Clinical Program Director – Early Phase Clinical Operations CVRM

Are you passionate about science and have an extensive knowledge within clinical drug development? Are you also an experienced Leader that wants to combine your leadership skills with your strategical understanding of designing clinical programs? 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 your passion is science and 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 offering an exciting opportunity for a talented and highly motivated individual to join us in the role as Clinical Program Director within Early Phase Clinical Operations CVRM based at AstraZeneca’s dynamic R&D site in Gaithersburg (US). This is a global role in the organization and as Clinical Program Director you will be working in a diverse and cross-functional environment.

What you’ll do

In the role as Clinical Program Director in Early CVRM programs, you will be accountable for the delivery of the assigned clinical program(s) to time, cost and quality and be a core member of the Clinical Program Team (CPT). The Clinical Program Director may work in more complex projects supporting the Senior Clinical Program Director or may be assigned to lead the CPT of a less complex clinical program. 

You will work closely with the core CPT members to ensure that the clinical strategy and deliverables for the clinical program are delivered to the Early Global Product Team (eGPT). The role provides strategic oversight and feasibility input into the design of the clinical program and plays a key role in the work required to determine possible program design options. Your focus is across the program level, collaborating with the Early Clinical Development organization, Clinical Project Team (CPT) members, eGPT colleagues and all other functions that are key to the development of a compound.

Main Duties and Responsibilities

In the role as the Clinical Program Director you will be (as delegated from the Senior Clinical Program Director in more complex projects):

• Leading the Clinical Program Team (CPT) and its oversight of clinical program strategy activities and deliveries within assigned programs
• Providing efficient and effective program management of all CPT deliverables, including project strategy, design and delivery of CPT driven program/studies to time, on budget and with quality
• Providing strategic and operational input to cross-functional program development plans and be accountable for cross-functional leadership roles as delegated from the eGPT
• Ensuring initial feasibility assessment and early country and site engagement to optimize clinical program delivery
• Acting as the initial and program-level AZ interface with externally managed/outsourced partners (e.g. CRO/ARO) and collaboration/alliance partners for program planning and delivery
• Developing and managing of contingency risk plans within each assigned clinical program, including management of program issue escalation and resolution
• Proving an accurate budget forecasting, and maintenance, and monitoring to baseline, clinical program resourcing, scenario planning, plus overall timelines for trials within assigned program, including setup and maintenance within Company systems

Essential for the role

• Master/PhD of Science degree in natural sciences or medicine (advanced degree is preferred)
• At least 10 years global pharmaceutical drug development and leadership experience demonstrated in a variety of roles and at least 3 years experience from working in clinical funct