Senior Global Development Medical Director, Late - Barcelona, España - AstraZeneca

AstraZeneca

Empresa verificada

Barcelona, España

hace 2 semanas

Publicado por:

Isabel García

beBee Recruiter

Descripción

Job Description:

Senior Global Development Medical Director

About AstraZeneca:

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.

Oncology Research & Development, Late Clinical Development Oncology:
Our ambition is to eliminate cancer as a cause of death. It's our big vision that unites and inspires us. With multiple indications and high-quality molecules at all stages of our innovative pipeline, we keep pushing forward. Focusing on cutting-edge science with the latest technology to achieve breakthroughs. AZ is a place built on courage, curiosity and collaboration - we make bold decisions driven by patient outcomes.

Within Late Development Oncology, we push the boundaries of science to change the practice of medicine and transform the lives of patients living with cancer.

With one of the broadest and deepest Oncology pipelines in the industry, there are many opportunities to work with new and novel drugs and help discover what's next.

Supportive team players, we draw on diverse knowledge from across the business and external partners to come to bear on the toughest medical challenges.

What you'll do:

As
Global Development Medical Directors, we are diligent and committed to our science-driven and patient-centric approach, with a sharp focus on improving clinical outcomes.

The Global Development Medical Director is an important part of the Clinical Project Team (CPT), and Global Study Team (GST) working synergistically and cross functionally (in a matrix environment) with other CPT, GST and GPT members, Site Management & Monitoring (SMM), field-based liaisons, and site personnel.

The Global Development Medical Director and counterpart Global Development Scientist work collaboratively in the clinical aspects underpinning a product.

Accountabilities include clinical support for the development and implementation of late phase AstraZeneca sponsored clinical program strategies, including providing clinical input into design & implementation of clinical trial(s), their delivery, clinical data review, interpretation of results, reporting successfully on time, and activities required for worldwide registration of the product (i.e.

clinical input to (s)NDA/(s)BLA).

The Senior Global Development Medical Director plays a critical role in the medical monitoring of a clinical study ensuring safety to patients.

They share responsibility with Clinical Operations team members in the planning, execution and closure of a clinical study.

The Global Development Medical Director may also provide expert input or lead functional process improvement initiatives and provide contributions to cross-asset, cross-tumor working groups depending on the level of experience.

This position demands strong collaborative communication skills, including the ability to engage with and influence a diverse range of stakeholders both within and external to AstraZeneca.

The individual will operate according to the highest ethical standards in compliance with internal SOPs, local regulations, laws and adhere to Good Clinical Practice and regulatory requirements.

Depending upon experience level, the role will mentor the development of less experienced members of the clinical team, and may involve direct line management of other physicians or scientists.

Responsibilities include:

Responsible for the ensuring the riskbenefit of a clinical study, ensuring that all clinical studies operate to the highest ethical and safety standards and in compliance FDA, EMEA, ICH and GCP guidelines as well as AZ SOPs regarding safety
Work cross functionally within clinical product teams (CPT) to ensure the clinical strategy is translated into the development of the study concept document, study protocol and related documents
Significant contributor to the development of program strategy for assigned compound(s)/programs and work with GPT/CPT members to develop a compelling business case for governance approval
Provide expert clinical input to influence the study design via collaboration with primary investigators, key external experts (KEE), study sites, team members, and internal stakeholders, such that it reflects clinical practice, evolving landscape, regulatory and reimbursement requirements, and meets the strategic program objectives.
Participate or lead as needed the review and assessment of new opportunities and ESRs.
Accountable for the relevance and accuracy of clinical science underpinning of clinical study based on detailed scientific review and consultation, for the clinical and scientific leadership and integrity of protocols and/or components of clinical plans and for the delivery of final protocol and its governance approval.
Provides expert input into/lead the d