Senior Clinical Program Director, Early Clinical Development (R&I)

Do you want to make a difference for millions of patients by applying your expertise in a global company that follows the science and turn ideas into life changing medicines? At AstraZeneca, science is at the core of everything we do. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality.

The Senior Clinical Program Director (Senior CPD) is accountable for the overall delivery of the clinical program to time, cost, and quality and is the leader of the Clinical Program Team (CPT). The Senior CPD will collaborate to ensure that the clinical strategy and deliverables for the clinical program are delivered to the Early Global Product Team (eGPT). This role provides strategic oversight and feasibility input into the design of the clinical program and plays a key role in resolving possible program design options. The Senior CPD focuses on the program level, collaborating with Development Operations (Dev Ops), Clinical Project Team (CPT) members, eGPT colleagues, and all other functions key to the development of a compound.

The Senior CPD is expected to be a highly experienced drug developer with organizational understanding and influence. They will drive and guide the CPT and each of its functions, enhancing teamwork, productivity, and quality.

Accountabilities

• Accountable for leading the translation of science into streamlined and robust clinical development plans, including operational design options for assigned programs.• Accountable for leadership of the Clinical Program Team (CPT) and its oversight of clinical program strategy activities within each assigned program.• Accountable for providing strategic and operational input on clinical content to cross-functional program development plans.• Accountable for ensuring the development of the clinical program strategy, including pediatric and rare disease strategy, and China/Japan plans within the CPT, and for ensuring the implementation of innovative approaches to delivery with Development Operations.• Accountable for team leadership to provide clear direction and maintain a high-performing team.• Accountable for efficient and effective program management of all clinical development deliverables, including project strategy, design, and delivery of programs/studies to time, on budget, and within quality to deliver excellence in clinical program management.• Provide and ensure expert clinical input into various clinical documents including, but not limited to, Target Product Profile (TPP), Clinical Development Plan (CDP), Study Synopsis, IB, briefing documents, governance interaction material (e.g., CDID, Ph5>• Accountable for ensuring timely selection of an appropriate delivery model including selection of external providers for program/study-specific tasks.• Acts as a program-level liaison with external partners (e.g., CRO/ARO) and collaboration/alliance partners for program planning and delivery.• Accountable for development and management of contingency risk plans within each assigned clinical program to ensure operational delivery to quality, budget, and timelines, including management of program-level issue escalation and resolution.• Accountable for initial feasibility assessment and early country and site engagement to assist with formulating budget forecasts and trial timelines.• Ensure trial handover to assigned Global Study Lead (GSL) and study team. Post-study handover, carry out overall/strategic oversight to ensure that the study progresses according to E/SPC approved scope, cost, and timelines and to ensure a rapid response to emerging data (i.e., adapt the study/program as required based on emerging data).• Ensure quality practices in alignment with the highest ethical standards, GCP, ICH Guidelines, compliance with internal SOPs, local regulations, and laws.• Contribute to scientific interpretation of clinical data for discussion at governance meetings and external meetings, e.g., ad boards, conferences.• Coordinate and ensure KEE interactions and clinical advisory boards are accomplished to support clinical strategy and the development of the CDP.• Coordinate the clinical component of governance review (ESB, DRC, ESPC/LSPC) preparation.• Coordinate (if applicable through a MW) IB/clinical IMPD development. Provide input to DSUR.• Accountable for accurate budget forecasting, maintenance, and monitoring to baseline, clinical program resourcing, scenario planning, plus overall timelines for trials within assigned programs, including setup and maintenance within Company systems (e.g., PLANIT).• Contribute to driving best practices and support process-related improvements and workstreams, including alignment with digital health, clinical innovation, and ensuring timely compliance with Company governance controls.• Be early adopters for new ways of working and act as ambassadors for change.• Mentor and support people development within Early Clinical Development and DevOps Study Management.• Ensure alignment of the clinical strategy, transfer of program knowledge, and champion programs that are between early- and late-stage organizations.

Essential Skills/Experience

• Undergraduate degree in related field, preferably in medical or biological science. Advanced degree is preferred.• Extensive global drug development experience.• Leadership with ability to influence broadly within and outside the organization, motivate team members, and build cross-functional teams.• Consistent record to develop programs to meet business goals and assess business risk versus potential value; ability to understand global business requirements.• Experience in program management and use of project management techniques in complex projects, including resourcing and financial management.• Strategic influencing skills with ability to influence broadly within and outside the organization, empower team members, and build cross-functional teams.• Experience in clinical trial methodology with ability to deliver differentiated options based on sound knowledge of operational delivery.• Ability in problem-solving and issues management that are solution-focused.• Extensive experience in driving operational delivery to timelines, cost, and quality.• Validated experience in leading delivery through collaboration within globally matrixed teams, including internal organization and external providers.• Experience in selection and oversight of external providers and development/review of contracts.• Strong collaborative communication skills including ability to engage with diverse client base and lead through conflict.• Strategic skills including high level of creativity, innovation, problem-solving with ability to handle effectively through ambiguity.• Demonstrated ability to support and mentor junior or new team members.• A clear demonstration of behaviors: o Focus on patient centricity o Truth seeking rather than success seeking o Agile responsiveness to scientific data

When we put teams in the same room, we ignite 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 daring world.

At AstraZeneca, we are committed to making a difference by following science to explore new possibilities. We are dedicated to treating some of the world's most complex diseases by fusing data with scientific innovations. Our inclusive environment encourages collaboration across academia, biotechs, and industry experts. We harness digital tools like AI to fast-forward our research from lab discoveries to real-world impact. Our commitment drives us every day as we strive to improve patient access globally.

Ready to make an impact? Apply now!

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.