Director, Early Global Program Team Leader
Director, Early Global Program Team Leader
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1 Vacancy
Job Description
Are you ready to lead the charge in preclinical development As the Director Early Global Program Team Lead (EGPTL) you will be pivotal in steering strategic direction and guiding preclinical development for one or more programs and Early Global Program Teams (EGPT). Your role will involve crafting an integrated development plan maintaining strategic focus and ensuring commitments are met. Collaborate with team members and external partners to fuel creative discussions foster ownership instill urgency and facilitate robust risk identification and mitigation! Represent your program to leadership and review committees acting 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:
- MSc PhD MD/PhD or PharmD with a minimum of 8 years of experience.
- 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. Thats why we work on average a minimum of four days per week from the office. But that doesnt mean were 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 we are driven by a passion for innovation that transforms lives. Our commitment to rare disease biopharma places us at the forefront of biomedical science. With transparency objectivity and ethics as our guiding principles we push boundaries to translate complex biology into transformative medicines. Our global reach and potent capabilities allow us to shape the future of rare disease treatment into new areas of unmet need. Here you will find a vibrant culture that fosters connections encourages exploration of new ideas and supports learning. Empowered by tailored development programs designed for skill enhancement and empathetic understanding of patient journeys youll be part of a community dedicated to making a difference.
Ready to make an impact Apply now to join our team!
Date Posted
27-May-2025Closing Date
24-Jul-2025Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment training compensation promotion and other terms and conditions of employment based on race color religion creed or lack thereof sex sexual orientation age ancestry national origin ethnicity citizenship status marital status pregnancy (including childbirth breastfeeding or related medical conditions) parental status (including adoption or surrogacy) military status protected veteran status disability medical condition gender identity or expression genetic information mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation please contact Alexion participates in E-Verify.Required Experience:
Exec
Employment Type
Full-Time
