Global Development Global Clinical Program Lead, Hematology Oncology

AstraZeneca; España; Híbrido; EUR 150.000 - 195.000; Jornada completa

Descripción de la vacante

AstraZeneca is seeking a highly qualified Global Clinical Program Lead to lead the clinical development and execution of the product strategy across multiple hematology-oncology projects.

This role requires proven leadership, experience in hematology/oncology drug development, and the ability to align cross-functional teams, manage regulatory submissions, and communicate strategy at governance meetings.

Formación

• Hematology/oncology clinical drug development experience.
• Proven leadership and collaboration across multiple functions.
• Strong communication of project strategies to diverse audiences.

Responsabilidades

• Leads clinical development teams for novel Hematology Oncology therapies from preclinical through PoC.
• Leads all regulatory submissions.
• Accountable for clinical strategy and execution of a portfolio of therapies.
• Builds strategic and coordinated development plans aligned with business objectives.
• Executes the integrated product plan to scope, timelines and budgets.
• Leads and communicates the clinical development strategy at governance meetings.
• Leads clinical aspects from preclinical Lead Optimization Investment Decision to clinical PoC.
• Maintains CPT effectiveness through collaboration and influence.

Conocimientos

Hematology Oncology drug development

Leadership

Regulatory submissions

Cross-functional leadership

Descripción del empleo

Job Title: Global Development Global Clinical Program Lead, Hematology Oncology

Hybrid Working: In the office a minimum of 3 days per week

Location: This Global Clinical Program Lead role can be aligned to the following AZ locations: Barcelona, Boston, Gaithersburg, San Francisco, NYC

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world's most serious diseases. We are more than one of the world's leading pharmaceutical companies.

AstraZeneca has a multifaceted environment that cultivates collaboration and innovation. We attract top minds, and we nurture and build talent.

Within Hematology R&D, we are committed to advancing the science to deliver life-changing medicines to patients most in need. With a combination-focused pipeline that exploits the power of six scientific platforms (Immuno-Oncology, Tumor Drivers and Resistance, DNA Damage Response, Antibody-drug Conjugates, Cell Therapy and Epigenetics) to help address unmet clinical needs in a host of hematological cancers, we are motivated by a dedication to the scientific discovery and collaboration that will one day help eliminate cancer as a cause of death. This unit has responsibility for the value chain from discovery through to late-stage development, enabling rapid acceleration of promising early-stage assets and life-cycle management programs.

The Hematology Research and Early Development (R&D) team has the accountability for all drug development activities in hematology research 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, tolerability profile and therapeutic efficacy of our candidate drugs to support investment in late 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 disease indication. The individual will articulate the project goals, strategy and the underlying science and clinical need to internal and external audiences with clarity and credibility.

In 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 is created, and will demonstrate highly visible leadership within the oncology community, both within AZ and externally. 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.

Leads clinical development teams responsible for novel Hematology Oncology therapies from preclinical candidate selection through 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 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 ProgramTeam (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, coac