Global Development Scientist, Senior ManagerAccountabilities:- Clinical Strategy Translation: Support the conversion of disease strategy and target product profiles into study concepts, protocols and key study documents in partnership with the Clinical Project Team and Global Study Team.
- Protocol Development: Support the development of protocols and clinical plans, ensuring alignment with GCP, ICH and AstraZeneca quality standards.
- Trial Design and Delivery: Provide clinical/scientific input into early and late phase trials, including studies involving immunotherapy and cell therapy; partner with Clinical Operations to plan, recruit and deliver at pace, ensuring high-quality execution.
- Data Integrity and Interpretation: Support clinical data review and cleaning; deliver high-quality clinical study reports
- Regulatory Evidence and Submissions: Support the development of clinical content for global submissions (e.g., NDA/BLA) and lifecycle documents including Investigator's Brochure, DSUR, PSUR and regulatory responses to enable worldwide registration.
- Stakeholder Collaboration: Build strong internal networks across clinical, operations and quality, and form effective relationships external service providers to maintain momentum and resolve issues quickly.
- Site and Investigator Engagement: Provide timely responses to investigational sites on ICF changes and protocol questions; support the planning and delivery of effective investigator meetings and training to drive consistency and quality.
- Ethical and Compliance Leadership: Operate to the highest ethical standards in accordance with internal SOPs, local regulations and Good Clinical Practice.
Essential Skills/Experience:- BS required
- 0 to 2 years of relevant experience
- Industry or Academic experience in drug development required with experience in malignant haematology clinical trials strongly preferred
- Sufficient technical knowledge (haemato-oncology background preferred) to be able to interact with confidence with internal and external partner
- Possesses sound foundational knowledge of FDA and other major country regulations and detailed knowledge of Good Clinical Practice other regulations governing clinical research.
- Ability to drive/contribute to protocol design, writing and implementation
Desirable Skills/Experience:- Advanced degree (MS, PhD, PharmD, MD) in a relevant scientific or clinical discipline
- Direct experience with immunotherapy and/or cell therapy trials in hematologic malignancies
- Familiarity with translational biomarkers, novel endpoints, and innovative trial designs
- Experience with global, multicenter studies
- Strong publication record and scientific communication skills
- Proficiency in data-driven review methodologies and cross-functional decision forums
AstraZeneca CanadaAnnual base salary for this position ranges from 110,999.20 to 145,686.45.
AstraZeneca is committed to providing fair and equitable compensation opportunities to all colleagues. Our compensation policies and practices have been designed to allow colleagues to progress through the salary range over time as they progress in their role. The range provided in this posting represents an offer pay range used in a majority of situations. The base pay offered will vary depending on multiple individualized factors, including the candidate's skills and experience, job-related knowledge, and other specific business and organizational needs. In some cases, offers outside the range may also be considered to address unique circumstances.
In addition, our permanent positions offer an annual Variable Pay Bonus/Short Term Incentive opportunity as well as eligibility to participate in our equity-based long-term incentive program (if applicable to role). Benefits offered for permanent roles include a competitive Flex Benefits & Retirement Savings Program, 4 weeks' paid vacation, and annual Personal Days. Fixed Term Contract/Temporary positions (excluding students) are offered a Contract Benefits Program.
We are using AI as part of the recruitment process.
This advertisement relates to a current vacancy.
