Global Clinical Operations Program Director at AstraZeneca in Gaithersburg, Maryland

Job Description:

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:



• 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).


• 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 mandatory


The annual base pay for this position ranges from $185,249.60 - $277,874.40 . Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. 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), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales 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 pay (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.