Job Title: Global Development Medical Director
Job ID: R-217297
Date Posted: 01/16/2025
Career Level: F
Employer: AstraZeneca
Are you ready to drive innovation in cardiovascular disease treatments and improve patients' lives? As a Global Development Medical Director, you will play a pivotal role in providing medical expertise across product maintenance, regulatory activities, and clinical development. You will contribute to periodic reporting, license renewals, regulatory responses, and global clinical development activities, all while adhering to the highest ethical and regulatory standards.
Medical & Global Medicines Development (GMed) Activities:
Provide medical input to Periodic Safety Update Reports (PSURs), Periodic Benefit Risk Evaluation Reports (PBRERs), annual New Drug Application (NDA) reports, license renewals, labeling, and regulatory responses in collaboration with cross-functional teams under the direction of the Global Clinical Head (GCH).
Cross-Functional Collaboration:
Work with international teams and external Alliance partners on development initiatives and regulatory issues, applying AstraZeneca's strategic intent in communications with regulatory authorities, payers, opinion leaders, and prescribers.
Medical Expertise & Leadership:
Serve as a medical expert for the Product Team and mentor investigator-initiated trials in alignment with regional marketing companies. Act as a Global Clinical Leader delegate for assigned tasks.
Risk Management & Mitigation:
Identify potential risks related to clinical development and propose strategies for mitigation to ensure successful execution of Phase III or Life Cycle Management (LCM) studies and License-to-Operate tactics.
Compliance & Ethical Standards:
Ensure compliance with AstraZeneca’s internal SOPs, local regulations, and Good Clinical Practice (GCP) in all activities, while maintaining the highest ethical standards.
Medical Qualifications:
Graduate of a recognized medical school with an M.B.B.S., M.D., or equivalent scientist degree.
Clinical Research Experience:
3-5 years of experience in clinical research within the relevant therapy area or CRO experience.
Knowledge & Expertise:
Good understanding of biostatistics, the global regulatory environment, and pharmacovigilance.
Communication & Collaboration:
Proficient in oral and written English, with strong presentation skills. Ability to build partnerships and collaborate effectively, both internally and externally.
Leadership & Agility:
Demonstrated leadership abilities with a focus on trust and collaboration in diverse settings. Agile in responding to data and providing credible input in scientific and commercial environments.
Advanced Degree:
A PhD in a scientific field is a plus.
Specialized Training:
Education in Pharmaceutical Medicine, and specialty training in cardiology or endocrinology is beneficial. However, candidates with validated experience in other relevant areas may also be considered.
R&D Knowledge:
Understanding of pharmaceutical industry R&D, including key clinical turning points and factors influencing drug development.
Safety & Regulatory Awareness:
Knowledge of the interplay between drug safety and regulatory requirements.
AstraZeneca values collaboration and believes that in-person working sparks creativity and progress. The expectation is to work at least three days per week in the office, while offering flexibility to meet individual needs. This hybrid model fosters a balance of in-person interaction and remote work.
Commitment to Innovation:
Join a leading company in the cardiovascular field, where your work will directly impact patient outcomes and contribute to one of the broadest and most advanced pipelines in the industry.
Inclusive Culture:
AstraZeneca embraces diversity and equality, building inclusive teams that reflect the patients we serve. We believe diverse perspectives enhance our creativity and innovation.
If you're ready to make a transformative difference in the lives of patients with cardiovascular diseases, apply now to join AstraZeneca and shape the future of medical development.
AstraZeneca is committed to creating an inclusive and diverse environment. We encourage applications from all qualified candidates, regardless of background, gender, ethnicity, or other characteristics. We adhere to all relevant non-discrimination laws and regulations.
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