Associate Director Clinical Development - Late CVRM

Are you passionate about science and have an extensive knowledge within the pharmaceutical industry? Are you also experienced within clinical operations and project management? At AstraZeneca, we work at the cutting edge of science to develop the ground-breaking medicines of the future - here we do things that have never been done before. Does this match your skills and ambitions for the future? Then join us to discover future treatments of Cardiovascular, Renal and Metabolic diseases!

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality, by doing the right things. We truly understand science and use our unique scientific capabilities to deliver what we believe to be one of the most productive pipelines in the industry. If you want to be part of a team that makes a bigger impact on patients' lives, then there's no better place to be.

We are now recruiting an Associate Director of Clinical Development (ADCD) to the Clinical Operations function of Late Stage Development Cardiovascular, Renal and Metabolic therapy area in BioPharmaceuticals R&D.



What you'll do

The role as an Associate Director Clinical Development is global, the span of responsibilities is broad and may support one or several products depending on their size and complexity. The products supported will be in Phase 3 development or already on the Market, but the program may include studies in all phases of drug development.

The ADCD is responsible for oversight of a program of global studies, covering all clinical development deliverables (including aspects of quality, budget, time, resource and risk). The role also involves integrating design, feasibility and operational planning to ensure clinical drug development programs are aligned with priorities and strategy. The ADCD will provide input and support to the Director of Clinical Development (DCD) in preparation for governance interactions. The ADCD may act as the lead for cross-functional teams in delivery of clinical activities assigned.

Additionally, the ADCD may provide project leadership and management for cross-functional clinical submission teams in support of regulatory marketing applications and post registration product maintenance phases. The ADCD may manage improvement or change projects within clinical operations or spanning multiple business areas.

This role can be based at AstraZeneca's dynamic R&D sites in Gothenburg (Sweden) or Gaithersburg (US).



Main Duties and Responsibilities

As a ADCD, you will be leading cross functional teams of experts in the planning and delivery of a defined clinical program of studies and/or clinical activities to scope, quality, budget, time; managing resource and risk on behalf of Director Clinical Development (DCD).

You will be an early adopter for new ways of working and act as ambassadors for change when leading teams.

The role includes leadership and program management of non-drug project work as assigned as well, eg cross functional improvement initiatives will also be a part of your role and you will contribute to functional and cross-functional initiatives as Subject Matter Experts.

In the role as ADCD you are expected to be able to work independently and be comfortable to prioritize the work for yourself and your team to meet business objectives. You will also mentor and support people development as appropriate.



Essential for the role:

* University degree, preferably in medical or biological sciences or discipline associated with clinical research (Advanced degree is preferred)
* Strong experience from within the pharmaceutical industry or similar large multinational organization
* Proven knowledge of clinical operations, project management tools and processes
* Previous experience of clinical development / drug development process in various phases of development and therapy areas
* Experience from leading clinical projects and deliverables or similar expertise from other areas of drug development (such as pharmaceutical development).
* Ability to mentor, develop and educate staff
* Proven leadership promoting motivation and empowerment of others in order to accomplish individual, team and organizational objectives
* Skilled & experienced in change management
* Ability to look for and champion more efficient and effective methods/processes of delivering Clinical Development focusing on key performance metrics around reliability, productivity, cost and quality
* Excellent written and verbal communication skills, negotiation, collaboration and interpersonal skills with ability to work effectively with others at all levels of the organization
* Demonstrated ability to set and manage priorities, resources, performance targets and project initiatives in a regional and local environment
* Integrity and high ethical standards



Desirable for the role:

* Project management certification is desirable but not mandatory
* Knowledge of process improvement methodology such as Lean Sigma/Change Management is desirable but not mandatory
* Regulatory submission experience



So, what's next?

We welcome your application, no later than February 28th 2021.

We will review the applications continuously, so please apply as soon as possible!