Director, Clinical Supply Solutions
Location: Cheshire East, Gaithersburg, Maryland
Job Type: Full time
Director, Clinical Supply Solutions
At AstraZeneca, we 're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients, and society. An expansive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development.
Join the team where everyone feels a personal connection to the people that we impact. From our science labs to manufacturing at scale, we are committed to delivering at the highest quality. It’s inspiring and rewarding work, influencing every part of the product lifecycle to deliver life-changing medicines. To ultimately make people’s lives better – from patients and their families to all of us in society!
Across an R&D therapy area portfolio spanning hundreds of internally and externally sponsored clinical trials, this role will be accountable for the strategy and delivery of specific capability teams which provide services, study delivery and support to the broader clinical supply teams for Oncology and Biopharma.
The role is a global line leadership role within Clinical Manufacturing & Supply. Whilst reporting into the Biopharma Clinical Supply Executive Director, this function will be supplying both Therapy Areas. The role holder will develop, manage, and improve capabilities for the areas defined in scope of the role (Label content, IRT Set up, Clinical Associate Support) ensuring no delays to new study start up and no disruption to supply to patients throughout the life of a study.
You will play a pivotal leadership role in bridging the relationship and partnership with the IRT function and alliance management for IRT services within Biopharma ClinOps to drive aligned strategy, drive innovation, improve outcomes and deliver business results.
Line Management of globally based teams
Responsible for line management, coaching and development of team managers and direct reports.
Translating strategy and objectives into a meaningful direction for the group that every individual connects with and fosters a great place to work climate.
Provide leadership, coaching, mentorship, and direction to team members and drive a strong lean culture that promotes standardization, simplification, and continual improvement.
Global Orchestration and execution of IRT, Label Content and Clinical Study Associate Services
Accountable for developing regulatory compliant CTM labels, IRT and clinical associate services (on-time, in full, right quality to agreed cost) to agreed timelines to enable delivery of the portfolio and meeting clinical milestones.
Provision of expert support to ensure portfolio & project targets are met (specifically in label content, IRT & Clinical study associate services).
Portfolio and capacity management for group fully aligned with budgeting processes.
Input into financial budgeting processes and delivery of group to budget.
Delivery of year-on-year productivity tracking and improvements, linking with appropriate resource forecasting in PLANIT.
Accountable for leading the clinical supply input to BRM’s and for performance metrics for specified third party suppliers for Clinical Supply Solutions to ensure delivery of the AZ portfolio OT, IF, RQ, AC for clinical supply requirements.
Develop a strategy for the IRT in conjunction with ClinOps which grows capabilities and ensures aligned capacity to meet the future vision and business objectives (including digital interdependencies).
Develop a strategy for the label content provision which grows capabilities to meet the future vision and business objectives (including digital interdependencies).
To be an active member of the Oncology & Biopharma Clinical Supply Chain Leadership teams taking joint responsibility in developing the vision, strategy and objectives that deliver an optimal end to end clinical supply chain.
Business Process Management
Accountable for business process ownership of clinical label content creation and the associated systems (LRA / Prysm etc) for a range of business models (in-licenses, owned subsidiaries, partnership agreements).
Accountable for business process ownership of Supply chain aspects of IRT set up and maintenance that meets the future vision and business objectives for a range of business models (in-licenses, owned subsidiaries, partnership agreements).
Business partnering with Global Regulatory Affairs to ensure Label text and timelines support Submission targets and with DevQ to ensure aligned ways of working, resourcing and plans to meet the portfolio.
Business Partnering with Biopharma ClinOps IRT function and alliance management to influence and collaborate on IRT strategy and performance, developing shared goals across the functions.
Collaborative working across Biopharma and Oncology Clinical Supply chains study and programme facing roles across the portfolio, ensuring effective clinical supply chains.
Develop external links specifically supporting IRT, Labels and Clinical supply associates to develop AZ to be clinical supply best practice for these areas, bench-marking to understand positioning and opportunity.
Essential skills & experience:
Degree or equivalent experience
Leadership experience in a supply chain or clinical operations environment
Strong communication and stakeholder management skills
Evidence of leading in a matrix environment with exceptional stakeholder management
Ability to partner across diverse business areas
Proven ability to motivate, develop and empower others to accomplish outstanding individual, project and organisational goals
Clinical Supply experience
Technical knowledge of clinical supply systems and processes (e.g. IRT, label content provision)
Leadership of team in a global and matrix environment
Financial or budgeting experience
Lean training or certification
Awareness of external regulations related to clinical supply.
Experience of leading/managing in a GMP environment, preferably with experience of GXP systems
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.
So, what’s next
Are you interested in joining our team? Good, because we can’t wait to hear from you!
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 (e.g. race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status). 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.
AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.