Job Description

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 www.astellas.com .


This position is based in Ontario, Canada. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.

Purpose and Scope:

This position is responsible to support or lead specific activities for the planning, set-up and execution of assigned drug trials 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).


This position is accountable to the Clinical Trial Lead and Operations Lead for trial execution and works collaboratively with cross-functional team members and vendors to ensure proper set-up of trial processes and plans to execute the protocol with operational excellence and in accordance with SOPs and standards to ensure quality of trial deliverables

Essential Job Responsibilities:

Manage the day-to-day operations of assigned trials and responsibilities to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements



Leads or supports cross-functional trial teams, including vendors



Ensures accurate and up-to-date trial information within relevant tracking systems and provide regular updates of trial progression to Clinical Operations Lead, Clinical Trial Lead, and other defined stakeholders



Proactively identify and resolve issues that arise during trial conduct; manage escalation of trial-related issues



Participate in or lead the development of core trial documents, trial plans and system set-up; participate in preparation and ensure operational excellence of protocol and implementation of appropriate systems, standards, and processes to ensure quality across investigative sites, vendors, and data



Participate in or lead preparation of vendor requirements and project scope and selection of trial vendors; effectively manage interactions and escalations with vendor trial team



Participate in or lead feasibility assessment and selection of countries and sites for trial conduct



Participate in or facilitates site engagement and communications with investigators and/or staff to support trial milestones and deliverables



Oversee the clinical aspects of timely data cleaning, data analysis and the availability of top line results; participate in data reviews and review of statistical analysis plans



Participate in or lead set-up and implementation of effective investigator and site monitor training; coordinate operational and therapeutic area training for internal and external trial team members



Provide oversight and direction to trial team members for trial deliverables



Manage clinical trial budget and associated vendor contracts, including tracking and data in associated systems



Ensure quality and completeness of TMF for assigned clinical trials



Participates in inspection readiness activities including coordination of clinical trial team deliverables



Participate in the evaluation and implementation of patient-focused strategies for assigned trials, as applicable



Responsible for the management of budgets, timelines and resources for assigned clinical trial responsibilities

Qualifications:

Required

BA/BS degree with at least 3 years clinical trial experience or direct equivalent experience or advanced degree (MS/PhD/PharmD) with at least 2 years clinical trial experience



Must have relevant clinical pharmacology/phase I clinical trial experience



Must have strong knowledge of ICH/GCP guidelines and regulatory requirements



Must have knowledge of protocol and clinical drug development processes, clinical trial design, trial planning and management, and monitoring



Requires project management skills and trial leadership ability



Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability



Proficient in English



Moderate (~25%) travel required

Working Environment:

At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas' Responsible Flexibility Guidelines

Benefits:

Medical, Dental and Vision Insurance



Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks



RRSP 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



Referral bonus program



Category Early Development Clinical Operations


Astellas is committed to equality of opportunity in all aspects of employment.


EOE including Disability/Protected Veterans