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Senior Director, Site Management & Monitoring Oncology, Lung

Location Wilmington, Delaware, United States Job ID R-194713 Date posted 09/06/2024

Introduction to role

Are you ready to make a big impact? Join our dedicated Oncology team that's growing fast and building a strong track record of success. As the Senior Director for Site Management & Monitoring (SMM), you will be accountable for the strategy planning and delivery of oncology clinical interventional studies with a focus in lung cancer. This will be done under your supervision 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 Sr DSMM is responsible for ensuring consistent, transparent communication with key global and local stakeholders including but not limited to Medical Affairs and other Country DSMMs.

Accountabilities

As a Senior Director, you will contribute to global execution strategies and Clin Ops focus areas. You will partner with Late Oncology indication leads and Clinical Development team members, providing insights to DRC and PRC review. You will also lead cross-functional meetings with global and medical affairs. Your role will include oversight of North America patient delivery for lung cancer, leadership of dedicated group, building the team spirit, developing team style and behavior. You will ensure adequate resources for the studies assigned and that the workload of direct reports is adequate. This role will also:

  • Contributes to efficient SMM organization and its functioning at country level.
  • Oversight of feasibility and patient recruitment strategy for studies under supervision
  • Oversees successful delivery of SMM study delivery country level targets to plan, with speed and quality.
  • Contributes to the quality improvement of the study processes and other procedures.
  • Ensures completeness and timeliness of the eTMF to maintain it “Inspection Ready”.
  • Assists teams in forecasting study timelines, resources, recruitment, study materials and drugs.
  • Supports SMM region/global in initiatives/activities.
  • Reviews SQV reports of direct reports in line with AZ SOPs
  • Reviews Accompanied site visits/co- monitoring visits/training visits/QC visits performed to direct reports in line with the local QC plans.
  • Performs accompanied site visits according to local QC Plan, supporting ongoing coaching and development

Crucial Skills/Experience:

  • Master degree or equivalent qualification in relevant scientific discipline
  • Minimum of 10 years of proven experience in Development Operations or related fields within a pharmaceutical or clinical background
  • Strong Operations and/or field experience in clinical drug development
  • Good knowledge and experience in therapeutic area under supervision
  • Thorough knowledge of clinical study processes and local regulations
  • Excellent communication and relationship building 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.

Desirable Skills/Experience:

  • Advanced degree in a scientific discipline
  • Expert reputation within the business and industry
  • Extensive knowledge of the latest technical and regulatory expectations
  • Good knowledge of country investigators and site landscape
  • Medical knowledge in therapeutic area under supervision is a plus

At AstraZeneca, we follow the science and pioneer new frontiers. Join the team dedicated to Oncology, with an ambition to eliminate cancer as a cause of death. It's our big vision that unites and inspires us. With multiple indications and high-quality molecules at all stages of our innovative pipeline, we keep pushing forward. Fusing cutting-edge science with the latest technology to achieve breakthroughs. Backed by investment, we are aiming to deliver 6 new molecular entities by 2025.

A place built on courage, curiosity and collaboration. We make bold decisions driven by patient outcomes. Empowered to lead at every level, free to ask questions and take thoughtful risks that write the next chapter for our pipeline and Oncology team.

Pioneers of collaborative research we have built an unrivalled scientific community both internally and externally. Fusing academia and industry, we have united some of the world's foremost medical centres. Working seamlessly and inclusively, together we expedite research in some of the hardest-to-treat cancers.

Have the opportunity to build an exciting and meaningful career as part of the team committed to improving the lives of millions with cancer.

Be a part of our mission to eliminate cancer as a cause of death! Apply now and join us in our journey!

The annual base salary (or hourly rate of compensation) for this position ranges from $197,927.20 - 269,900.72. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.  In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles) or to receive a retirement contribution (hourly roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. 

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.

10000930 G CDSM

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Glassdoor logo Rated four stars on Glassdoor

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