Director, Local Study Operations Manager

1001 Amgen Inc.; Thousand Oaks (CA); Híbrido; USD 196.000 - 265.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Retirement plan

Medical/dental/vision coverage

Life and disability insurance

Flexible spending accounts

Discretionary annual bonus

Stock-based long-term incentives

Generous time-off / paid leave

Descripción de la vacante

Amgen Inc. is seeking a Local Study Operations Manager (LSOM), Director, to provide strategic and operational leadership for the country LSOM organization, translating global clinical development strategy into country priorities.

You will oversee portfolio delivery, resource strategy, budget planning, quality, and vendor performance across feasibility to study close-out. You will lead LSOM Senior Managers and teams (FSP and FTE), build capability, ensure compliance with ICH GCP and regulatory

Formación

• Basic Qualifications: Doctorate degree with 4 years clinical research experience OR Master’s with 7 years OR Bachelor’s with 9 years.

Responsabilidades

• Lead LSOM Senior Managers and LSOM teams to optimize trial delivery.
• Ensure inspection readiness and provide hands-on support during inspections.
• Sponsor continuous operational improvement initiatives and share best practices.
• Collaborate with cross-functional stakeholders to align on trial deliverables and manage escalations.

Conocimientos

ICH GCP knowledge

Stakeholder influence

Project management

Clinical operations leadership

Educación

Doctorate degree

Master’s degree

Bachelor’s degree

Descripción del empleo

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. 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.

Local Study Operations Manager (LSOM), Director

Let’s do this. Let’s 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

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

• 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: 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

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

Benefits

• 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

• 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.

Equal Opportunity Employer

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.

Salary Range USD - USD Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen