Global Clinical Program Lead, Hematology R&D

AstraZeneca • Gaithersburg, MD

5d • Hybrid

About The Position

The Hematology Research and Early Development (R&D) team is responsible for all drug development activities in hematology research, from first-in-man studies to late-stage trials leading to regulatory approval (Phase 1, 2, and 3). The team aims to deliver strong preclinical, clinical, and translational data packages that build confidence in the dosing strategy, tolerability, and therapeutic efficacy of candidate drugs to support investment in late-stage clinical development and drug approval. We are seeking a highly qualified Global Clinical Program Lead (GCPL) to spearhead the clinical development and execution of product strategies for multiple projects. This role reports to the Global Clinical Head (GCH) of the disease indication and is accountable for the strategic clinical development plan and clinical execution of compounds. The GCPL will collaborate with other project leaders, scientific and clinical leaders, and external experts to coordinate integrated project plans across functional boundaries. This individual will foster an environment where diverse team perspectives are valued, leading to a motivated and empowered team, and will exhibit visible leadership within the oncology community, both internally and externally.

Requirements

• M.D. is required.
• A minimum of 7 years of relevant experience.
• Industry experience in drug development including experience in early and late phase drug development and regulatory knowledge.
• Hematology/oncology clinical drug development experience.
• Demonstrated leadership.
• Ability to critically navigate the science that underlies these programs.
• Ability to effectively communicate across a broad range of audiences.
• Ability to clearly articulate project specific strategies as well as the overall oncology strategy.
• Strong knowledge and understanding of the Hematology Oncology therapeutic area with experience in diverse biological mechanisms.
• Broad understanding of the evolving clinical landscape in hematology/oncology.
• Lead the overall development of project strategy and be accountable for project plans, timelines, progress, and outcomes.
• Proven experience mentoring and motivating teams in a highly matrixed environment.
• Proven record of encouraging and leading internal and external cross-functional collaborations.
• Demonstrated organizational and project management skills.
• Proven success in influencing colleagues and senior leaders in various departments.
• Must demonstrate high integrity.

Responsibilities

• Leads clinical development teams responsible for novel hematology/oncology therapies from preclinical candidate selection through proof of concept leading to Phase 3 investment decisions.
• Leads all regulatory submissions.
• Accountable for the clinical strategy and clinical execution of a portfolio of pre-clinical and clinical stage therapies.
• Accountable for the delivery of projects according to quality, time, budgets, and resources.
• Builds strategic and coordinated clinical development plans aligned with business objectives and differentiated from competitor products.
• Accountable for the execution of the integrated product plan to agreed scope, timelines, and budgets.
• Leads and communicates the clinical development strategy at governance meetings, accountable for aligning with internal management and for communicating with external collaborators.
• Leads clinical aspects of projects from preclinical Lead Optimization Investment Decision to clinical Proof of Concept (PoC).
• Responsible for all clinical aspects of project strategy including translational, clinical development, patient selection, regulatory, pediatric, and Asian development strategy.
• Develops the Target Product Profile, ensuring alignment with disease area strategy and late-stage development.
• Co-leads the Clinical Program Team (CPT) to effectively run/mitigate/communicate risk, make decisions, and handle conflict and change.
• Responsible for maintaining a high degree of CPT effectiveness through collaboration, influence, and, as necessary, coaching and mentoring of cross-functional team members.
• Ensures that there are robust processes, plans, and data to enable Governance Bodies to make investment decisions and prioritize projects across the portfolio.
• Primary clinical focus will be CLL and related lymphoid malignancies in both early and late-stage studies but may not entirely be limited to this area.

Benefits

• Qualified retirement program [401(k) plan]
• Paid vacation and holidays
• Paid leaves
• Health benefits including medical, prescription drug, dental, and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree