Global Pharmaceutical Project Director (Oncology/CMC) - Gaithersburg, MD - Global Operations
Are you looking to make a difference in the life of cancer patients? If so, this could be the role you are looking for!
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. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.
With innovation at the center of everything we do, Pharmaceutical Design & Technology designs and delivers the active drug product (including formulations, devices and packaging) required to support new medicines.
The Global Pharmaceutical Project Director in our Pharmaceutical Technology & Development (PT&D) organization as part of Global Operations, you will be based at our Gaithersburg, MD site. Our campus employs more than 3,500 specialists in our field and is only a short drive from Washington, DC. This modern scientific campus is the home of R&D and Oncology in the US. Here, we play host to some of the most cutting-edge technology and lab spaces, all crafted to encourage teamwork and cross-functional science. This is where you’ll find newly-designed, activity-based work spaces to suit a variety of working styles while growing teamwork between teams.
**The successful candidate will be hired at either an Associate Director or Director level based on skills and experience**
What you will do:
Single point of accountability for the projects in PT&D, you will responsible for the CMC project strategy and execution
Take ownership and drive the strategy and successful delivery of drug projects in mid- to late-stage development through the submission and launch process. For any in-market products, you'll be accountable for the activities associated with improving Brand Value.
Represent the Pharmaceutical Team on the Global Project Team.
With overall accountability for driving and defining the pharmaceutical development strategy, you will coordinate the delivery of the effective development, approval, commercialization and Life-Cycle Management (LCM) of new medicines.
Through being involved in a diverse range of problems and opportunities, you will use your experience to look after complex judgments and solutions. You'll need to call on your levels of conceptual thought and strategic vision and analysis in order to reach resolution.
Develop governance presentations and represent PT&D at key governance bodies. Consistently demonstrate your influence with business partners to build value for AZ.
PT&D ambassador across the enterprise.
B.S. in Science or Engineering required.
To be successful in this role, you have a minimum of eight (8) years (Associate Director) OR a minimum of 12 years (Director) hands-on experience in cross-functional drug development, possess a CMC background, strategic acumen, and demonstrated project Leadership/project management skills.
Business enterprise approach and good understanding of the broader business arena, including clinical development, commercial, global regulatory requirements (the evolving landscape and the constraints/opportunities this presents), NDA submission and approval, commercialization, post-launch technical leadership and LCM.
Ability to identify and progress innovative ways and constructively challenging the status quo to achieve the best outcomes for the project and AstraZeneca.
Experience of cost and resource management for large scale projects.
Strong communication skills to enable effective influencing of various stakeholders and team members
Advanced scientific degree
Oncology drug development experience
Small Molecules experience
At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, groundbreaking cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey!
Next Steps – Apply today!
Are you ready to bring new insights and fresh thinking to the table? We have one seat available, and we hope it's yours! Curious to know more, then 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. Know someone who would be an excellent fit? Please share this posting with them.
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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 authorisation and employment eligibility verification requirements.