ABOUT AMGEN
Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today.
ABOUT THE ROLE
Clinical Data Hub
Amgen’s Clinical Data Hub (CDH) is an Information Technology product team chartered to identify, design and implement technology that powers Amgen’s end‑to‑end drug development lifecycle. We are at an inflection point, accelerating through rapid, AI‑driven modernization to build clinical data products that enable both drug regulatory submissions and drug discovery and development. If you’re passionate about turning complex clinical data into resilient, scalable products that help speed life‑changing medicines to patients worldwide, this is a once‑in‑a‑decade opportunity to do your career‑best work on a global stage.
Role Description:
This role is pivotal in shaping and driving the overall validation strategy within the Clinical Design and Analysis technology services group. This role will serve as the subject matter expert for validation processes, ensuring compliance with regulatory standards and best practices throughout the technology lifecycle. By mentoring and guiding validation team members, this individual will foster a culture of quality and continuous improvement as the group builds and transforms technology capabilities that directly impact business outcomes. Their leadership will be instrumental in developing and managing a highly skilled team of validation engineers, empowering them to deliver innovative and robust technology solutions that support biostatistical study design and analysis, while maintaining rigorous validation standards.
The ideal candidate must demonstrate deep expertise in validation management, with a proven track record of leadership in technology-driven environments for clinical design and analysis. A passion for fostering innovation and excellence in the biotechnology industry is essential. Collaborate extensively with cross-functional and global teams to ensure seamless integration, operational excellence, and compliance across all deliverables. Candidates must have a strong background in the end-to-end software development lifecycle, particularly within a Scaled Agile Framework, will enable them to champion validation requirements, drive transformation, and support key organizational strategic initiatives. Success in this position requires the ability to cultivate a collaborative environment, uphold high-quality validation standards, and deliver results within a matrixed organizational structure.
Roles & Responsibilities:
- Establish and drive the validation strategy for clinical design and analysis technology services, ensuring alignment with organizational goals and regulatory standards.
- Act as the subject matter expert for validation processes, maintaining compliance with regulatory requirements and industry best practices throughout the technology lifecycle.
- Oversee and enhance quality assurance activities, ensuring rigorous validation standards are upheld across all technology solutions and deliverables.
- Mentor and guide validation team members, fostering a culture of quality, compliance, and continuous improvement within the group.
- Lead process improvement initiatives, identifying opportunities to optimize validation procedures and enhance operational efficiency.
- Develop and manage a skilled team of validation engineers, empowering them to deliver innovative and robust technology solutions that support biostatistical study design and analysis.
- Collaborate with cross-functional and global teams to ensure seamless integration of validation requirements and operational excellence across all deliverables.
- Monitor and review validation documentation, audits, and compliance activities, ensuring timely resolution of issues and adherence to regulatory guidelines.
- Foster a culture of collaboration, innovation, and continuous improvement.
- Attract and recruit top talent as part of an extensive Technology organization to be hired within India.
- Collaborate with geographically dispersed teams, including those in the US and other international locations.
- Understand the decision-making process, workflows, and business and information needs of business partners and stakeholders
- Improve activities being measured by crafting, monitoring, and optimizing relevant feedback loops through 'test & learn' activities
- Ensure communication of key performance metrics and analysis of unmet needs
- Work with Product Owners, Service Owners and/or delivery teams to ensure that delivery matches commitments, acting as an escalation point and facilitating communication when service commitments are not met
- Participate in stakeholder and other leadership meetings, working with other parts of the organization, and functional groups to ensure successful delivery
- Maintain strategic relationships and strong communication with the leadership team about IS services and service roadmaps to ensure that all the stakeholders feel informed and engaged
- Follow global standards and practices.
- Ensure ongoing alignment with strategy, compliance, and regulatory requirements for technology investments and services
- Facilitate best practice sharing, ensuring ongoing alignment with the Technology & Digital strategy
- Oversee operating budgets and product team budgets, ensuring regular review of actuals and latest estimates, managing according to agreed governance
- Ensure alignment of Technology service plans across organization
- Provide education to new partners with regards to IT service offerings
- Remain accountable for ensuring overall organizational compliance to quality/compliance requirements such as GXP and Privacy
Basic Qualifications and Experience:
- Doctorate Degree and 2 years of experience in Life Sciences Information Technology Management or related field OR
- Master’s degree with 8 - 10 years of experience in Life Sciences Information Technology Management or related field OR
- Bachelor’s degree with 10 - 14 years of experience in Life Sciences Information Technology Management or related field OR
- Diploma with 14 - 18 years of experience in Life Sciences Information Technology Management or related field
Functional Skills:
Must-Have Skills:
- Solid understanding of GxP regulations, specifically 21 CFR Part 11.
- Expertise in defining and executing validation strategies aligned with regulatory requirements.
- Experience in people management and leading matrixed teams, and passion for mentorship, culture and fostering the development of talent.
- Demonstrated experience in managing technology teams and innovations with a track record of successful innovation
- Must be flexible and able to manage multiple activities and priorities with minimal direction in a rapidly changing and demanding environment.
- Exceptional collaboration, communication and interpersonal skills to effectively manage stakeholder relationships and build new partnerships.
Good-to-Have Skills:
- Solid understanding of biostatistical analysis methods, clinical pharmacology, and clinical pharmacokinetic analyses
- Experience in a leadership role within a pharmaceutical or technology organization
- Experience using and adoption of Scaled Agile Framework (SAFe)
- Ability to work effectively in a fast-paced, dynamic environment.
- Established business partnerships and IS governance practices involving senior business stakeholders
- Proficiency in automation tools, data systems, and validation software (Application Lifecycle Management and/or Veeva Vault Validation Management)
Professional Certifications:
- Scaled Agile Framework (SAFe) for Teams (preferred)
Soft Skills:
- Strong verbal and written communication skills
- Team-oriented with a focus on achieving team goals.
- Excellent leadership and team management skills.
- Strong transformation and change management experience.
- Exceptional collaboration and communication skills.
- High degree of initiative and self-motivation.
- Ability to manage multiple priorities successfully.
- Excellent analytical and troubleshooting skills
- Ability to work effectively with global, virtual teams
Shift Information:
This position requires you to work a later shift and may be assigned a second or third shift schedule. Candidates must be willing and able to work during evening or night shifts, as required based on business requirements.
EQUAL OPPORTUNITY STATEMENT
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided with 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 an accommodation.
