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170 AstraZeneca Jobs
Global Development Associate Medical Director II
4-9 years
Bangalore / Bengaluru
1 vacancy
Global Development Associate Medical Director II
AstraZeneca
posted 2d ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
Accountabilities Essential Skills/Experience
- Supports in evaluating the risk-benefit of a clinical study, ensuring that all clinical studies operate to the highest ethical and safety standards and in compliance FDA, EMEA, ICH and GCP guidelines as well as SOPs regarding safety.
- 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 (such as Global ICF, CRF, TFL shells, etc)
- Supports drafting and review of clinical scientific documents such as IND, IND amendments, Investigator Brochures, Annual Reports and other Health Authority submissions.
- Participates in the development of producing materials for investigator meetings (e.g., slides, booklets, and presentation materials), addressing questions regarding scientific and protocol procedures from other study team members and investigative sites.
- 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, and interpretation of study results, and inform recruitment strategies.
- Contributes to the development of medical oversight plan (MOP) and lead or contribute to the study-level medical monitoring activities accordingly, e.g, monitoring the scientific conduct of the study and safety and efficacy data review and cleaning.
- Member of the GST representing Clinical Development.
Technical Skills
- Drug Development/Clinical Development Planning: Demonstrates the ability to contribute to 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 contribute to protocol design, writing and implementation to meet GCP, ICH and all AZ quality standards.
- Demonstrates understanding of methodology in the design, conduct, review and interpretation, and presentation of clinical research.
- Effectively organizes content and rationales in assigned sections of clinical reports or regulatory/EC/IRB documents(i.e. CTA, briefing book, BLA/NDA).
- Contributes to the preparation and presentation of clinical data and/or selected training sessions to internal/external groups.
- Required M.D or MD./Ph.D. degree or equivalent. Strong preference for individuals with clinical training in oncology
- Industry or academic experience in drug development required.
- Possesses detailed knowledge of Good Clinical Practice (GCP) and other regulations governing clinical research.
- Possesses 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
Key Relationships to reach solutions
Internal (to AZ or team)
- Global Development Scientists
- Director Clinical Development & Associate Director Clinical Development
- Global Study Team and providers of services to the study team
- Clinical Project Team / Global Product Team
- Global Clinical Program Leaders
- Global Clinical Heads
- Medical Science Liaisons (MSLs)
- Site Management & Monitoring
- Patient Safety
- Publications/Communication teams
- Other functional leaders ( GPL, GPS, GRL, etc.)
External (to AZ)
- External service providers
- Investigators and site staff
- Key External Experts
- Ethic Committees/Institutional Review Boards
- Regulatory Authorities
Employment Type: Full Time, Permanent
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What people at AstraZeneca are saying
Associate Director Medical salary at AstraZeneca
reported by
2
employees
with 10-13
years exp.
₹50.4
L/yr - ₹55.6
L/yr
61%
more
than the average Associate Director Medical Salary in India
View more details
What AstraZeneca employees are saying about work life
based on 819 employees
Flexible timing
Monday to Friday
No travel
Day Shift
AstraZeneca Benefits
View more benefits
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