Global Development Scientist Director

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AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious diseases.

Any additional information you require for this job can be found in the below text Make sure to read thoroughly, then apply.

But we’re more than one of the world’s leading pharmaceutical companies.

Oncology Research & Development, Late Oncology Join a dedicated Oncology team that’s growing fast and building a strong track record of success.

We make bold moves at the cutting edge.

Transforming molecules to change the practice of medicine.

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

We are a science-based, leading and decisive Oncology enterprise united in our vision to eliminate cancer as a cause of death.

The pioneers, we make bold moves that transform the way cancer is treated and truly improve patient outcomes.

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.

What you’ll do The Medical Scientist is an important part of the Clinical Project Team (CPT), and Global Study Team (GST) working harmoniously and cross functionally (in a matrix environment) with other CPT & GST members, Site Management & Monitoring (SMM), field-based liaisons, and site personnel.

The Medical Scientist and counterpart Study Physician work collaboratively in the clinical aspects underpinning a clinical program.

This includes shared responsibility with Clinical Operations team members in the planning and execution, including recruitment and delivery of a clinical study.

Accountabilities include clinical support for the development and implementation of late phase AstraZeneca sponsored clinical program strategies.

As such, you will provide clinical/scientific 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 NDA/BLA).

In this role, you may also provide expert input or lead functional process improvement initiatives and provide contributions to cross asset or cross tumor area 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 (GCP) and regulatory requirements.

Other responsibilities include but are not limited to: Work cross functionally, accountable/responsible for scientific leadership and integrity (based on detailed scientific review and consultation) within CPT to ensure the clinical strategy is translated into the development of the study concept document, components of clinical plans, clinical study protocol and related documents.

Develop relationships with appropriate consultants and key external experts (KEE), study sites, and utilize these relationships to obtain feedback on protocol design, as well as study training, study execution, and interpretation of study results while contributing to advisory boards to ensure there is engagement with site specific KEEs.

Supports or leads interactions with global medical affairs, marketing companies, commercial, and regulatory functions in collaboration with GCH/GCPL to ensure cross functional input into protocols and contributes to technical review of protocols with governance bodies such as DRC and PRC.

Contributes to the development of Medical Oversight Plan (MOP), study level safety reviews and study-level medical monitoring activities and the development of content needed for governance committee interactions Essential for the role Bachelor’s degree with focus on life sciences or equivalent Industry or academic experience in drug development Detailed knowledge of Good Clinical Practice and other regulations governing clinical research.

General knowledge of 1) medical monitoring 2) Regulatory approval process in relevant countries; 3) pharmaceutical industry/R&D operations; 4) marketing and commercial fundamentals.

Ability to grow and maintain a high level of expertise in oncology therapeutic area.

Drug Development/Clinical Development Planning: Demonstrates the ability to undertake the planning, and timely organization of components of the clinical development plan Ability to drive/contribute to protocol design, writing and implementation Demonstrates solid understanding of methodology in the design, conduct, review and interpretation, and presentation of clinical research.

Desirable for the role Either Ph.D.

degree in life sciences or MD (preferred) Strong preference for Oncology experience Emerging leadership skills in individual and team settings to influence others and drive consensus building Emerging communication & presentation skills to communicate scientific concepts/data clearly and crisply in team settings and in formal presentations to leadership committees both internally and externally

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