• Identifies, escalates, and facilitates process improvements relevant to clinical trial monitoring and site management.
• Contributes to development and implementation of best in class monitoring/site management standards and processes.

Qualifications

• BA/BS degree with at least 8 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.
• Extensive expertise in risk based monitoring strategies and strong knowledge of ICH/GCP guidelines and multinational clinical trial regulations.
• Experience working across multiple phases of development and in multiple therapeutic areas.
• Demonstrated ability to successfully identify and lead global process or system improvement initiatives.
• Strong knowledge of clinical development processes and conducting global clinical programs.
• 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 (~30%) travel required.

Preferred Qualifications

• Advanced Degree.

Location and Working Environment

• Remote work from anywhere in the US is available.
• Hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home.

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 fleet vehicle for eligible positions.
• Referral bonus program.

Salary Range

$144,060 - 205,800 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations)