Director, Local Study Operations Manager

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.

Lets do this. Lets change the 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 countrys 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 countrys 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

Basic Qualifications:

• 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

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: $08

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.

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.

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 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