Global Clinical Program Lead, Hematology

About the role

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company focused on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. Within Hematology R&D, the unit is committed to advancing the science to deliver life-changing medicines to patients most in need, leveraging six scientific platforms (Immuno-Oncology, Tumor Drivers and Resistance, DNA Damage Response, Antibody-drug Conjugates, Cell Therapy and Epigenetics). The Hematology Research and Early Development (R&D) team has accountability for all drug development activities from first-in-human studies through late-stage trials leading to regulatory approval (Phase 1, 2 and 3).

This hybrid role requires a minimum of 3 days per week in the office.

Responsibilities

• Lead the clinical development and execution of the product strategy for multiple projects, accountable for the strategic clinical development plan and clinical execution of compounds.
• Articulate project goals, strategy and underlying science to internal and external audiences with clarity and credibility.
• Work with project leaders, scientific and clinical leaders, and external experts to coordinate integrated project plans delivered across functional boundaries.
• Ensure diverse views within the team are heard and empower a motivated team; demonstrate highly visible leadership within the oncology community both internally and externally.
• Lead clinical development teams responsible for novel hematology oncology therapies from preclinical candidate selection through proof of concept leading to Phase 3 investment decisions.
• Lead all regulatory submissions.
• Accountable for the clinical strategy and clinical execution of a portfolio of pre-clinical and clinical stage therapies.
• Accountable for delivery of projects according to quality, time, budgets and resources.
• Build strategic and coordinated clinical development plans aligned with business objectives and differentiated from competitor products.
• Accountable for execution of the integrated product plan to agreed scope, timelines, and budgets.
• Lead and communicate the clinical development strategy at governance meetings; align with internal management and communicate with external collaborators.
• Lead clinical aspects of projects from Preclinical Lead Optimization Investment Decision to clinical Proof of Concept (PoC), including translational, clinical development, patient selection, regulatory, pediatric, and Asian development strategy.
• Develop the Target Product Profile ensuring alignment with disease area strategy and late-stage development.
• Co-lead the Clinical Program Team (CPT) to effectively run/mitigate/communicate risk, make decisions, and handle conflict and change.
• Maintain a high degree of CPT effectiveness through collaboration, influence, and coaching/mentoring of cross-functional team members.
• Ensure robust processes, plans and data enable governance bodies to make investment decisions and prioritize projects across the portfolio.

Requirements

• M.D. required.
• Minimum of 7 years of relevant experience.
• Industry experience in drug development including early and late phase drug development and regulatory knowledge.
• 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.
• 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.