Director, Local Study Operations Manager
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Job Description
Clinical operations director leading Amgen’s U.S. study portfolio, resources, vendors, and compliance. Driving execution of innovative biotech clinical trials from feasibility through close-out.
Responsibilities:
- Provide strategic and operational leadership for the country LSOM organization
- Oversee quality, timeliness, cost, and compliant execution of the country clinical study portfolio
- Translate global clinical development strategy into country operating priorities
- Direct portfolio delivery, resource and capacity strategy, financial planning, quality and risk management, vendor performance, and inspection readiness from feasibility through study close-out
- Influence study placement and portfolio decisions
- Lead resolution of significant operational issues
- Develop organizational capability and succession plans
- Represent LSOM operations in country, regional, and global governance forums
- Lead delivery of the country study portfolio through the LSOM management organization
- Establish portfolio-level oversight of delivery, quality, risk, timelines, and performance
- Manage LSOM and vendor performance and serve as the primary escalation point for local study challenges
- Build leadership capability through coaching, development, and succession planning
- Partner with CRA, CSPO, Quality, FSP, Regional Head, Country Head, and other cross-functional stakeholders
- Coordinate country functional teams for successful portfolio delivery
- Ensure inspection readiness and provide hands-on support during inspections, including responsibility for storyboards
- Sponsor continuous operational improvement, digital innovation, and adoption of leading practices
- Direct resource strategy, capacity planning, and workload allocation across FSP and FTE LSOM teams
- Ensure compliance with regulatory, GCP, ICH, quality, and organizational standards
- Lead, coach, and develop LSOM Senior Managers, including performance management and talent development
- Foster a high-performing, inclusive, accountable, and patient-focused culture across geographically distributed teams
- Lead organizational changes and adoption of new operating models and technologies
Requirements:
- Doctorate degree and 4 years of clinical research experience OR Master’s degree and 7 years of clinical research experience OR Bachelor’s degree and 9 years of clinical research experience
- 4 years of direct managerial and/or leadership experience or equivalent
- Deep knowledge of ICH GCP, ICH E6(R3), ICH E8(R1), and global regulatory expectations for risk-based monitoring and clinical trial oversight
- Proven ability to influence senior stakeholders and lead complex cross-functional initiatives within a global matrix organization
- Strong Project Management experience
- Experience managing multiple teams / direct reports across multiple clinical functions / trials
- Experience at, or oversight of, clinical research vendors (CROs, central labs, imaging vendors, etc.)
- Experience managing clinical operations across relevant geography / region
- Strong understanding of local regulatory requirements around global clinical trials
Benefits:
- Comprehensive employee benefits package
- Retirement and Savings Plan with generous company contributions
- Group medical, dental and vision coverage
- Life and disability insurance
- Flexible spending accounts
- Discretionary annual bonus program
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible
- Financial plans with opportunities to save towards retirement or other goals
- Career development opportunities
- Work/life balance support
- Reasonable accommodations for applicants and employees with disabilities
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