Global Clinical Program Lead, Hematology R&D

Title:

Global Clinical Program Lead, Hematology Oncology Hybrid working:
Minimum of 3 days per week in the office Locations:
Gaithersburg, Maryland;
Boston, Massachusetts;
South San Francisco, California or Manhattan, New York. Summary of Group:

The Hematology Research  and Early Development (R&D) team has the accountability for all drug development activities inhematologyresearch from first in man studies, all the way to late-stage trials leading to drug approval by regulatory agencies (Phase 1, 2 and 3 trials). The team strives to deliver compelling preclinical,clinical and translational data packages providing confidence in the dosing strategy, tolerabilityprofileand therapeutic efficacy of our candidate drugs to support investment inlate-stage clinical development, leading to drug approval.

We are looking for a highly qualified Global Clinical Program Lead (GCPL) candidate to lead the clinical development and execution of the product strategy for multiple projects. This individual will be accountable for the strategic clinical development plan and clinical execution of the compounds and reports to the Global Clinical Head (GCH) of the  this role the candidate will work with other project leaders, scientific and clinical leaders as well as external experts to coordinated integrated project plans which can be delivered across functional boundaries.

The candidate will ensure that diverse views within the team are heard and that a strongly empowered and motivated team iscreated andwilldemonstratehighly visible leadership within the oncology community, both within AZ and externally.

• Leads clinical development teams responsible for novel hematology/oncology therapies from preclinical candidateselectionthrough proof of concept leading to Phase 3 investment decisions. The candidate will lead 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 coordinatedclinicaldevelopment plans which are aligned with businessobjectivesand are differentiated from competitor products.

• Accountable for the execution of the integrated product plan to agreed scope, timelines, and budgets

• Leads and communicates theclinicaldevelopment 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 allclinicalaspects 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 andlate-stage development

• Co-leads the Clinical Program Team (CPT) to effectively run/mitigate/communicate risk, make decisions, and handle conflict and change.

• Responsible formaintaininga high degree ofCPT 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.

• 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.

• 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.

• The successful candidate will have hematology/oncology clinical drug development experience,demonstrated leadership, and be able to critically navigate the science that underlies these programs. The candidate should be able to effectively communicate across a broad range of audiences and have an ability to clearly articulate project specific strategies as well as the overall oncology strategy.

• Strong…