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Director Study Management - BioPharmaceuticals

Location Warsaw, Mazovia, Poland Toronto, Ontario, Canada Job ID R-153300 Date posted 23/11/2022

At AstraZeneca, we are guided in our work by a strong set of values, and we’re resetting expectations of what a bio-pharmaceutical company can be. By truly following the science, we pioneer new methods, new thinking and bring unexpected teams together. From scientists to sales, lab techs to legal, we’re on a mission to turn ideas into life-changing medicines that transform lives. We need great people who share our passion for science and have the drive and determination to meet the unmet needs of patients around the world. If you’re swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.

The Director Study Management is responsible for leading, developing and providing direction to Study Management Late-stage Development Operations personnel to enable delivery of drug projects and non-drug projects. The role holder ensures that individuals/skill groups are equipped with the right skills, core & leadership capabilities to lead & deliver clinical studies.

Working in collaboration locally and globally (both within project and function) to support delivery of clinical programs in the Development Operations, BioPharmaceuticals R&D area of responsibility.

The Director Study Management takes responsibility and acts as change agent for building and developing the Study Management Late-stage Development organisation, processes and technology related to delivery of clinical studies or other core activities in Development Operations, BioPharmaceuticals R&D.

The role holder is also responsible for building a sustainable capability development framework to ensure Study Management Late-stage Development has the right capabilities to deliver future clinical studies.

Typical Accountabilities

Line management of Global Study Managers and Global Study Associates in Study Management Late-stage Development:

  • Recruit & retain & develop talents;
  • Encourage/reward staff practice of AZ values;
  • Ensure appropriate training, learning and development is provided to Hub personnel;
  • Coach staff for optimum performance;
  • Develop &  nurture future AZ leaders by leading and driving the capability development of the function;
  • Develop individual and Manage performance;
  • Provide expertise and direction to support direct reports with proactive problem/risk identification, solution building and issues resolution to facilitate achievement of objectives on time and to appropriate quality.

Delivery of projects:

  • Provide appropriately skilled Study Management Late-stage Development Operations personnel to study delivery teams to ensure delivery of clinical studies to time, budget and quality through an integrated skill set model in accordance with clinical performance targets;
  • Ensure staff understand global project priorities and specific project challenges;
  • Support staff/team to achieve project milestones and study deliverables;
  • Participate in decisions for allocation of staff to projects (globally cross-R&D organisations and/or within R&D organisations);
  • Work across departments with the other Development Operations leadership teams/ line managers (SMM country heads, Regional CPrMs, DMADs, etc.) either to support/ facilitate/ develop the framework for the project delivery or organizational/ Development Operations integrity/ Development.

Study Management Late-stage Development Leadership:

  • Sets & implements the vision & strategy for the individual Study Management Late-stage Development organisation, aligned with Development Operations, BioPharmaceuticals R&D vision and strategy;
  • Lead and support change by encouraging diversity of solutions that are value demonstrated;
  • Act as a change agent, with local and global impact, to ensure adoption of global initiatives;
  • Promote and encourage innovation and creativity by bringing suggestions/good examples to Study Management late-stage Development leadership;
  • Work with Directors within Study Management Late-stage development to support capacity management, achieving accurate resource forecasting, analysis and solution building to efficiently and flexibly resource study teams;
  • Ensure quality and compliance to external regulations and AZ standards, within and across global R&D organisations;
  • Work across the R&D organisations to develop global efficient ways of working;
  • Provide expert input into functional and cross-functional global processes;
  • Act in accordance with SHE delegation;
  • Leads dynamic sharing of Study Delivery knowledge, information, and best practice;
  • Networks with colleagues and experts.

Education, Qualifications, Skills and Experience

Essential:

  • Bachelor’s of Science in an appropriate discipline;
  • Extensive experience in Drug Development within a pharmaceutical or clinical background;
  • Thorough knowledge of Study Management processes and local regulations;
  • Excellent communication and relationship building skills.

Desirable:

  • Advanced degree in a scientific discipline;
  • Expert reputation within the business and industry;
  • Line Management experience.

Next step - Apply today!

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified 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. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.

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.

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