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Sr. Global Development Scientist Director Late Oncology
Company | AstraZeneca |
Address | Mississauga, Ontario, Canada |
Employment type | FULL_TIME |
Salary | |
Category | Pharmaceutical Manufacturing |
Expires | 2023-07-21 |
Posted at | 11 months ago |
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.
- 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.
- Contributes to technical review of protocols with governance bodies such as DRC and PRC.
- 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.
- Responsible for the relevance and accuracy of clinical science underpinning of clinical study based on detailed scientific review and consultation.
- Responsible for the clinical and scientific input into a study and for the quality of the clinical data
- 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.
- 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.
- Contribute to advisory boards to ensure there is engagement with site specific KEEs to ensure robust study designs, recruitment strategies.
- Contributes to the development of Medical Oversight Plan (MOP), study level safety reviews and study-level medical monitoring activities.
- 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.
- General knowledge of 1) medical monitoring 2) Regulatory approval process in relevant countries; 3) pharmaceutical industry/R&D operations; 4) marketing and commercial fundamentals.
- Detailed knowledge of GCP and other regulations governing clinical research.
- Bachelor’s degree with focus on life sciences or equivalent
- Industry or academic experience in drug development
- 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 grow and maintain a high level of expertise in oncology therapeutic area.
- Emerging leadership skills with the ability to influence others and drive consensus building
- Strong experience with regulatory submission and related activities
- 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
- Ph.D. degree in life sciences
- Oncology experience
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