Alexion Pharmaceuticals, Inc. · 7 hours ago
Senior Director, Global Program Team Lead
Boston, Massachusetts, United States of America
Full-time
Hybrid
Director/Executive
10+ years expAlexion Pharmaceuticals, Inc. is focused on delivering innovative medicines for rare diseases. They are seeking a Senior Director, Global Program Team Lead to drive drug development programs and provide strategic direction for clinical development projects.
BiotechnologyHealth CareMedicalTherapeutics
Responsibilities
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
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 activities
Keeps senior management informed
Is accountable for the program budget
Ensures high performance team effectiveness
As the accountable program(s) owner/CEO, the Global Program Team Lead (GPTL), leads and chairs the Global Program Team (GPT), leading the creation of an integrated development plan, maintaining a strategic focus and ensuring the GPT’s commitments are met
The GPTLs role is one of leadership, being proactive and interactive, and emphasizing partnership with all GPT members and other stakeholders and consultants both within and outside R&D
The GPTL should stimulate creative and productive discussion, motivate, ownership and urgency (when necessary) as well as robust discussions of risk identification and mitigation opportunities, and ensure clarity of purpose and responsibilities with the GPT
The GPTL has negotiation and persuasion skills necessary to ensure success of the program and sets goals for the GPT and specific program-related goals for the Core Team members
GPTLs are the “voice” of the GPT up the line (GMT Leadership, R&D and VISion Leadership, Development and Commercial Steering Committee and Executive Committee), and the principal liaison and partner to other groups
Qualification
Required
Science or medical degree (e.g. MD, PhD, PharmD), with specialist training or significant experience in either Haematology or Nephrology
Total 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 is desirable
Minimum of ten (10) years of experience in drug development in pharmaceuticals, biopharmaceuticals, biotechnology or equivalent cross-functional leadership experience
Demonstrated experience leading the development of at least one development candidate with adherence to quality, excellence and efficiency
Demonstrated experience leading drug development projects and activities in a matrixed, global organization
A broad understanding of how to communicate and work 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
Ability to assimilate data, recognize key variables and analyze complex situations
Has 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
Excellent understanding of the interdependencies of the various disciplines (e.g., CMC, Pharm/Tox, PK, Clinical, Regulatory, Marketing, Finance) – what needs to be evaluated simultaneously vs. sequentially etc. from a strategic planning/risk management time/event/cost point locally and globally
Has a firm understanding of how to educate/advise/operate with respect to Regulatory Guidances/Internal SOPs/Project best-practice behaviours
Company
Alexion Pharmaceuticals, Inc.
Alexion, AstraZeneca Rare Disease is focused on pioneering new possibilities for the rare disease community.
1001-5000 employees
H1B Sponsorship
Alexion Pharmaceuticals, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (49)
2024 (57)
2023 (51)
2022 (29)
2021 (27)
2020 (17)
Funding
Current Stage
Public CompanyTotal Funding
$5.8M2020-12-12Acquired
1999-02-12Post Ipo Equity· $5.8M
1996-02-29IPO
Leadership Team
Frederic Chereau
SVP, Strategy and Business Development
Imran Shakur
Director, IRT and Technology Lead
Recent News
bloomberglaw.com
2025-12-20
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