Director, Early Global Program Team Lead

As the Director, Early Global Program Team Lead (EGPTL), you will be at the forefront of providing strategic direction and leading preclinical development for one or more programs and Early Global Program Teams (EGPT). You will drive the creation of an integrated development plan while maintaining strategic focus and ensuring commitments are met. Partnering with team members and collaborators, both within and outside R&D, you will stimulate creative discussion, motivate ownership, encourage urgency, and facilitate robust risk identification and mitigation. Representing the program to leadership and review committees, you will act as the liaison to other groups, ensuring clarity of purpose and responsibilities within the team.

Accountabilities

• Strategic direction and leadership of cross-functional early global program team(s) from candidate selection (CSID) through development investment decision (CDID) to IND acceptance in accordance with organizational goals.
• Program ownership with final accountability for strategy, goals, and deliverables.
• In partnership with the program manager and core team, develop and implement an efficient integrated plan and timeline for achieving program goals and achievements.
• Lead the program team in developing preclinical, clinical, regulatory, translational, biomarker, diagnostics, CMC, and clinical development plans through to approval to meet the target product profile.
• Identify potential risks to program objectives and timelines. Develop and implement mitigation strategies and ensure contingencies are in place.
• Build competitive intelligence to develop preclinical and clinical differentiation strategies supporting the reason for investment.
• Act as point of contact and project representative to governance, decision-making bodies, and senior leadership including information dissemination and the resolution of critical project issues.
• Ensure efficient writing and timely submission of the IND/CTA (and IDE if needed); coordinate and author sections of key regulatory documents as needed.
• Responsible for overall excellence, quality, and rigor, holding team members accountable for meeting high standards.
• Negotiate with and influence key internal and external collaborators to achieve program goals.
• In partnership with the program manager, develop the budget and maintain adherence to forecasts. Resolve resourcing issues, applying expertise to stay on schedule and on budget.
• Contribute to objective setting and appraisal of core team members for program-related activities.
• Create a motivated, committed, and engaged project team; ensure effective team behavior with clear roles and responsibilities.

Essential Skills/Experience

• Graduate degree in a life science field (MSc, PhD, MD/PhD, or PharmD).
• Experience in preclinical drug discovery and development in the pharmaceutical or biotechnology industries
• Experience leading preclinical drug development programs in a matrixed, global organization.
• Excellent critical thinking, problem-solving, and decision-making skills.
• Excellent communication and interpersonal skills, with the ability to influence others without direct authority, including team members, senior leaders, collaborators, and external decision-makers.
• Regulatory experience that includes a Pre-IND meeting, Scientific Advice meeting, or IND/CTA filing.
• A thorough understanding of the global scientific, regulatory, and commercial environments relevant to drug development.
• This is an office-based role with an expectation of a minimum of 4 days per week in office.

Desirable Skills/Experience

• Broad background and knowledge of rare disease.

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 four 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.

At AstraZeneca's Alexion division, we embrace an opportunity where work isn’t ordinary. Our closeness to patients brings us closer to our work and each other. With a rapidly expanding portfolio, you'll enjoy an entrepreneurial spirit and autonomy while meeting the needs of some of the most under-served patients in the world. Our culture celebrates diversity, innovation, and connection to patients' lived experiences. Here, your career is not just a path but a journey to making a difference where it truly counts.

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.