You will be responsible for:

Program ownership with final accountability for clear definitions of program goals, plans, decisions and deliverables to meet those goals

Provides strategic direction and leadership of global development programs from Post-PoC to BLA/NDA/MAA for assigned projects in accordance with the global R&D strategy. Provides global development strategy and leadership for assigned projects to ensure clear goal setting and robust development plans for effective and efficient development. (This will entail working closely with core team members, functional leads, and other colleagues to collaborate and ensure their buy-in and knowledge-sharing in establishing and implement the global development strategy for assigned projects.)Ensures that the GPT implements its plans and adheres to key development milestones for assigned projects.Accountable for aspects of pre-clinical, CMC, clinical plans and programs across from Post-PoC through commercial approval for assigned projects.Leads the global project team and reviews development plans for assigned projects and thorough product lifecycle management for assigned projects.Contributes to objective setting and appraisal of core team members for program related activitiesKeeps senior management informedIs accountable for the program budgetEnsures high performance team effectiveness

You will need to have:

Advanced life-science degree (MD, PhD or PharmD)Oncology Experience Ten (10) + years of experience in drug development in pharmaceuticals, biopharmaceuticals, or biotechnologyLeadership experience including line/project management, multidisciplinary program management experience, which includes leadership in more than one IND/IMPS, BLA/NDA/MAA, Advisory Committee or other PMDA/EMA/FDA meetingsExperience leading drug development projects and activities in a matrixed, global organization.A broad experience communicating and working well with team members and relevant people as well as scientists and external decision-makers worldwide.A thorough understanding of how to influence local and global regulatory, scientific and commercial environments.Experience leading preparation of PMDA/EMA/FDA milestone meetings, such as Pre-IND, EoP-1, EoP-2, Pre-BLA/NDA, Advisory Committees, focusing on the key strategic issues.The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

We prefer you to have:

Oncology, clinical experience

Date Posted

23-abr-2025

Closing Date

16-jun-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 accommodations@Alexion.com. Alexion participates in E-Verify.