US Director of Clinical Site Monitoring and Oversight

Career Category

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. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. 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.

US Director of Clinical Site Monitoring and Oversight

What you will do

Let’s do this. Let’s change the world. In this vital role you will be the strategic leadership and oversight for Amgen’s clinical site monitoring in the US. This role is accountable for defining, implementing, and continuously evolving innovative monitoring strategies that ensure patient safety, data integrity, protocol compliance, and operational excellence. This leader drives strategic transformation of monitoring practices through analytics, technology innovation, and operational excellence while ensuring consistent oversight and inspection readiness across all clinical programs.

Accountabilities

• Define and lead Amgen’s US clinical site monitoring strategy, ensuring alignment with corporate quality objectives, regulatory expectations, and industry best practices.

• Establish and maintain enterprise standards for on-site, remote, centralized, and risk-based monitoring activities across all clinical programs.

• Ensure strategy and execution of field monitoring excellence optimizing central monitoring.

• Drive the evolution of monitoring methodologies through the incorporation of advanced analytics, automation, AI-enabled insights, and innovative oversight approaches.

• Serve as the monitoring strategy business process owner (BPO) and subject matter expert (SME) for senior leadership, governance committees, inspections, audits, and regulatory interactions.

• Collaborate with Clinical Operations leadership to ensure monitoring strategies are integrated into study planning, execution, and oversight models.

• Build and oversee a team of internal and FSP clinical research associates (CRAs)

• Lead the strategic implementation and continuous enhancement of risk-based monitoring approaches across the portfolio.

• Partner with Clinical Risk, Compliance & Systems teams to ensure alignment between monitoring strategies, Critical to Quality (CTQ) factors, Key Risk Indicators (KRIs), Quality Tolerance Limits (QTLs), centralized monitoring and monitoring oversight activities.

• Oversee associated procedures and governance of monitoring plans, ensuring monitoring intensity and methodologies are appropriately tailored to study risks.

• Drive consistency in monitoring practices.

CRO and Vendor Oversight

• Establish a monitoring oversight process to ensure oversight processes proactively identify, escalate, and mitigate emerging quality, compliance, and operational risks.

• Provide strategic oversight of CRO monitoring performance, ensuring alignment with Amgen standards, ICH GCP, quality expectations, and contractual obligations.

• Establish monitoring performance metrics, dashboards, and governance frameworks to assess effectiveness, efficiency, and quality outcomes.

• Lead escalation and resolution of systemic monitoring issues, compliance concerns, and performance trends.

• Partner with Alliance (Vendor) Management and Clinical Operations to optimize monitoring delivery models and oversight practices.

Responsibilities

• Serves as the functional leader for US clinical monitoring strategy and execution, integrating risk-based, centralized, remote and other monitoring approaches in partnership with relevant cross-functional capabilities.

• Partners closely with Clinical Operations, Clinical Risk & Compliance, Data Management, Biostatistics, Medical, Quality, and FSP partners

• Ensures monitoring approaches are aligned with regulatory expectations, ICH GCP, quality objectives, and Amgen’s commitment to Quality by Design.

Capability Building & People Leadership

• Lead, coach, and develop CRA leaders, including performance management, succession planning, and leadership bench development.

• Build the organizational capabilities, resourcing, and operating model needed to meet current and future regional portfolio requirements.

• Foster a high-performing, inclusive, accountable, and patient-focused culture across geographically distributed teams.

• Lead organizational changes and enable adoption of new operating models, technologies, monitoring approaches, and clinical development practices.

Authority

• Accountable for regional level oversight and delivery of clinical trials.

• Holds line management authority for regional and country operations leaders, including performance management, talent development, succession planning, and capability building.

• Sets regional delivery goals, operating expectations, and performance standards across study start-up, site engagement, monitoring, execution, and closeout.

• Capability build, talent and performance management, and acting as a liaison for cultural differences within region.

Outputs

• In partnership with GSSO leadership, establish and implement strategies to increase and sustain high performance and quality in monitoring activities. Develop and implement frameworks for monitoring performance metrics, provide strategic leadership to field monitoring teams, establishing monitoring best practice and standards, ensuring consistency across Hubs and countries.

• In partnership with Data Management, ensure centralized/analytical monitoring capabilities continue to evolve as a value-added component of the overall monitoring and RBQM strategy.

• High-performing regional/country team.

What we expect of you

Basic Qualifications:

• 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

Preferred Qualifications:

• Minimum of 12 years of experience in clinical research, clinical operations, clinical quality, or related functions, including significant experience leading clinical monitoring strategy and oversight in global clinical trials.

• Deep knowledge of ICH GCP, ICH E6(R3), ICH E8(R1), and global regulatory expectations for risk-based monitoring and clinical trial oversight.

• Demonstrated success developing and implementing monitoring strategies across multiple therapeutic areas and phases of development.

• Strong expertise in risk-based monitoring, centralized monitoring, remote monitoring, and CRO oversight models.

• Experience utilizing clinical analytics, RBQM platforms, monitoring technologies, and data visualization tools to drive risk-based decision making.

• Proven ability to influence senior stakeholders and lead complex cross-functional initiatives within a global matrix organization.

• Strong leadership, change management, relationship management, and organizational development capabilities.

• Excellent communication, presentation, and stakeholder management skills.

• Ability to travel up to 25%.

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.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

Base Salary Range: $$195,876-265,008

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

Apply now and make a lasting impact with the Amgen team.

careers.amgen.com

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Application deadline

External/Internal postings:

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of 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. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law.

We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation.

Salary Range

Originally posted on Himalayas