Global Clinical Program Lead, Hematology
About The Position
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company dedicated to the discovery, development, and commercialization of prescription medicines for serious diseases. Within Hematology R&D, the team is committed to advancing science to deliver life-changing medicines for patients in need. 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 robust preclinical, clinical, and translational data packages to support investment in late-stage clinical development and drug approval. 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 report to the Global Clinical Head (GCH) of the disease indication and will be responsible for articulating project goals, strategy, and the underlying science and clinical need to both internal and external audiences. The GCPL will collaborate with other project leaders, scientific and clinical leaders, and external experts to coordinate integrated project plans across functional boundaries, ensuring diverse team views are heard and fostering an empowered and motivated team. Demonstrated leadership within the oncology community, both internally and externally, is expected, along with hematology/oncology clinical drug development experience and the ability to critically navigate the science underlying these programs. Effective communication across a broad range of audiences and the ability to articulate project-specific and overall oncology strategies are essential.
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 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 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.
- 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.
- Ensures 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
