Senior Director, Global Program Team Lead
Senior Director, Global Program Team Lead
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1 Vacancy
Job Description
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 PostPoC 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 buyin and knowledgesharing 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 preclinical CMC clinical plans and programs across from PostPoC 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 activities
- Keeps senior management informed
- Is accountable for the program budget
- Ensures high performance team effectiveness
You will need to have:
- Advanced lifescience degree (MD PhD or PharmD)
- Oncology Experience
- Ten (10) years of experience in drug development in pharmaceuticals biopharmaceuticals or biotechnology
- Leadership 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 meetings
- Experience 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 decisionmakers 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 PreIND EoP1 EoP2 PreBLA/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 officebased 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 nonlinear thought analysis and dialogue; collaborate with others; maintain general availability during standard business hours.
We prefer you to have:
- Oncology clinical experience
Date Posted
23abr2025Closing Date
16jun2025Alexion 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 EVerify.Required Experience:
Exec
Employment Type
Full-Time
