✅ Job Title:
Associate Vice President (AVP), Clinical Data Management
🏢 Company:
Amgen
📍 Location:
Hyderabad, India
(On-site role)
📅 Date Posted:
August 11, 2025
🔢 Job ID:
R-222164
🧪 Job Category:
Clinical
🌍 Work Location Type:
On Site
🎯 About Amgen:
Since 1980, Amgen has been a pioneer in biotechnology, focused on serving patients suffering from serious illnesses. The company operates in four key therapeutic areas:
Oncology
Inflammation
General Medicine
Rare Disease
With millions of patients impacted annually, Amgen’s mission is to improve lives through innovative medicines and groundbreaking science.
🌐 Website: www.amgen.com
💼 Position Summary:
The Associate Vice President, Clinical Data Management (CDM) is a key member of the Global Development Operations (GDO) leadership team and a strategic partner to the R&D organization.
This leader is responsible for the strategic direction, leadership, and operational oversight of global data management processes across all clinical development programs and therapeutic areas.
🛠️ Key Responsibilities:
Strategy & Leadership:
Develop and drive global CDM strategy aligned with Amgen’s clinical and corporate objectives.
Lead innovation in data management including AI/ML technologies and digital health tools.
Operations & Execution:
Ensure high-quality clinical data collection, processing, and analysis for regulatory submissions.
Oversee CDM SOPs, best practices, data governance, and quality standards.
Collaboration & Representation:
Act as the CDM lead during regulatory inspections and audits.
Represent CDM in executive leadership meetings, regulatory bodies, and industry forums.
Risk Management & Compliance:
Implement risk mitigation strategies and ensure compliance with global standards (GCP, ICH, FDA, EMA).
Ensure readiness for inspections and drive a culture of continuous improvement.
Resource & Vendor Management:
Optimize staffing, outsourcing strategies (e.g., FSP), and technology investments.
Manage CROs, vendors, and cross-functional partnerships (Regulatory, Biostatistics, Clinical Ops).
📚 Basic Qualifications:
Bachelor’s or Master’s Degree
25+ years of experience in Clinical Data Management
10 to 15 years of leadership or managerial experience
🌟 Preferred Qualifications:
Deep knowledge of:
GCP, ICH, CDISC, SDTM, ADaM, FDA/EMA regulations
Data governance, audit readiness, and regulatory compliance
Expertise in:
AI/ML, automation, digital trials, decentralized models
Advanced analytics & clinical data standards
Proven leadership in:
Large global teams, CRO/vendor partnerships, cross-functional collaboration
Organizational change, process optimization, and lean implementation
Experience in:
Regulatory submissions (NDA/BLA/MAA)
Technology platforms (EDC, CTMS, RWD/RWE)
💡 Leadership Attributes:
Inspire: Build a connected, inclusive, and high-performing team culture
Accelerate: Act with urgency and drive results with focus on patients
Integrate: Collaborate across functions to maximize impact
Adapt: Embrace change and provide clarity in complex environments
🎁 What You Can Expect at Amgen:
A collaborative, science-driven culture
Opportunities to make a lasting impact on global health
Inclusive work environment with competitive benefits
Commitment to professional growth and well-being
♿ Equal Opportunity Employer:
Amgen is committed to diversity, equity, and inclusion. Reasonable accommodations will be provided for individuals with disabilities during the application, interview, and employment process.
📩 Application Process:
No deadline; applications accepted until the position is filled
Apply through Amgen Careers
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Detroit | Houghton Lake | Macomb | Southfield |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Missouri :
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China | Quarry Bay |Hubei :
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