Global Development Scientist, Senior Manager

Global Development Scientist Senior Manager

Accountabilities:

• 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 Investigators 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 Canada

WHY JOIN US

At AstraZeneca were dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. Theres no better place to make a difference to medicine patients and society. An inclusive culture that champions diversity and collaboration and always committed to lifelong learning growth and development. Were on an exciting journey to pioneer the future of healthcare.

SO WHATS NEXT

To be considered for this exciting opportunity please complete the full application on our website at your earliest convenience it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit please share this posting with them.

Recognizing the importance of individualized flexibility our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office is purposely designed with collaboration in mind providing space where teams can come together to strategize brainstorm and connect on key projects.

Great People want to Work with us! Find out why:

• GTAA Top Employer Award for 10 years
• Top 100 Employers Award
• Canadas Most Admired Corporate Culture
• Learn more about working with us in Canada
• View our YouTube channel

Are you interested in working at AZ apply today!

AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment assessment and selection process and may be requested by emailing.

Annual base salary for this position ranges from 110999.20 to 145686.45.

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 candidates skills and experience job-related knowledge and other specific business and organizational 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.

Required Experience:

Senior Manager

Employment Type : Full-Time
Experience: years
Vacancy: 1