Director Global Site & Study Operations Job at Amgen (Uxbridge)

Director Global Site & Study Operations

In this vital role, you will provide strategic and operational leadership for st...

Location

United Kingdom , Cambridge; London; Uxbridge

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Degree educated
Clinical trial execution experience and previous people leadership managing teams, projects, or resources
Previous experience in life sciences or a related field, including biopharmaceutical clinical research
Experience working with or overseeing clinical research vendors (e.g., CROs, central labs, imaging)
Strong experience leading clinical operations across a country or region, with knowledge of local regulatory requirements

Job Responsibility

Owning end-to-end study and site execution, including start-up, enrollment, retention, data quality, and patient safety
Advising on country commitments, feasibility, site selection, and study placement aligned with portfolio priorities
Leading, developing, and resourcing country or hub teams to meet current and future portfolio needs
Driving strong investigator and site engagement through a differentiated Amgen site experience
Managing country-level budgets, forecasting, and vendor performance to ensure efficient use of resources
Leading country governance and risk management, including chairing the Country Management Team and representing the country in senior forums
Ensuring regulatory compliance, inspection readiness, and continuous improvement, promoting best-practice sharing, audit readiness, and adherence to ICH-GCP, SOPs

What we offer

Clear and disciplined strategic vision for the future that leverages superior-quality products, operational excellence and top-shelf-talent
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

US Country Head, Global Study & Site Operations Director

Join Amgen’s Mission of Serving Patients. Provide strategic and operational lead...

Location

United States

Salary:

211385.00 - 252852.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 4 years of clinical execution experience
Master’s degree and 8 years of clinical execution experience
Bachelor’s degree and 10 years of clinical execution experience
At least 4 years’ experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources
+10 years’ work experience in life sciences or medically related field, including 8 years of biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company)
Experience at, or oversight of, clinical research vendors (CRO’s, central labs, imaging vendors, etc.)
Significant experience managing clinical operations across relevant geography / region, including strong understanding of local regulatory requirements around global clinical trials

Job Responsibility

Provide strategic and operational leadership for all study and site execution within the assigned country or hub-and-spoke geography
Accountable for end-to-end study, site, and site engagement execution across the assigned country or hub-and-spoke geography
Provide strategic leadership for country commitments, acting as a key advisor on study feasibility, placement, and site selection
Lead, line-manage, and develop the Country/Hub team
Ensure adequate and timely resourcing across study delivery, site operations, and monitoring roles
Drive site engagement through a clearly differentiated Amgen site experience
Oversee country-level financial and operational management
Lead country governance and risk management
Ensure regulatory compliance, inspection readiness, and continuous improvement

What we offer

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
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible

Fulltime

Us Country Head, Global Site & Study Operations Senior Director

Provide strategic and operational leadership for all study and site execution wi...

Location

United States

Salary:

228624.00 - 265674.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree & 5 years of clinical execution experience or equivalent
Master's degree & 9 years of clinical execution experience or equivalent
Bachelor's degree & 11 years of clinical execution experience or equivalent
In addition to meeting at least one of the above requirements, you must have a minimum of 5 years' experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources.

Job Responsibility

Provide strategic and operational leadership for all study and site execution within the assigned country or hub-and-spoke geography, ensuring delivery of the clinical portfolio in alignment with global study strategies, regulatory requirements, and Amgen quality standards
Accountable for end-to-end study, site, and site engagement execution across the assigned country or hub-and-spoke geography, delivering start-up, enrolment, retention, data quality, and patient safety outcomes in compliance with local regulations and global strategies
Provide strategic leadership for country commitments, acting as a key advisor on study feasibility, placement, and site selection, aligned to global portfolio priorities and regional strengths
Lead, line-manage, and develop the Country/Hub team, ensuring clear direction, strong performance, capability development, and succession planning to deliver portfolio and organizational objectives
Ensure adequate and timely resourcing across study delivery, site operations, and monitoring roles, working closely with global partners to match capacity and capability to portfolio demand
Drive site engagement through a clearly differentiated Amgen site experience strengthening investigator and site relationships through strong leadership, compliance, innovation, and collaboration with global study teams
Oversee country-level financial and operational management, including budgets, forecasting, vendor oversight, and efficient allocation of resources to ensure accountability and value delivery
Lead country governance and risk management, including chairing the Country Management Team (CMT),representing the country in senior governance forums, and managing risks, issues, and escalation to protect quality and delivery
Ensure regulatory compliance, inspection readiness, and continuous improvement, promoting best-practice sharing, audit readiness, and adherence to ICH-GCP, SOPs, and local regulatory requirements.

What we offer

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 and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible

Brazil Country Head, Global Site & Study Operations Associate Director

Provide strategic and operational leadership for all study and site execution wi...

Location

Brazil , São Paulo

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 3 years of clinical execution experience
Master’s degree and 7 years of clinical execution experience
Bachelor’s degree and 9 years of clinical execution experience
At least 3 years’ experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources
+8 years’ work experience in life sciences or medically related field, including 6 years of biopharmaceutical clinical research experience
Experience at, or oversight of, clinical research vendors (CRO’s, central labs, imaging vendors, etc.)
Significant experience managing clinical operations across relevant geography / region, including strong understanding of local regulatory requirements around global clinical trials
Advanced English proficiency

Job Responsibility

Provide strategic and operational leadership for all study and site execution within the assigned country or hub-and-spoke geography
Accountable for end-to-end study, site, and site engagement execution across the assigned country or hub-and-spoke geography
Provide strategic leadership for country commitments, acting as a key advisor on study feasibility, placement, and site selection
Lead, line-manage, and develop the Country/Hub team
Ensure adequate and timely resourcing across study delivery, site operations, and monitoring roles
Drive site engagement through a clearly differentiated Amgen site experience
Oversee country-level financial and operational management, including budgets, forecasting, vendor oversight
Lead country governance and risk management, including chairing the Country Management Team (CMT)
Ensure regulatory compliance, inspection readiness, and continuous improvement

What we offer

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 and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible

Fulltime

Executive Director, Global Clinical Operations

We are seeking an Executive Director, Global Clinical Operations, (GCO), who wil...

Location

United States

Salary:

285000.00 - 320000.00 USD / Year

Apogee Therapeutics

Expiration Date

Until further notice

Requirements

BA/BS in life sciences or equivalent
Minimum 20 years of clinical research experience, including at least 5 years leading global projects from inception to completion
Minimum of 7 years line management experience
Minimum of 3 years’ experience in Biotech industry strongly preferred
Significant knowledge of pharmaceutical industry, drug development and regulatory processes
Experience developing all clinical trial plans, including site management, risk assessment and mitigation strategies, recruitment and retention plans, etc.
Leader with growth mindset, willing to learn from others, committed to mentoring others and dedicated to promoting psychological safety
Ability to build and lead high-functioning teams, both within clinical operations and cross-functionally
Excellent communication skills with ability to develop strong relationships and present to a variety of stakeholders and tailor message accordingly
Strong project management skills with high sense of urgency, ability to collaborate and influence effectively cross-functionally

Job Responsibility

Manage and plan CTO resourcing for assigned programs
Lead, build and mentor CTO team supporting assigned program(s)
Serve as a member on Clinical Operations Leadership Team (COLT)
Create and support implementation of Clinical Operations processes, platforms and/or systems
Clinical operations representative on global development teams (GDT) and/or oversees direct reports serving on GDTs
Clinical operations representative on Program Teams (PT)
Lead problem solving and facilitate teams to identify clinical operations issues and propose solutions
Identify critical path items and evaluate variances to propose and oversee the implementation of proactive contingency plans
Compile, assess, and communicate risks and optionality to support informed decision making for operational strategy
Strong collaboration and partnership with cross functional colleagues globally

What we offer

Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
Three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
Commitment to growing you professionally and providing access to resources to further your development
Apogee offers regular all team, in-person meetings to build relationships and problem solve

Fulltime

Executive Director, Data & Technology Site & Study Startup Support

The Executive Director, D&T Site & Study Startup Support serves as the senior te...

Location

United States

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

15+ years of experience in clinical operations technology, Site & Study Startup processes, feasibility, regulatory workflows, or related domains
Experience implementing enterprise clinical systems and managing cross‑functional integrations
Proven ability leading global, matrixed technology or operational teams
Bachelor’s degree in Life Sciences, Engineering, Business, or related discipline required
Master’s degree or equivalent experience preferred
Deep knowledge of site and study startup processes (feasibility, submissions, activation, regulatory workflows)
Strong understanding of clinical operational systems and data flows
Expertise delivering technology solutions in regulated clinical research environments
Executive‑level communication, influence, and cross‑functional leadership
Ability to translate operational challenges into system and data improvements

Job Responsibility

Serve as the primary D&T executive partner for the global Site & Study Startup function, ensuring alignment to operational processes and startup lifecycle needs
Drive system enhancements that improve startup predictability, data capture, cycle times, and risk identification
Use innovative technology to improve effectiveness and efficiency of the business
Partner with business leaders to ensure systems availability and support for feasibility modeling, country and site selection, document collection and workflows, ICF customization, EC/RA/MoH submissions, SIV scheduling and activation readiness
Provide technology, analytical models, and data tools for feasibility assessments
Ensure real‑time access to feasibility insights, performance history, and site data across data platforms
Oversee integrations between Site & Study Startup systems and broader D&T ecosystem systems
Coordinate with regulatory and compliance technology partners to ensure consistent data flows
Ensure end‑to‑end system readiness and integration for regulatory document management, site regulatory package preparation, greenlight/activation processes, system setup and training workflows
Build and scale reporting capabilities that measure startup progress, activation risks, feasibility metrics, and regulatory timelines

What we offer

Health, Vision & Dental Insurance
Tuition Reimbursement
Vacation/Holiday/Sick Time
Flexible Spending & Health Savings Accounts
Work/Life Balance
401(k) with Company match
Pet Insurance
Opportunity to work on innovative projects at the forefront of the industry
Collaborative and inclusive work environment that values your expertise
Professional advancement and development opportunities

Director - Site Validation

At Amgen, our mission is to serve patients. At our Dun Laoghaire (ADL) site, we ...

Location

Ireland , Dun Laoghaire

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 4 years of directly relevant experience
Master’s degree and 8 years of directly related experience
Bachelor’s degree in Engineering, Life Sciences, or associated discipline and 10 years of directly related experience
Within experience must have 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, and programs or directing the allocation of resources
Extensive experience in validation within a sterile/aseptic manufacturing environment (fill-finish highly preferred)
Strong expertise in: Aseptic process simulation (media fills)
Cleaning validation
Equipment qualification and lifecycle management
Commissioning and qualification (CQV) for capital projects
Proven experience supporting large-scale capital project delivery and facility start-ups

Job Responsibility

Strategic leadership for all site validation activities, ensuring alignment with Amgen global standards, regulatory requirements, and site objectives
Leading and developing a high-performing Validation organisation, setting clear expectations and fostering a culture of quality, compliance, accountability, and continuous improvement
Development of the organisation includes robust succession planning as well as a focus on how the function will support 24/7 operations e.g. via a new validation shift team
Owning all validation lifecycle activities including: Aseptic Process Simulations (media fills) strategy and execution
Airflow Visualisation Studies (AVS) and HVAC requalification programs
Sterilisation validation (VHP, autoclaves, SIP/CIP, lyophilisation)
Cleaning validation programs
Equipment validation
Facilities and Utilities
Effective continued process verification and lifecycle validation, including periodic review, requalification and data-driven performance monitoring programs

What we offer

Vast opportunities to learn and move up and across our global organisation
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan — including health, finance, and wealth benefits
Flexible work models, including remote and hybrid work arrangements, where possible

Fulltime

Local Study Associate Director

ICON plc is a world-leading healthcare intelligence and clinical research organi...

Location

United States

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor degree in related discipline, preferably in life science, or equivalent qualification
Five years of US focused clinical trial management experience, including budget oversight
Good knowledge of international guidelines ICH- GCP as well as relevant local regulations
Excellent project management skill
Excellent team building and interpersonal skills
Excellent organisational skills
Excellent verbal and written communication skills
Excellent ability to prioritize and handle multiple tasks
Excellent attention to details
Excellent knowledge of spoken and written English

Job Responsibility

Has the overall responsibility for the study commitments within the country and for timely delivery of data to required quality
Leads and optimizes the performance of the Local Study Team(s) at country level ensuring compliance with Procedural Documents, ICH-GCP and local regulations
Ensures, as required, that clinical and operational feasibility assessment of potential studies is performed to the highest quality
Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits to evaluate suitability and quality risks
Ensures timely submission of application/documents to EC/IRB at start up and for the duration of the study
Works together with Regulatory Affairs to ensure timely delivery of application/documents for submissions to Regulatory Authority for the duration of the study, and in line with local regulations
Ensures timely preparation of country financial Study Management Agreement (fSMA) and maintains accurate study budget in AZ clinical studies financial system by regular checks of the system and financial reports (as agreed with Director, SMM/ Director, Country Head
Ensures timely preparation of local Master CSA (including site budget) and amendments as needed
Ensures timely preparation of country level Master Informed Consent Form (MICF) and subsequent site level ICFs, as required, including any relevant translations, and in line with relevant SOPs and local regulations
Ensures all country and site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness, prior to setting sites ready to enrol, and in line with SOPs

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

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Director Global Site & Study Operations

Job Description

Job Responsibility

Requirements

What we offer

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