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Senior Director, Study Management Late Oncology

Location Mississauga, Ontario, Canada Job ID R-121160 Date posted 07/10/2021

About AstraZeneca:

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.

AstraZeneca Canada:

Headquartered in Mississauga, Ontario, we’ve been recognized as one of Greater Toronto Area’s Top Employers for 7 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 Oncology Research and Development Team:

Oncology is driven by speed. Here you will be backed by leadership and empowered at every level to prioritize and make bold moves. Our pioneering approach is identifying and treating patients earlier, focusing on early stage cancer trials and listening and evolving based on their needs.

Join a dedicated Oncology team that’s growing fast and building a strong track record of success. We make bold moves at the cutting-edge. Transforming molecules to change the practice of medicine.  

Location: Mississauga, Ontario (Head office based position)

Role Description:

The Senior Director, Study Management (SDSM) Late-stage Oncology will strengthen our TA alignment. This role combines deep TA/tumor knowledge, combined with strong leadership and excellent partner management, to build and implement strategies to achieve excellence in an aligned organization concentrating on Oncology focus areas to optimally deliver our clinical studies.

As a SDSM, you develop strategy and tactics to deliver studies within a therapeutic area in a consistent and efficient way, and ensure sharing of knowledge and TA upskilling across resources allocated to the projects within the therapeutic area of your responsibility.

Additionally, the SDSM will take a senior leadership role for hub related initiatives in and across locations.

What you'll do:

  • You will collaborate with Director Clinical Development (DCD)/Associate Director Clinical Development (ADCD) and Directors, Study Management (DSM),  accountable for timely, within budget and quality delivery of studies from Study Hand-over to Clinical Study Report.

  • You will ensure right level of TA expertise and knowledge sharing and consistent ways of working across study management teams working within aligned TA, and across Oncology and other TAs.

  • You will be the main point of contact for DCD/ADCDs and other partners within assigned TA to ensure Study Management has a good understanding of the TA priorities, is aligned strategically and has a shared vision with TA project team.  Additionally, this role will share their insights with the project team (DCD/ADCD).

  • You provide strategic leadership to the Study Management organization (SMO) in the assigned therapeutic area to drive projects and performance.

  • You work together with the Early Oncology leadership as appropriate

  • You are the point of escalation for quality issues and inspection readiness

  • You act as a study management resource to DCDs/ADCDs during the New Opportunity planning and governance phase.

  • You support delivery, as appropriate, through the submission and approval phase of a project

As member of Study Management Leadership Team :

  • You work with closely with the Leadership Team, responsible for timely and high-quality delivery of the studies assigned to Study Management late Oncology

  • You drive an environment of global standardization and continuous improvement

  • You help develop and maintain global operational delivery models and mid and long-term strategic workforce planning

  • With other members of the Leadership team and key customers, you develop and deliver performance targets and metrics for the operational study delivery ensuring effective risk planning and open visibility of issues escalation pathway

  • You ensure the SMO has the capability and resources required to deliver assigned studies, and build Study Management capability and organization for the future

  • You drive and create a culture that feeds courageous, entrepreneurial, creative and coordinated behaviors

  • You contribute to the overall late Oncology performance

  • You lead a significant project or non- drug project deliverables that contribute to overall AZ business success

  • You may be responsible for the role of the location lead for study management to collaborate with significant local departments - HR, Finance, IT, compliance, facility management which is needed for the maintenance of the organization and determination of local budget

As a Functional Manager:

  • You attract, recruit, develop & retain top talent

  • You lead and support change

  • You develop, coach, mentor, motivate and support SMO employees to achieve their fullest potential

  • You ensure performance management and personal development of employees

  • You comply to ethics, policies and standard procedures

  • You are the line manager of the Associate Directors Study Management

Essentials for the role:

  • University degree MSc or equivalent preferably in life science

  • At least 5 years’ experience in study management including 3 years in assigned TA

  • At least 10 years Pharmaceutical Industry experience in Clinical Development and Study Operations

  • Comprehensive knowledge of clinical and pharmaceutical drug development process with at least 10 year’s experience in this area.

  • Excellent stakeholder management skills

  • Validated line management and leadership expertise, with at least 3 years experience as a line manager

  • Shown development of others, identifying and providing opportunities to improve the capabilities of other people

  • Risk and crisis management experience

  • Background of high professional achievement and willingness to bring this out in others

  • Leads change with a positive approach to the challenges of change for self, team and the business. Sees change as an opportunity to improve performance and make valuable contributions to the business

  • Ability to set and run priorities, resources, performance targets and project initiatives in a global environment

  • Ethics: Maintains high standards, including a commitment to AstraZeneca values, policies, and employment principles and policies.

  • Cultural Awareness: Is aware of and sensitive to cultural differences and their impact on communication, expectations and performance.

  • Effective in leading and being a member of teams, both locally and internationally.

Are you interested in working at AZ? Apply today

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager will know that you feel well qualified for this position. If you know someone who would excel in this position, we invite you to share this posting with them.

AstraZeneca is an equal opportunity employer. We will consider all applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.

Extraordinary People want to Work with us, find out why:

  • We are GTAA's Top Employer Award for 5 years:

  • We received Best Workplace Culture Award at the 2018 Canadian HR Awards:

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, 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

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.

10000930 G CDSM R&D Oncology (Susan Galbraith (07016555)) (85008610)

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Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.