Global Clinical Operations Program Director

GLOBAL CLINICAL OPERATIONS PROGRAM DIRECTOR (GPD)

Are you passionate about science and have an extensive knowledge within the pharmaceutical industry? Are you also experienced within Clinical Operations and project management?
We are now recruiting a Global Clinical Operations Program Director (GPD) to the BioPharmaceuticals Clinical Operations function for Late Stage Development Cardiovascular, Renal and Metabolic therapy area in R&D to support our vibrant portfolio.
This role will be based at AstraZeneca’s dynamic R&D site in Gaithersburg (US).

WHAT YOU’LL DO

The role as a GPD requires global collaboration and leadership. 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 commercially available, but the program may include studies in all phases of drug development.
The GPD 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 GPD will provide input and support to the Senior GPD in preparation for governance interactions. The GPD may act as the lead for cross-functional teams in delivery of clinical activities assigned.

MAIN DUTIES AND RESPONSIBILITIES

As a GPD, 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 the Senior GPD.
The GPD may manage improvement or change projects within Clinical Operations or spanning multiple business areas. 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 project management of non-drug project work, e.g. functional and cross functional improvement initiatives and you will also contribute to initiatives as Subject Matter Expert.
In the role as GPD 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:

• Bachelor’s 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).
• Regulatory submission experience
• 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 in English
• Excellent 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 mandator