Global Development Scientist, Senior Manager
About The Position
The Global Development Scientist, Senior Manager will 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. This role involves supporting the development of protocols and clinical plans, ensuring alignment with GCP, ICH, and AstraZeneca quality standards. The position provides clinical/scientific input into early and late phase trials, including studies involving immunotherapy and cell therapy, and partners with Clinical Operations to plan, recruit, and deliver at pace with high-quality execution. Responsibilities also include supporting clinical data review and cleaning, delivering high-quality clinical study reports, and supporting the development of clinical content for global submissions and lifecycle documents. The role requires building strong internal networks and forming effective relationships with external service providers, as well as providing timely responses to investigational sites and supporting the planning and delivery of effective investigator meetings and training. The position operates to the highest ethical standards in accordance with internal SOPs, local regulations, and Good Clinical Practice.
Requirements
- BS required
- 0 to 2 years of relevant experience
- Industry or Academic experience in drug development required
- Sufficient technical knowledge 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
Nice To Haves
- 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
- Experience in malignant haematology clinical trials strongly preferred
- Haemato-oncology background preferred
Responsibilities
- 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.
- Support the development of protocols and clinical plans, ensuring alignment with GCP, ICH and AstraZeneca quality standards.
- 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.
- Support clinical data review and cleaning; deliver high-quality clinical study reports.
- 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.
- Build strong internal networks across clinical, operations and quality, and form effective relationships external service providers to maintain momentum and resolve issues quickly.
- 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.
- Operate to the highest ethical standards in accordance with internal SOPs, local regulations and Good Clinical Practice.
Benefits
- Annual base salary for this position ranges from 110,999.20 to 145,686.45.
- Annual Variable Pay Bonus/Short Term Incentive opportunity
- Eligibility to participate in our equity-based long-term incentive program (if applicable to role).
- Competitive Flex Benefits & Retirement Savings Program
- 4 weeks’ paid vacation
- Annual Personal Days
- Contract Benefits Program (for Fixed Term Contract/Temporary positions excluding students)
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
