Director, Business Enablement Lead

The Development Operations Business Enablement department is responsible for leading all aspects of activities critical to the seamless operation of Development Operations. This encompasses various areas of Operational Excellence, including Quality & Compliance, Process Management and Strategic Sourcing. As Director, Business Enablement Lead, your role encompasses leading or contributing to comprehensive Development Operations strategies. You'll be responsible for successfully delivering complex projects and engaging with external partners. Sharing your valuable insights and experiences proactively with colleagues, both within and outside the organization, is a key aspect. Moreover, your active involvement in industry-wide initiatives is pivotal, using your expertise to drive progress and set new standards within the field. You are responsible for driving process effectiveness and efficiency for Development Operations in the areas of Operational Excellence and Strategic Sourcing.

You will be responsible for:
• Collaboration with peers across Development Operations function, and cross-functionally throughout the organization, and industry to identify, design and deliver appropriate Clinical Operations and/or Data Management solutions and process improvements.
• Critical thinking, collaboration, communication skills, and an entrepreneurial mindset to innovate Clinical Operations and/or Data Management processes and ensure the development and delivery of medicines for our patients.
• Proactively identify gaps and lead functional/cross-functional/R&D-wide/industry initiatives or goals to promote new ways of working, including emerging technologies. Enable broader and more effective use of data, tools and systems to support the business.
• Offer guidance and advice to peers within the function, to key partners and to FSPs, CRO and collaborative groups on technical solutions to ensure high quality portfolio delivery. Deliver solutions as needed.
• Acting as the process owner for one or more critical Development Operations processes ensuring they remain current and reflective of our evolving ways of working and regulatory requirements.
• Contribute to strategic direction by applying highly developed levels of conceptual thought and strategic vision to manage the highest level of risk.
• Drive process improvements and standardization initiatives to enhance operational efficiency.
• Reinforce quality mentality across Development Operations & support inspection readiness efforts within functions, may participate in quality audits as required.
• Participate in and or lead strategic departmental initiatives.
• Act as process owner for critical development operations, ensuring seamless execution and compliance.

You will need to have:
• Bachelors’ degree or equivalent in clinical practice/healthcare, life sciences, or drug development.
• >10 years of clinical research experience in the pharmaceutical industry.
• Expert knowledge of clinical operations and/or data management, and drug development processes.
• Project and change management experience demonstrated in drug and/or non-drug projects.
• Knowledge of regulatory requirements for the conduct of clinical trials.
• Demonstrated ability to lead complex projects and manage multiple priorities effectively.
• Excellent problem-solving skills with ability to address complex, abstract challenges.
• Exceptional written and verbal communication skills.
• Advanced ability to work in a matrix environment and develop constructive partnerships.
• Experience coaching/mentoring/managing junior team members.
• The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

We would prefer for you to have:
• Experience in contributing/participating to industry wide initiatives, such as TransCelerate.
• Line management experience would be an asset.

Alexion Canada

Since beginning our operations in Canada in 2009, Alexion has been working tirelessly to bring innovative medicines to the millions of Canadians living with rare diseases. Our pioneering 30-year legacy, our scientific expertise and our commitment to patient-centric decision-making are the foundations of what we are today – a company with a mission to transform lives.

Our Canadian team

We know that people living with a rare disease and their families deserve our unwavering commitment and investment into finding and accessing therapies that help them live longer, fuller lives. Our presence in Canada has grown to over 200 employees and includes a global research and development hub, made up of highly skilled professionals responsible for conducting our clinical trials in Canada and around the world, as well as our dedicated and passionate local teams that ensures our treatments reach those who need them. Together, we are driving patient impact locally and globally.

How we work
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

Alexion 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 authorization and employment eligibility verification requirements. Alexion 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.

#Li-Hybrid

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 authorization and employment eligibility verification requirements.