Director, Local Study Operations Manager

BioSpace; Washington (District of Columbia); On-site; USD 196,000 - 265,000; Full time

Benefits offered by this job

Retirement plan

Stock-based incentives

Discretionary bonus program

Flexible work models where possible

Job summary

Amgen is seeking a Local Study Operations Manager (LSOM), Director, to lead the country LSOM organization and oversee the study portfolio from feasibility through close-out. You will guide LSOM Senior Managers and partners, ensure quality, timelines, budget, and regulatory compliance across the country.

You will drive cross-functional collaboration with CRAs, quality, CSPO, and vendor partners, develop capability and succession plans, and align local execution with global development priorities.

Qualifications

• Doctorate/Master’s/Bachelor’s as required by role.
• Strong leadership and people management skills.
• Experience in clinical research operations and vendor management.
• Deep knowledge of ICH GCP and global regulatory expectations.

Responsibilities

• Provide strategic and operational leadership for country LSOM organization.
• Direct portfolio delivery, resource strategy, and budget planning.
• Ensure compliance with regulatory standards and quality metrics across country portfolio.
• Coach LSOM Senior Managers and develop succession plans.
• Collaborate with CRA, CSPO, Quality, and FSP vendors to support trial execution.

Skills

Leadership

Strategic planning

Cross-functional collaboration

Budget management

Regulatory knowledge

Education

Doctorate degree

Masters degree

Bachelors degree

Job description

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Local Study Operations Manager (LSOM), Director

What you will do

Lets do this. Lets change the world. In this vital role you will provide strategic and operational leadership for the country LSOM organization and is accountable for the quality, timeliness, cost, and compliant execution of the country clinical study portfolio. The role achieves results through LSOM Senior Managers and their FTE and FSP teams, translating global clinical development strategy into country operating priorities. The role directs portfolio delivery, resource and capacity strategy, financial planning, quality and risk management, vendor performance, and inspection readiness from feasibility through study close-out. As a member of the country leadership team, this role influences study placement and portfolio decisions, leads the resolution of significant operational issues, develops organizational capability and succession plans, and represents LSOM operations in country, regional, and global governance forums.

Accountabilities

• Lead the successful delivery of the country study portfolio through the LSOM management organization, ensuring alignment with global clinical development priorities.
• Provides strategic direction and leadership to LSOM country organization across the full study lifecycle, including feasibility, study execution, and study close-out.
• Establishes portfolio-level oversight of delivery, quality, risk, timelines, and performance, directing timely escalation and resolution of critical issues for LSOM management organization.
• Manage LSOM and LSOM vendor performance to guarantee high-quality study execution, serving as the primary escalation point for local study challenges, driving solutions, and ensuring portfolio targets are met within the country.
• Build leadership capability within the LSOM organization through targeted coaching, development, and succession planning, preparing LSOMs to lead increasingly complex trials and programs.
• Establishes strong operating partnerships with Clinical Research Associate (CRA) organization to support study start-up, monitoring, issue resolution, and compliant trial execution across the country portfolio.
• Cultivate a high-performing, accountable, and inclusive organization focused on operational excellence and continuous improvement.
• Champion strong integration between study strategy and local execution teams to translate portfolio priorities into effective country-level delivery.
• Strengthen cross-functional alignment and accountability across country teams to accelerate execution and deliver portfolio commitments.
• Influences study-placement and portfolio investment decisions by providing strategic insight into country's capabilities, operational readiness, performance, and growth potential.
• Anticipates portfolio-level delivery risks, quality trends, and evolving resource requirements, directing mitigation strategies and systemic improvements across country operations.
• Sponsor initiatives that advance operational efficiency, digital innovation, organizational capability, and the adoption of leading practices.
• Direct resource strategy, capacity planning, and workload allocation across FSP and FTE LSOM teams to optimize execution and align resources with global priorities.
• Ensure compliance with applicable regulatory, GCP, ICH, and organizational standards across the country's study portfolio.
• Partner with the Regional Head/Country Head and senior cross-functional stakeholders to align priorities, establish accountability for trial deliverables, and resolve significant escalations.

Responsibilities

• Serve as the functional leader for LSOM Senior Managers and the broader LSOM team, including both FSP and FTE, to optimize trial execution and align with global priorities. including strategy and execution, managing risks and escalations
• Partners closely with CRAs, CSPO, Quality, and FSP partners.
• Leads the coordination among country functional teams to ensure successful delivery of the country portfolio.
• Ensure inspection readiness and provide hands-on support during inspections, including responsibility for storyboards.
• Sponsors continuous operational improvement initiatives and encourage sharing of best practices.
• Ensure compliance with relevant regulatory and quality standards.
• Collaborate with the Regional Head/Country Head to engage cross-functional stakeholders, align on trial deliverables, and manage escalations as needed.

Capability Building and People Leadership

Lead, coach, and develop LSOM Sr Managers, including performance management, succession planning, and leadership bench development.

Build the organizational capabilities, resourcing needed to meet the 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

Authority

Accountable for country level oversight and delivery of clinical trials.

Manage the performance of LSOM Senior Managers and their teams

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

• Manage LSOM resources in accordance with the global study strategy.
• Oversee resource allocation and workload balance across LSOMs.
• Handle FSP supplier resource coordination and monitor performance through quality oversight metrics.
• Identify and report any risks or compliance concerns related to FSP activities.
• Escalate issues to the Regional/Country Head as necessary.

What we expect of you

• Doctorate degree and 4 years of clinical research experience OR
• Masters degree and 7 years of clinical research experience OR
• Bachelors degree and 9 years of clinical research experience

Preferred Qualifications

• 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, including strong understanding of local regulatory requirements around global clinical trials

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, well 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.

Application deadline

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.

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.