Global Program Team Lead

hace 2 semanas

Barcelona, Barcelona, España Barrington James A tiempo completo
Barcelona

  • JOB TYPE
  • Permanent
  • EMP TYPE
  • Full-Time
  • FUNCTIONAL EXPERTISE
  • Business Services, Clinical Development
  • SALARY TYPE
  • Annually
  • SALARY
  • Negotiable

GPTL Job Description


GPTL is responsible for providing strategic direction and leading the global drug development for 1 Global Program Team with a simple Phase III clinical development program or more than 1 Global Program Teams with clinical development programs in Phase I / II.

Typically, a GPT Lead would conduct their GPT work as part of a GMT and under the supervision of a GMT Lead (except for medicines with only one indication).


As the accountable program(s) owner/CEO, the Global Program Team Leader (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.

Hybrid role in Barcelona for a large global pharma company.

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 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 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

You will need to have:

  • Advanced lifescience degree (MD, PhD or PharmD)


Nephrology Experience - Clinical, Research or Clinical Development Ten 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 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 would prefer for you to have:

  • Nephrology development, clinical experience
LI-OG1

LI-Hybrid

Consultant

  • Oliver Gache

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