Introduction to role

The CMC Leader is a pivotal leadership position within Pharmaceutical Technology & Development (PT&D). You will be responsible 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. This role plays a vital role in the successful development of AstraZeneca's products and requires strong leadership and business insight. As a key member of the Global Project Team (GPT) and Global Supply Teams, you will work collaboratively in a cross-functional and international environment to influence the development of AstraZeneca’s drug portfolio.

Accountabilities

You will be accountable for the strategy and delivery of the Pharmaceutical Technology & Development contribution to projects in the early phase for relevant iMed projects (after transition from Pharm Science, no later than phase IIb) as well as for projects managed by the GMeds. For in-market products, you will be responsible 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.

What you'll do:

• Project leadership, People Management, Problem Solving, Communication

• Define and deliver the pharmaceutical development strategy that ensures 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, 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 phase III)

Other Key Accountabilities include:

• Accountable to the GPT for maintaining and delivering all aspects of the pharmaceutical development plan including control of scope, timing, resources, cost, quality, and risk.

• Active member of the GPT, contributing to the development of overall project strategies.

• Work collaboratively with the Pharmaceutical Science project team to provide mentorship and line of sight prior to transition of project leadership from iMed projects.

• Accountable for the technical development strategy for API, DP & Analytical aligned with project strategy and priority.

• Represent the Pharmaceutical Team on the GPT and at key governance bodies including SET, LSPC, StAR, and SC.

• Represent PT&D on the evaluation of business development opportunities.

• Ensure that project strategies are reviewed according to agreed processes in PT&D.

Essential Skills/Experience

• Global drug development and clinical/commercial supply chain experience with business enterprise attitude and ideally good knowledge of the broader business especially development, commercialisation, post-launch technical support and lifecycle management

• Scientific degree or equivalent experience and experience working within a CMC organisation.

• Working knowledge 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

• Business Programme/Project Management experience in global project teams and delivering change

• Good understanding of Regulatory requirements, the evolving landscape and the constraints/opportunities this presents

• Experience of cost management and large scale projects

• Experience in integrating digital learning/innovation into a work environment, with a focus on improving customer value and demonstrating strong business insight.

Skills and Capabilities

• Demonstrated strong leadership with enterprise attitude, learning agility, networking and negotiation skills and collaborative approach and encouragingly 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 cultivates 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 genuine commitment to the time and effort needed to develop oneself and others.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

AstraZeneca offers an environment where you can make a positive impact on society through our sustainability goals. Commit to making a difference beyond patients by pioneering AstraZeneca's sustainability strategy. You will have the opportunity to be a key contributor to Zero Carbon by 2025 and carbon negative across the entire value chain by 2030. Everyone can contribute towards our collective legacy of doing good for people, the environment, and society.

Ready to make a difference? Apply now!

Date Posted

26-Nov-2024

Closing Date

08-Dec-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.