Global Clinical Program Lead, Hematology
About The Position
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company committed to discovering, developing, and commercializing prescription medicines for serious diseases. Within Hematology R&D, the team focuses on advancing science to deliver life-changing medicines for patients with hematological cancers. 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 compelling data packages to support investment in late-stage clinical development. This role is for a highly qualified Global Clinical Program Lead (GCPL) to lead the clinical development and execution of product strategy for multiple projects. The individual will be accountable for the strategic clinical development plan and clinical execution of compounds, reporting to the Global Clinical Head (GCH) of the disease indication. The role involves articulating project goals, strategy, science, and clinical need to internal and external audiences, and collaborating with project leaders, scientific and clinical leaders, and external experts to coordinate integrated project plans across functional boundaries. The candidate will foster an empowered and motivated team and demonstrate leadership within the oncology community. A strong background in hematology/oncology clinical drug development, demonstrated leadership, and the ability to critically navigate the underlying science are essential. Effective communication across diverse audiences and the ability to articulate project-specific and overall oncology strategies are key.
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.
- 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 project according to quality, time, budgets and resources.
- Build strategic and coordinated clinical development plans which are aligned with business objectives and are 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.
- Lead 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.
- Development of 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.
- Ensure that there are robust processes, plans and data to enable Governance Bodies to make investment decisions and prioritize projects across the portfolio.
Benefits
- short-term incentive bonus opportunity
- equity-based long-term incentive program (salaried roles)
- retirement contribution (hourly roles)
- commission payment eligibility (sales roles)
- qualified retirement program [401(k) plan]
- paid vacation and holidays
- paid leaves
- health benefits including medical, prescription drug, dental, and vision coverage
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
