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Global Clinical Program Lead, Hematology

AstraZeneca
Full-time
Remote friendly (Gaithersburg, MD)
United States
Clinical Research and Development

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Role Summary

Global Clinical Program Lead (Hematology) responsible for leading the clinical development and execution of the product strategy for multiple hematology/oncology projects, reporting to the Global Clinical Head. Articulates project goals, strategy, and underlying science to internal and external audiences, and leads integrated plans across functions.

Responsibilities

  • Leads clinical development teams responsible for Hematology Oncology therapies from preclinical candidate selection through proof of concept to Phase 3 investment decisions; leads all regulatory submissions; accountable for clinical strategy and execution of a portfolio of pre-clinical and clinical stage therapies.
  • Accountable for delivery of projects according to quality, time, budgets, and resources.
  • Builds strategic and coordinated clinical development plans aligned with business objectives and differentiated from competitors.
  • Executes the integrated product plan to agreed scope, timelines, and budgets.
  • Leads and communicates the clinical development strategy at governance meetings; aligns with internal management and external collaborators.
  • Leads clinical aspects from preclinical Lead Optimization Investment Decision to clinical Proof of Concept (PoC); responsible for translational, clinical development, patient selection, regulatory, pediatric, and Asian development strategy.
  • Develops Target Product Profile aligning with disease area strategy and late-stage development.
  • Co-leads Clinical Program Team (CPT) to run/mitigate/communicate risk, make decisions, and handle change.
  • Maintains high CPT effectiveness through collaboration, influence, coaching, and mentoring of cross-functional team members.
  • Ensures robust processes, plans, and data to enable Governance Bodies to make investment decisions and prioritize projects across the portfolio.

Qualifications

  • M.D. required
  • Minimum of 7 years of relevant experience
  • Industry experience in drug development including early and late phase development and regulatory knowledge
  • Strong knowledge of Hematology Oncology with experience in diverse mechanisms
  • Broad understanding of the evolving clinical landscape in hematology/oncology
  • Ability to lead overall development of project strategy and manage plans, timelines, progress, and outcomes
  • Proven experience mentoring and motivating teams in a matrixed environment
  • Proven track record of cross-functional collaboration
  • Demonstrated organizational and project management skills
  • Proven ability to influence colleagues and senior leaders
  • High integrity