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AstraZeneca · 6 hours ago

Senior Director, Global Program Team Lead

US - Boston - MA

Full-time

Hybrid

Director/Executive

10+ years exp

AstraZeneca is a leading biopharmaceutical company seeking a Senior Director, Global Program Team Lead. The role involves driving drug development programs, providing strategic direction, and leading global teams to ensure effective and efficient development of projects from Post-PoC to commercial approval.

BiopharmaBiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine

Comp. & Benefits

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

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

Stimulates creative and productive discussion, motivates, ownership and urgency as well as robust discussions of risk identification and mitigation opportunities

Ensures clarity of purpose and responsibilities with the GPT

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

Acts as the voice of the GPT up the line and is the principal liaison and partner to other groups

Qualification

Drug development experienceLeadership in clinical programsRegulatory knowledgeProject managementCross-functional leadershipAnalytical skillsCommunication skillsTeam collaboration

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

AstraZeneca

Glassdoor4.1

AstraZeneca is a pharmaceutical company that discovers, develops, manufactures, and markets prescription medicines. It is a sub-organization of Investor.

Founded in 1999

Cambridge, Cambridgeshire, GBR

10001+ employees