If you're inspired by the possibilities of science to change lives and you thrive when making brave decisions - join us. MedImmune
is the worldwide biologics research and development arm of AstraZeneca. Here, you'll have the opportunity to make a difference in people's lives every day. As one of the world's premier biotechnology companies, our mission is centered on delivering life-changing products that advance world health, and help fight and cure disease.
We're constantly pushing the boundaries of science to deliver life-changing medicines to patients, with a passion for discovery and a pipeline to show for it. We're pioneering innovative research and exploring novel pathways across key therapeutic areas including oncology, respiratory, inflammation and autoimmunity, cardiovascular and metabolic disease, and infection and vaccines. And we're industry-leading in immunology, protein engineering and translational science. We offer a unique and strong collaborative network as part of the AstraZeneca family, as together we explore synergies between small and large molecules.
MedImmune has a dynamic environment that fosters collaboration and innovation. We attract top minds, and we nurture and build top talent.
This position will be filled either in our Gaithersburg, MD or Cambridge, UK locations at the Director or Senior Director Level depending on level of experience.
The Director / Sr. Director, CVMD Clinical Operations will be responsible for overseeing delivery of the CVMD pipeline. This individual will be responsible for implementing the Clinical Operations CVMD strategy and ensuring delivery of the CVMD portfolio on time and within budget. This individual will manage a team of Clinical Operations Leads and Clinical Trial Managers to deliver this portfolio. He/She will be responsible for operational leadership of the CVMD portfolio, recruiting, retaining, motivating and developing talent. They will also need to effectively engage with physicians, internal and external stakeholders and external partners to facilitate advancement of the CVMD portfolio.
The Sr. Director Clinical Operations CVMD will be responsible for clinical operations leadership to deliver the CVMD goals and objectives on time and on budget. This will be achieved through management of appropriate staff as well as individual contribution to high priority projects.
This complex job role will manage multiple internal and external stakeholders. He/She is accountable for ensuring that all team members have clear focus on corporate objectives and deliverables. The position requires regular contact with persons of influence and decision-making authority within Clinical Biologics and overall R&D as well as other global and regional functions. The position requires considerable tact, discretion and persuasion to obtain desired outcomes while maintaining effective, positive organizational relationship.
Major Duties and Responsibilities:
- Implementation of the Clinical Operations CVMD strategy
- Responsible for several hundred million dollars of operational budget
- Recruit, mentor and manage a team of Clinical Operations Program Leaders and Clinical Project Managers dedicated to supporting the CVMD portfolio
- Manage resources/staffing assignments in a rapidly changing trial portfolio
- Ongoing capacity planning to project future resource needs and work with senior management to secure additional headcount
- Provide technical direction in CRO / ARO and vendor selection and management, budget planning and management in support of the CVMD portfolio
- Engage effectively with physicians, stakeholders, senior management and external partners in support of delivering the CVMD portfolio
- Serve as a member of Clinical Biologics Leadership Team and lead and participate in organizational process improvement initiatives and provide guidance on future direction of the organization.
Where required, for individual projects within TA, be responsible for providing expert clinical operational input into: iPDP, CDP, PCS, Clinical Study Protocol (CSP), and Clinical Study Report (CSR) and initial forecasting of Clinical Operations delivery related costs and timelines
- 10-15 years of global clinical operations experience
- A strong, motivational leadership style and ability to effectively manage senior stakeholders
- Experience in phase I through IV trials
- Extensive and proven experience in driving operational delivery to timelines, cost and quality
- Proven ability to deliver differentiated options based on a sound knowledge of operational delivery
- Proven experience leading delivery through collaboration with internal organization and external providers
- Thorough working knowledge of data management, data review and analysis, and safety surveillance and reporting
- Extensive experience at high level management/governance of CROs, AROs, central laboratories, and other clinical study vendors
- Proven ability in proactive problem solving and risk management that is solution focused
- Proven Global Project Management experience with expertise in program level resource and budget management
- Experience and strength in working and leading in matrix teams
- Experience in CVMD and renal is preferred
- University degree in related discipline, preferably in medical or biological science, or business/finance, or equivalent work experience in directly related fields of endeavors.
- Advanced degree is preferred. Certification or Degree in Project Management is a plus.
- Strong collaborative communication style and ability to engage with a diverse client base inclusive of high level conflict management capabilities
- Ability to motivate team members and build cross functional teams
- Capability to provide strong leadership and facilitation skills to link strategic direction to a clear operation plan
- Ability to manage effectively through ambiguity
- Ability to manage direct reports in multiple countries
- Willingness to travel both within the US and internationally
The appropriate candidate must:
- Act decisively
- Work collaboratively
- Exhibit passion for customers
- Drive performance
- Think strategically
- Develop people and organization
Possess a high level of creativity, innovation, and problem solving
Next Steps - Apply today!
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience - it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.
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.