Global Study Director, Biopharmaceuticals
AstraZeneca is a global, innovation-driven Biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious disease. But we’re more than one of the world’s leading pharmaceutical companies.
At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development.
Headquartered in Mississauga, Ontario, we’ve been recognized as one of Greater Toronto Area’s Top Employers for 8 straight years. Our collaborative work environment fosters knowledge-sharing, decision-making, and entrepreneurial thinking. Our employees have the opportunity to work across teams, functions, and even the globe. With a commitment to sustainability, we’re working towards making a meaningful impact where society needs it — health. We know the health of people, the planet and our business are interconnected, each impacting the others.
Our dynamic culture truly sets us apart. We support our people every day, focusing on three priorities: employee growth & development, health & wellbeing, and cultivating a vibrant, engaged and energized workplace. Through practical tools, resources, inspiring learning opportunities, and health and wellness support, we are helping our people thrive at work and beyond.
Our Biopharmaceuticals Research and Development Team:
Join the team unlocking the power of what science can do. We are working towards treating, preventing, modifying and even curing some of the world’s most complex diseases. Here we have the potential to grow our pipeline and positively impact the lives of billions of patients around the world.
Thrive in a place where the brightest and most curious minds seamlessly come together in our inclusive environment.
What you’ll do:
The Global Study Director is a business-critical role within Study Management Late, Biopharmaceuticals whose main accountability is the operational design, planning and delivery of high priority and complex clinical studies within a program, or across multiple studies in a program and/or therapy area that are deemed most critical to the business.
As a Global Study Director, you are responsible for leading a cross-functional study team (core and extended) and for providing the team with direction and guidance to enable successful study delivery. In addition, when working across a program/therapy area, the Global Study Director will provide guidance and support synergistic ways of working across all studies within the program.
You may provide input to early study planning activities based on operational expertise and are accountable for the delivery of studies by ensuring an effective partnership and teamwork within the study team.
Lead and coordinate a team of experts in accordance with the study team operating model and its roles, accountabilities and responsibilities framework (RACI) to ensure the clinical study progress as planned driving achievement of timelines, budget and quality standards
Contribute to vendor/external service provider selection activities at the study level, including bid defense, and lead operational oversight
Assist the Senior Director Study Management with planning for upcoming clinical studies
Collaborate with other functions to establish strategies and identify common practices aimed at increasing efficiency of global study teams
Lead and facilitate communication across functions and provide guidance to study team members as needed
For outsourced studies, be the primary AZ point of contact for the CRO Study Manager to ensure study delivery, while ensuring that the appropriate level of oversight of the CRO is maintained and documented throughout the lifecycle of the study, following relevant AZ SOPs and guidelines (e.g. description of services and transfer of obligations)
Provide operational expertise into and hold accountability for the development of essential study level documents (i.e. Clinical Study Protocol (CSP) through to Clinical Study Report (CSR)
Ensure all external service providers (i.e. central laboratories, IXRS, ePRO, etc.) engaged are performing to contracted goals and timelines/budget and that adequate oversight is documented through planning & control activities
Develop and maintain relevant study plans including required input into study level quality and risk management planning with risk response strategies and clear issue resolution pathways
Oversee study level performance against agreed upon plans, timelines and key performance indicators (quality and operational) by using company tracking systems and project timelines, while communicating any risks to timelines and/or quality, along with proposed mitigations
Identify and report quality issues that have occurred and collaborate with all functions as necessary to overcome barriers and achieve desired outcomes
Oversee Trial Master File (TMF) completion including ensuring the TMF plan and Expected Document List are in place and that QC activities are performed on an ongoing basis
Ensure timely compliance with company-wide governance controls (e.g. Delegation of Authority, Sunshine Act, budget attestations, Clinical Trial Transparency)
Responsible for study budget re-forecasting following initial budget estimate provided by the Clinical Program Team and accountable for budget management through the study lifecycle
Ensure studies are inspection-ready at all times, according to ICH-GCP and AZ SOP and relevant policies/guidelines
Support professional development of team by providing regular feedback on individual performance
Provide guidance, training, expertise, mentoring and support to less experienced study management colleagues
Leads non-drug project work such as SMO representative in process improvements and/or leading improvement projects as discussed and agreed upon with their manager
Collect and report Adverse Events in accordance with AstraZeneca policies and procedures
University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research
Previous global project management experience and training
At least 7 years of clinical trial experience
At least 3 years of experience in global study leadership and team leadership
Extensive knowledge of ICH-GCP guidelines and clinical research regulatory requirements and experience in all phases of clinical study delivery; start up, maintenance and close out.
Thorough understanding of the cross-functional clinical trial process e.g. Data flow
Skills & Capabilities:
Strong strategic and critical thinking abilities
Proven skillset and abilities to solve complex problems and make strong decisions
Strong abilities in establishing and maintaining effective working relationships with strong conflict management skills
Demonstrated abilities in mentoring
Excellent communication and interpersonal skills
Ability to lead multiple challenging priorities
Experience in external provider oversight and management
Great People want to Work with us! Find out why:
GTAA Top Employer Award for 8 years: https://reviews.canadastop100.com/top-employer-astrazeneca-canada
Best Workplace Culture Award at the 2018 Canadian HR Awards: https://www.linkedin.com/pulse/thriving-best-workplace-culture-gena-restivo/
Browse AstraZeneca's YouTube channel to find out more about us: www.youtube.com/user/astrazeneca
Are you interested in working at AZ, apply today!
AstraZeneca is committed to taking every reasonable precaution to protect employees, our customers and the healthcare systems in the communities in which we serve. In an effort to protect the wellbeing of our employees and customers, full COVID-19 vaccination is an essential requirement of all positions at AstraZeneca. As such, all offers of employment will be conditional upon either (i) proof of full COVID-19 vaccination or (ii) proof of need for accommodation under relevant human rights legislation, and AstraZeneca’s determination that the requested accommodation can be provided without undue hardship. You will be required to submit proof of full vaccination or proof of need for accommodation during our background screening process.
AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination.
AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing AZCHumanResources@astrazeneca.com.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.