Associate Director SMM

Would you like to apply your expertise to make an impact in a company that follows the science and turns ideas into life-changing medicines? Then AstraZeneca might be the one for you!

At AstraZeneca we believe in the potential of our people and you’ll develop beyond what you thought possible. We make the most of your skills and passion by actively supporting you to see what you can achieve no matter where you start with us.

Welcome to Basiglio (Milan), one of over 400 sites here at AstraZeneca. The site provides a collaborative environment where everyone feels comfortable and able to be themselves, which is at the core of AstraZeneca’s priorities.

As a global science-led biopharmaceutical company, everything we do comes back to improving the health of our patients worldwide. We seek out new opportunities to do dynamic and significant work, and we encourage our people to continually foster new insights to find different ways of building ground-breaking medicines. This is why, today, we have an unparalleled product portfolio in Oncology, Respiratory and Cardio-Renal Metabolic diseases.

The future of treatment for many of today’s diseases lies in uncovering mechanisms that are newly emerging or are still to be discovered. We believe the best way to help patients is to focus on breakthrough science to discover these mechanisms and develop novel, targeted therapies that interact with them.

As Associate Director SMM you will provide technical leadership as an expert lead of clinical studies to ensure effective collaboration between the project teams.

MAIN DUTIES AND RESPONSIBILITIES

Reporting to the SMM Oncology Lead, as Associate Director SMM (ADSMM) you will be accountable for delivering the committed part of all clinical interventional studies according to agreed resources, budget and timelines complying with AZ Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations.

The role broadly includes the following responsibilities:

• Line managing dedicated group(s) of staff and responsible for planning and utilization of staff resources, assigned budget, objective setting and performance follow-up.  

• Leadership of dedicated group, building the team spirit, developing team style and behaviour
• Ensuring adequate resources for the studies assigned and that the workload of direct reports is adequate
• Development and performance management of direct reports, according to IDP process
• Coaching the direct reports on a regular basis, with external providers if needed.
• Preparing salary and bonus proposals for direct reports based on their performance in close collaboration with responsible SMM Onco Lead and local HRBP
• Contributing to efficient SMM organisation and its functioning at country level by working closely with responsible SMM Onco Lead
• Overseeing successful delivery of SMM Oncology study delivery country level targets to plan, with speed and quality
• Contributing to the quality improvement of the study processes and other procedures
• Ensuring completeness and timeliness of the eTMF to maintain it “Inspection Ready” and continuous updating of systems
• Assisting SMM Onco Lead or Local Study Managers/teams in forecasting study timelines, resources, recruitment, study materials and drugs
• Providing direction to LSM/teams on major study commitments including resolving any key issues identified
• Ensuring collaboration with local Medical Affairs team
• Supports SMM region in initiatives/activities as agreed with SMM Onco Lead.
• Reviewing SQV reports of direct reports in line with AZ SOPs
• Reviewing Accompanied site visits/co- monitoring visits/training visits/QC visits performed to direct reports in line with the local QC plans.
• Manage all activities and Account relationship according with Company Values, Code of Conduct, Guidelines/Internal procedures and Italian legislation.

REQUIREMENTS

• Bachelor’s degree in related discipline, preferably in life science, or equivalent qualification.
• Minimum 5 years of experience in Development Operations (CRA / Sr. CRA / LSM) or other related fields.
• Excellent interpersonal skills.
• Manage change with a positive approach for self, team and business. Sees change as an opportunity to improve performance and add value to business.
• Proven project management experience.
• Excellent organisational, analytical, influencing and negotiation skills.
• Excellent presentation and communication skills, verbal and written.
• Excellent knowledge of spoken and written English.
• Excellent knowledge of the Monitoring Process
• Good understanding of the Study Drug Handling Process and the Data Management Process. 
• Good knowledge of relevant local and international regulations.
• Good medical knowledge and ability to learn relevant AZ therapeutic areas
• Good ability to learn and to adapt to work with IT systems.
• Ability for national and international travel.

DESIRABLE REQUIREMENTS

• Experience in global roles in the Site Management and Monitoring area
• Experience of working in an environment of remote collaborators
• Good financial management skills

Why AstraZeneca?

At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. We’re opening new ways to work, pioneering ground-breaking methods and bringing unexpected teams together. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be.

Next Steps – Apply today!

To be considered for this exciting opportunity, please complete the full application.

The recruitment team will evaluate your profile and review your CV to determine whether your skills and experience match the job profile.

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Date Posted

Closing Date

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.