Director, Site Management And Monitoring

At Astellas, we’re united by a single purpose: to positively impact patients’ lives by
turning innovative science into value for patients and improving their health. Our patient-
focused approach drives our strategic thinking and informs our day-to-day decision-
making.
You’ll thrive at Astellas Canada if you share this purpose and want to do meaningful
work. We’re proud of our company culture and how it sets us apart. We support our
people as much as our patients, offering an open, inclusive and welcoming environment.
As a global organization we are collaborators who work with accountability and integrity.
Together, we create innovative treatments that improve patients’ lives now, and in the
future. For more information on Astellas Canada, please visit our website
www.astellas.ca
We are currently searching for a Director, Site Management and Monitoring reporting to
the Early Development Clinical Operations Head. This role is a home-based position.
Potential candidates must reside in the province of Ontario with a preference for the
Greater Toronto and surrounding areas.
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. Individuals in this role will also provide
leadership/mentorship, in a matrix setting, for activities that support clinical trial teams.
This position is accountable to the Portfolio Operations Lead, Business Strategy Lead or
above and will provide input into departmental budget and resourcing strategies, including
development and implementation of global processes and procedures, non-drug product
initiatives, and coaching of monitoring staff during execution of development trials.

Essential Job Duties

Responsible for resource planning, recruitment, mentoring, development and
retention of monitoring staff.

Manage and allocate monitoring resources to trials and monitor performance on
assigned trials for monitoring staff

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 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 monitoring staff

and rapidly address and mitigate potential performance issues
Collaborates effectively with portfolio operations Leads, clinical operations leads,

Center of Excellence and PECs leadership to ensure monitoring 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

Identifies, escalates, and facilitates process improvements relevant to clinical trial
monitoring

Contribute to development and implementation of best in class monitoring standards
and processes.

Required 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 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 process 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
Moderate (~30%) travel

Preferred Qualifications
Advanced Degree

Additional Information
Astellas Pharma Canada welcomes and encourages applications from people with
disabilities. Accommodations are available on request for candidates taking part in all
aspects of the hiring process.
Astellas Pharma Canada requires full Vaccination against COVID-19 as a condition of
employment. Reasonable accommodation to this policy may be granted for a valid
accommodation request under human rights legislation. An individual is considered to be
“fully vaccinated” two weeks or more after the receipt of the second dose in a two-dose
Vaccine or one dose of a single-dose Vaccine, or if the individual is otherwise considered to
be Fully Vaccinated by the government of the province in which they are employed.
If booster shots are required by a relevant Canadian public health authority (with
requirements varying potentially based on the Vaccine), “fully vaccinated” should be
interpreted to mean fully compliant with any such recommendations within a reasonable
amount of time-based on the accessibility and availability of the booster shots.
Application Procedure
If your skills and experience match our needs, please email your resume to:
employment@astellas.com.
Please indicate position applied to in your application.
No telephone inquiries, in-person applications, or agencies please. While we appreciate
all applications, only candidates under consideration will be contacted.