Senior Director, CMC Project Leader - Oncology
Do you have a passion for Science? Would you like to apply your expertise to impact a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!
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.
About the role
The CMC Leader is a key leadership position within Pharmaceutical Technology & Development, (PT&D.) You are accountable for strategy & planning, delivery and budget management of the CMC contribution to a small portfolio of projects in development as well as in market products. The role is critical to the successful development of AstraZeneca’s products and requires significant leadership and eye for business capabilities. You are a key member of the Global Project Team, GPT and Global Supply Teams, working collaboratively in a cross-functional and international environment to influence the development of AZ’s development and commercial drug portfolio.
You are accountable for the strategy and delivery of the Pharmaceutical Technology & Development contribution to projects in the early phase for the relevant iMed projects (after transition from Pharm Science, no later than ph IIb) as well as being accountable for projects managed by the GMeds. For in-market products, the role holder is accountable for the CMC activities associated with improving Brand Value. This may include owning the CMC related activities associated with LCM (new Clinical studies, filing in new markets, new formulations or devices), business development (divestments, partnering, in-licensing), supply chain re-engineering and CoG reduction, interpretation and application of new Regulations (Pharmacopoeia standards, country specific regulations).This is mainly within one TA but could also be across different Tas. You are accountable for phase III clinical supply design.
Project leadership, People Management, Problem Solving, Communication
Has overall accountability for defining and delivering the pharmaceutical development strategy that delivers effective development, approval, commercialisation and LCM of new medicines.
The key CMC accountabilities include
The overall development and technical strategy
The regulatory strategy and documentation for marketing authorisations (incl IND/IMPD)
For in-market products, the role holder is accountable for the development and delivery of the Post-Approval Manufacturability Strategy & Improvement Plan (PAMSIP).
Clinical supply chain strategy and plan for phase III (transferred generally at start of ph III)
Other Key Accountabilities include
Accountable to the GPT for maintaining and delivering all aspects of the pharmaceutical development plan including control of the scope, timing, resources, cost, quality and risk.
An active member of the GPT, contributing to the development of overall project strategies. Is encouraged to have credibility and influence within the team in which the role holder is a member.
Prior to transition of project leadership from iMed projects, work collaboratively with the Pharmaceutical Science project team to provide mentorship and line of sight. Timing of input will be dependent on project status and will be agreed between Pharmaceutical Science and PT&D.
Accountable for the technical development strategy for API, DP & Analytical aligned with project strategy and priority.
The role involves a diverse range of problems/opportunities requiring sophisticated judgements and solutions based on highly developed levels of conceptual thought and strategic vision and analysis.
Represents the Pharmaceutical Team on the GPT. Accountable for representing PT&D at key governance bodies including SET, LSPC, StAR and SC. The Pharmaceutical Lead is encouraged to be able to consistently demonstrate influence with partners in these fora in a way that builds value for AZ.
Will represent PT&D on the evaluation of business development opportunities
Has the responsibility to ensure that project strategies are reviewed according to the agreed processes in PT&D
Education and Experience, Functional & Business knowledge
Global drug development and clinical/commercial supply chain experience with business enterprise attitude and ideally good knowledge of the broader business especially development, commercialization, post-launch technical support and lifecycle management
Scientific degree or equivalent experience (or equivalent) and a good solid understanding of a CMC organisation.
A good solid understanding of project leadership approaches within the pharmaceutical industry and experience from working with projects from phase II through commercialisation and LCM. Preferably will have experience from functions outside PT&D.
Understanding of at least one AZ disease area.
Ability to identify and progress innovative ways and constructively challenging the status quo to achieve the best outcome for the project/brand and AZ
Good understanding of Regulatory requirements, the evolving landscape and the constraints/opportunities this presents
Experience of cost management and large scale projects
Skills and Capabilities
Demonstrated strong leadership with enterprise attitude, learning agility, networking and negotiation skills and collaborative approach and encouraginging of delivery of business objectives
Demonstrated strong interpersonal and communication skills (credible and persuasive) with ability to set clear direction and objectives for the team and to influence at a senior level in the organisation including Governance groups (GPT/ESPC/LSPC/TALT/Supply Committee and beyond)
Capable of managing the responsibilities for a diverse range of activities and projects acting as the key sponsor for projects and programmes supporting their project/product portfolio.
Excellent negotiation and influencing skills in order to influence and contribute to the cross-functional (iPT/GPT/EBT) project/product strategies and deliverables
Ability to develop & implement end-to-end Pharmaceutical strategy across all CMC areas (API, DP, etc.) aligned with the overall GPT strategy and clinical/commercial supply
Significant experience of leading multi-disciplinary teams with an ability to ensure accurate structure and team composition for efficient delivery and transition across the value stream
Leadership Capabilities Required:
Passion for Customers: Understands one’s customers and uses that insight to provide value
Thinks Strategically: Quickly identifies and acts on opportunities, combining forethought with action. This is based on an understanding of the external environment and its impact on AZ.
Acts Decisively: Makes and acts on decisions quickly and effectively and fosters the same in others. This is based on an underlying courage to enable risk taking for the business.
Drives Performance: Holds self and others accountable for the achievement of performance expectations. Creates an environment that enables others to perform at their best
Works Collaboratively: Actively creates and promotes cross boundary collaboration with the aim of archive better business results. Boundaries can exist between individuals, geographies, cultures, teams, functions or organisations.
Develops People and Organisation: Demonstrates and genuine commitment to the time and effort needed to develop oneself and others.
Working on a strong pipeline means so much more than producing innovative, ground-breaking medicines. It allows us to be part of long-term development programs with the variety that comes from working at the groundbreaking of science and technology. We explore innovations and confront challenges that others won't, to have a greater impact on patients' lives. We're proud of our pipeline – it’s not only changing the face of our industry for good and impacting the lives of patients, it’s transforming the careers of our people. We’re committed to a culture of continuous learning and people development so everyone at AstraZeneca can grow and thrive.
Competitive salary & benefits Offered
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.