Start Date
Immediate
Expiry Date
11 Nov, 25
Salary
0.0
Posted On
11 Aug, 25
Experience
0 year(s) or above
Remote Job
Yes
Telecommute
Yes
Sponsor Visa
No
Skills
Regulatory Interactions, Emerging Trends, Strategic Leadership, Cross Functional Collaborations, Automation, Regulatory Submissions, Clinical Operations, Mitigation Strategies, Teams, Privacy Regulations, Regulatory Affairs, Lean Principles, Data Governance
Industry
Pharmaceuticals
JOIN AMGEN’S MISSION OF SERVING PATIENTS
At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.
Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
PREFERRED QUALIFICATIONS:
EXPERIENCE LEADING REGULATORY SUBMISSIONS, INCLUDING NDA/BLA/MAA FILINGS AND ADVISORY COMMITTEE INTERACTIONS
KNOWLEDGE OF EMERGING TRENDS IN DIGITAL HEALTH, DATA GOVERNANCE, AND DATA PRIVACY REGULATIONS (GDPR, HIPAA).
The successful candidate will also embody the Amgen leadership attributes which are:
WHAT YOU WILL DO
The Associate Vice President, Clinical Data Management is a member of the Global Development Operations (GDO) leadership team and is a strategic partner to the R&D organization.
You will lead Amgen’s Clinical Data Management function within GDO, ensuring the highest quality of clinical data collection, processing, and analysis to support regulatory submissions and clinical development programs. This role is responsible for the strategic direction, leadership, and operational oversight of data management processes supporting clinical trials across all therapeutic areas and phases.
You will collaborate closely with cross-functional teams including clinical operations, biostatistics, regulatory affairs, and quality to drive data integrity and compliance with global regulatory standards.
The role requires a visionary leader with deep expertise in CDM and a proven ability to scale and lead global teams in a complex matrix environment.