Late Clinical Development, Global Development Scientist (R-139752_Gaithersburg)
Do you have expertise in, and passion for clinical drug development?
Are you looking to work at the cutting-edge, where scientific innovations and an entrepreneurial spirit are the norm?
Join the team at the heart of AstraZeneca dedicated to Oncology, committed to following the science.
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 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
Global Development Scientists, at all levels, are 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 Global Development Scientist and counterpart Global Medical Directors 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). 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 and 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 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.
• 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, interpretation of study results and inform recruitment strategies.
• Responsible for the relevance and accuracy of clinical science underpinning of clinical study based on detailed scientific review and consultation.
• Accountable for the clinical and scientific leadership and integrity of protocols, clinical study reports and/or components of clinical plans.
• 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.
• 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.
• Responsible for the clinical and scientific input into a study and for the quality of the clinical data
• Contribute to advisory boards to ensure there is engagement with site specific KEEs to ensure robust study designs, recruitment strategies.
• Contributes to the review and interpretation of clinical data (HLRs) and the development of
content needed for governance committee interactions seeking Go/No Go decisions.
Essential for the role
• Bachelor’s degree with focus on life sciences or equivalent
• Industry or academic experience in drug development
• Detailed knowledge of GCP 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 and work with other functions to achieve successful study initiation and execution.
• 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
• Ph.D. degree in life sciences
Here you’ll have the opportunity to make a meaningful difference to patients’ lives. With science at its heart, this is the place where breakthroughs born in the lab become transformative medicines – for the world’s most complex diseases. Answer unmet medical needs by pioneering the next wave of science, focusing on outcomes and shaping the patient ecosystem.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.