Clinical Trial Lead

Job Description

Astellas Canada – Clinical Trial Lead

At Astellas, we strive to become a cutting-edge, value-driven life science innovator. This means working at the forefront of healthcare change to turn innovative science into VALUE for patients.

What sets us apart is our focus on patients, our pioneering innovation, our collaborative culture, and the passion of our talented people.

Making a positive impact on patients’ lives is the purpose behind everything we do. At Astellas, we are relentless in our pursuit of scientific progress and in tackling unmet medical needs, demonstrated by our legacy in oncology, overactive bladder and transplant and our impressive pipeline in women's health, blindness and regeneration, genetic regulation, immuno-oncology, mitochondria and targeted protein degradation.

About Us

We are a global pharmaceutical company headquartered in Japan, with a team of more than 14,000 managing operations in approximately 70 countries around the world. We are in the Top 30 global biopharma company based on global revenues and are predicted to be one of the Top 10 Cancer Drug Makers of 2024 by Fierce Pharma.

In Canada, we are growing to meet the exciting opportunities realized by our legacy brands and rich pipeline of innovative treatments.

We are looking for candidates who will thrive in our entrepreneurial and empowering environment where talent and leadership flourish. Do your values align with our Astellas Way - patient focus, ownership, results, openness, and integrity? Then we would love to hear from you.

From the first day in role, everyone at Astellas has a responsibility for creating a brighter future for patients around the world. We nurture exceptional relationships with our employees to allow them to thrive, foster innovation, and deliver exceptional business results. We work to create a culture where our people feel empowered to pursue brave ideas and ambitious outcomes, to have the confidence to be accountable for a higher standard of performance and embody a competitive and solutions-oriented mindset.

Our expertise, science and technology make us a pharma company. Our open and diverse culture is what makes us uniquely Astellas.

Astellas Pharma Canada (APCA) is currently searching for a Clinical Trial Lead.

Description:

• This position is accountable 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 Operations Lead and will lead the cross-functional clinical extended team to ensure efficient and compliant clinical trial set-up, execution and delivery of assigned trials. This includes vendor selection, implementation and oversight of all trial-related processes and plans in support of protocol execution and mentoring and coaching of clinical staff during execution of development trials.
• Individuals may serve in regional capacity to represent Clinical Operations in Key Opinion Leader (KOL) interactions, communications; Interactions and submissions to Health Authorities within their region/country of responsibility. In these cases, they are accountable to the asset team for relevant feedback/input.
• This position may be responsible for managing one or more trials and is accountable for the effective management and oversight of clinical trial budgets, timelines and resources to meet the defined deliverables.
• Represents pre/post-POC Clinical Operations at clinical extended teams or equivalent, portfolio and operational review meetings, primary focus area governance, and cross-functional process improvement projects, as applicable.

Essential Job Duties:

• Manage and lead the day-to-day operations of assigned trials to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements
• Manage and lead cross-functional trial teams, including vendor set-up, performance oversight and closeout activities Responsible for oversight and guidance to clinical study team members in completing deliverables according to agreed timelines and quality standards, including awareness and escalation of high impact quality-related topics for assigned studies
• Ensure set-up and implementation of effective investigator and site monitor training; coordinate operational and therapeutic area training for internal and external trial team members Lead or oversee development of core study documents, study plans and systems set-up to ensure operational excellence in execution of the clinical trial protocol and quality across investigative sites, vendors and data
• Proactively identify and resolve issues that arise during trial conduct; manage escalation of trial-related issues, internally and externally
• Provide input on clinical operational/development matters for interactions with regulatory authorities and key opinion leaders, either globally or regionally
• Lead preparation of vendor requirements and assess vendor capabilities to support trial scope and selection of qualified vendors; effectively manage interactions with vendor project management team Lead feasibility assessment and selection of countries and sites for trial conduct
• Facilitates site engagement and communications with investigators and/or staff to support study milestones and deliverables Participates in and/or facilitates cross-functional collaboration and strategic problem solving to ensure risk mitigation, appropriate progress and timely completion of trials and deliverables according to established objectives, milestones and goals
• Provide accurate and up-to-date trial information in relevant tracking systems and provide regular updates of trial progression to the Clinical Operations Lead and other defined stakeholders Participates in inspection readiness activities including coordination of clinical study team deliverables
• Individuals may serve in regional capacity to represent Clinical Operations in submissions and interactions with Health Authorities or other (external) activities as applicable
• Individuals may provide regional clinical strategies directly or indirectly to asset team, in collaboration with clinical operations lead, to optimize global development strategy Facilitate and manage regional KOL interactions, as applicable
• Oversee the clinical aspects of timely data cleaning, data analysis and the availability of top line results; support development of data review plans, review of statistical analysis plans and participate in data reviews and manage data findings
• Participate in process improvement and quality-related initiatives associated with trial execution and deliverables; participate in establishment of best-in-class processes and standards for trial conduct
• Provide oversight and direction to trial team members for trial deliverables, including ensuring the evaluation and implementation of patient-focused strategies for assigned trials, globally and regionally, as appropriate
• Performs other duties as assigned or special projects as needed.

Requirements

Required Qualifications:

• BA/BS degree with at least 5 years clinical trial experience or advanced degree (MS/PhD/PharmD) with at least 3 years clinical trial experience
• Must have strong oncology study execution experience (early phase experience highly preferred)
• Must have strong knowledge of ICH/GCP guidelines and regulatory requirements
• Must have strong knowledge of protocol and clinical drug development processes, clinical trial design, trial
• planning and management, and monitoring
• Requires proven project management skills and trial leadership ability
• Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer
• ability
• Fluent in English
• Moderate (~25%) travel required

Preferred Qualifications:

• Advanced Degree

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.

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.

No telephone inquiries, in-person applications, or agencies please. While we appreciate all applications, only candidates under consideration will be contacted.