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- Tasks: Lead clinical data management, ensuring quality data for regulatory submissions and clinical trials.
- Company: Join Amgen, a pioneering biotech company dedicated to serving patients with serious illnesses since 1980.
- Benefits: Enjoy competitive benefits, a collaborative culture, and opportunities for personal and professional growth.
- Why this job: Make a lasting impact on patient lives while advancing your career in a dynamic, innovative environment.
- Qualifications: Degree in a relevant field with extensive experience in data management and leadership.
- Other info: Amgen values diversity and offers accommodations for applicants with disabilities.
The predicted salary is between 54000 - 84000 £ per year.
Career Category
Clinical
Job Description
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.
ASSOCIATE VICE PRESIDENT, CLINICAL DATA MANAGEMENT
Live
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.
Responsibilities:
- Develop and drive the global data management strategy in alignment with clinical development objectives and corporate goals.
- Provide strategic and operational leadership to the Clinical Data Management (CDM) function across all clinical programs and phases.
- Lead innovation initiatives, including the implementation of development integration programs and the adoption of cutting-edge technologies to enhance data workflows.
- Represent Clinical Data Management in executive leadership discussions, regulatory interactions, and industry forums.
- Establish and enforce robust clinical data governance models, policies, and risk mitigation strategies to ensure quality and compliance.
- Make final decisions regarding standard operating procedures (SOPs), CDM best practices, and process optimization.
- Engage key stakeholders and ensure timely resolution on critical data integrity and regulatory compliance issues.
- Serve as the primary CDM representative during regulatory inspections and audits, with responsibility for final decisions on findings, responses, and corrective actions.
- Influence cross-functional clinical development, operational, and regulatory strategies through data-driven insights and analytics.
- Partner closely with Clinical Program Operations, Regulatory, Biostatistics, and R&D to ensure seamless integration and alignment of clinical data.
- Build and maintain strategic relationships with CROs, vendors, regulatory authorities, and industry organizations to advance CDM excellence.
- Influence internal leadership and functional partners to promote data-driven decision-making across clinical programs.
- Lead audit readiness efforts and promote a culture of continuous improvement and compliance within the CDM function.
- Implement protocols and tools to ensure data security, integrity, and risk management across all platforms and studies.
- Optimize staffing, outsourcing strategies, and technology investments to improve cost-efficiency, scalability, and delivery timelines.
Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The candidate we seek is an experienced leader with the following qualifications.
Basic Qualifications:
- Degree educated in relevant discipline
- Extensive data management experience including managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
Preferred Qualifications:
- Experience within clinical data management, regulatory compliance, and strategic leadership within a pharmaceutical, biotech, or CRO environment.
- Expertise in GCP, ICH, FDA, EMA regulations, data governance, and clinical trial data standards (CDISC, SDTM).
- Experience within cross-functional collaborations, leadership, and strategic planning skills, ensuring operational excellence and compliance while driving innovation in data management to support Amgen\’s global clinical development efforts.
- Expertise in AI/ML-driven data management solutions, automation, and advanced analytics.
- Understanding of clinical data standards (CDISC, SDTM, ADaM).
- Experience leading regulatory submissions, including NDA/BLA/MAA filings and advisory committee interactions
- Proven ability to drive organizational change, optimize processes, and implement lean principles in clinical data management.
- Cross-functional collaboration experience with clinical operations, regulatory affairs, biostatistics, and R&D teams.
- Experience managing FSP relationships and technology implementations (EDC, CTMS, RWD/RWE).
- Knowledge of emerging trends in digital health, data governance, and data privacy regulations (GDPR, HIPAA).
- Familiarity with decentralized trial models and digital health technologies.
The successful candidate will also embody the Amgen leadership attributes which are:
- Inspire: Create a connected, inclusive, and inspiring work environment that empowers talent to thrive
- Accelerate: Enable speed that matches the urgency of patient needs by encouraging progress over perfection
- Integrate: Connect the dots to amplify the collective power of Amgen to drive results for patients, staff, and shareholders
- Adapt: Lead through change by adapting to an ever-changing environment and defining a clear course of action to deliver results
Thrive
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we\’ll support your journey every step of the way.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
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Associate Vice President, Clinical Data Management employer: Amgen, Inc.
Contact Detail:
Amgen, Inc. Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Associate Vice President, Clinical Data Management
✨Tip Number 1
Familiarise yourself with Amgen's mission and values. Understanding their commitment to serving patients and their focus on innovation will help you align your responses during interviews, showcasing how your personal values resonate with theirs.
✨Tip Number 2
Network with current or former employees of Amgen, especially those in Clinical Data Management roles. They can provide insights into the company culture and expectations, which can be invaluable when preparing for interviews.
✨Tip Number 3
Stay updated on the latest trends in clinical data management, particularly around AI/ML solutions and regulatory compliance. Being able to discuss these topics knowledgeably can set you apart as a candidate who is forward-thinking and well-informed.
✨Tip Number 4
Prepare to discuss your experience with cross-functional collaboration. Highlight specific examples where you've successfully worked with teams like clinical operations or biostatistics, as this role requires strong partnership skills across various departments.
We think you need these skills to ace Associate Vice President, Clinical Data Management
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in clinical data management, regulatory compliance, and leadership. Use specific examples that demonstrate your ability to manage teams and projects effectively.
Craft a Compelling Cover Letter: In your cover letter, express your passion for Amgen's mission and how your background aligns with the role. Mention your expertise in GCP, ICH, and FDA regulations, and how you can contribute to their innovative culture.
Highlight Leadership Experience: Emphasise any managerial roles or leadership experiences you've had, particularly in cross-functional collaborations. Showcase your ability to drive organisational change and promote data-driven decision-making.
Showcase Relevant Skills: Include specific skills related to AI/ML-driven data management solutions, automation, and advanced analytics. Mention your familiarity with clinical data standards and any experience with decentralized trial models.
How to prepare for a job interview at Amgen, Inc.
✨Understand the Role and Responsibilities
Before the interview, make sure you thoroughly understand the responsibilities of the Associate Vice President, Clinical Data Management. Familiarise yourself with clinical data management processes, regulatory compliance, and the strategic direction expected in this role.
✨Showcase Your Leadership Experience
Highlight your managerial experience and leadership skills during the interview. Be prepared to discuss specific examples of how you've led teams, managed projects, and driven organisational change in previous roles.
✨Demonstrate Knowledge of Regulatory Standards
Since the role involves ensuring compliance with global regulatory standards, be ready to discuss your expertise in GCP, ICH, FDA, and EMA regulations. Mention any relevant experiences with regulatory submissions and audits.
✨Emphasise Cross-Functional Collaboration
The position requires collaboration with various teams such as clinical operations, biostatistics, and regulatory affairs. Prepare examples that illustrate your ability to work effectively across different functions and how you’ve influenced data-driven decision-making.
