Director Study Start-Up Job at Amgen (Uxbridge)

Director study start-up

Ensure world-class study start-up planning and execution by leading teams, stren...

Location

United States

Salary:

206344.00 - 238674.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Pharma and clinical trial processes and operations expertise
Experience leading and managing global teams
Project management experience
Doctorate degree & 4 years of clinical execution experience or equivalent OR Master’s degree & 8 years of clinical execution experience or equivalent OR Bachelor’s degree & 10 years of clinical execution experience or equivalent
Minimum of 4 years' experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources

Job Responsibility

Lead and inspire the Study Start-Up Management team to deliver high-quality study start-up activities with speed, efficiency, and budget discipline
Provide strategic direction and people leadership to SSU Senior Managers
Drive continuous improvement through leadership of the SSU Hub
Oversee SSU operating model performance
Ensure strong SSU management capability through targeted development of skills, processes, systems, and technology expertise
Lead SSU manager resource planning and forecasting
Foster a culture of empowerment, collaboration, and open communication
Build strong partnerships with global and cross-functional stakeholders

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

Associate Director Study Start-up

Drive world-class study start-up planning and execution across a global portfoli...

Location

United States

Salary:

182145.00 - 212860.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Pharma and clinical trial processes and operations expertise
Experience leading and managing global teams
Project management experience
Minimum of 3 years' experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources
Must meet one of the following education/experience combinations: 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
Associate’s degree and 12 years of clinical execution experience
High school diploma / GED and 14 years of clinical execution experience

Job Responsibility

Lead and manage a team of Study Start-up Managers
Drive end-to-end study start-up planning and execution from global to local
Provide portfolio-level oversight of study start-up performance, resourcing, and delivery metrics
Build team capability through coaching, mentoring, performance management
Partner with functional and hub leaders to strengthen study start-up capabilities
Own and embed study start-up business processes
Foster a collaborative, high-engagement culture
Contribute to the evolution of the Study Start-up Hub model

What we offer

Total Rewards Plan comprising health and welfare plans for staff and eligible dependents
Financial plans with opportunities to save towards retirement or other goals
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

Associate Director Study Start-Up

In this vital role you will lead world-class study start-up planning and executi...

Location

United Kingdom , Cambridge; London; Uxbridge

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Degree educated
Clinical trial execution experience and previous experience leading and managing global teams across multiple clinical functions as well as project management experience
Previous experience in life sciences focusing on clinical trials, including biopharmaceutical clinical research
Previous management experience of direct reports and/or global teams across multiple clinical functions

Job Responsibility

Lead and develop a team of Study Start-up Managers to deliver high-quality, compliant start-up activities across programs and therapeutic areas
Drive end-to-end global and local study start-up planning and execution, meeting timelines, budget, and regulatory (ICH-GCP) requirements
Provide portfolio-level oversight of performance, resourcing, and metrics, proactively identifying risks and recommending solutions
Build team capability through coaching, mentoring, and performance management, embedding best practices and continuous improvement
Partner with functional and hub leaders to strengthen start-up capabilities, processes, and operational readiness
Own and embed study start-up processes and contribute to the evolution of the Study Start-up Hub model, fostering collaboration, innovation, and knowledge sharing

What we offer

Vast opportunities to learn and move up and across our global organization
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

Executive Director, Study Start-Up

In this vital role as Executive Director, Study Start-Up (SSU), you will lead SS...

Location

United States , Thousand Oaks

Salary:

281634.00 - 336501.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 6 years of clinical execution experience
Master’s degree and 10 years of clinical execution experience
Bachelor’s degree and 12 years of clinical execution experience
6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
12+ years’ work experience in life sciences industry, particularly focusing on clinical trial work, including 10+ years of biopharmaceutical clinical research experience obtained at a biotech or pharmaceutical company
Experience engaging and working across clinical trial teams in multiple geographies to deliver global clinical trials
Experience driving and leading organizations through cross-functional change initiatives such as identifying solutions to problems and innovating and change strategies and structure to meet future needs
Experience leading cross-functional / cross-geography / cross-trial teams, ensuring operational excellence and smooth decision-making
ability to escalate and resolve challenges in alignment with global study strategy priorities
Extensive knowledge of the clinical and pharmaceutical drug development process, from early to late-stage development with a deep understanding of relevant therapeutic areas to meet the highest scientific and regulatory standards

Job Responsibility

Shape the long-term vision and strategy of the SSU Hub, ensuring alignment with CPSO, GDO, and enterprise priorities
Integrate and harmonize strategies from the six sub-functions into a single global capability strategy, balancing standardization with local/regional adaptability
Act as the global escalation point for study start-up risks and issues, ensuring timely resolution and portfolio-level visibility
Embed within the industry - bringing outside ways of working and representing Amgen back into the industry
Build and develop a high-performing global SSU leadership team (Directors, Sr Managers) creating a culture of accountability, innovation and operational excellence
Lead, and mentor the global SSU Hub leadership team, ensuring robust succession planning, talent development, and organizational effectiveness
Drive consistent performance management, alignment, and calibration across sub-functions to ensure equitable resourcing and delivery
Embed a center of excellence mindset, encouraging knowledge-sharing and best practice adoption globally
Oversee start-up planning and execution across all new studies globally, ensuring timelines and quality standards are consistently achieved
Partner with Clinical Program Strategy and Operations TA Heads to ensure seamless integration of start-up into program execution

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

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

Director Global Site & Study Operations

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

Location

United Kingdom , Uxbridge; London; Cambridge

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

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

Director of Research Operations

The Director of Research Operations, working with the Chief of Medical Research,...

Location

United States , Hollywood

Salary:

Not provided

Memorial Healthcare System

Expiration Date

Until further notice

Requirements

Bachelors (Required)
Minimum of seven (7) years of experience in clinical research administration, including leadership of research operations
Requires critical thinking skills, decisive judgment, and the ability to work with minimal supervision
Must be able to work in a stressful environment and take appropriate action
Extensive clinical and health services research and operations experience, affording the ability to advise, implement, oversee, and strategize to optimize research funding and productivity
Strong knowledge of FDA, ICH-GCP, OHRP, CMS billing compliance, and federal grant regulations
Strong leadership, communication, and change-management skills
Demonstrated experience overseeing study start-up, research contracting, coverage analysis, budgeting, and finance
Experience with research billing compliance and clinical trial financial workflows
Experience developing process improvements, KPIs, and productivity/workload systems

Job Responsibility

Serves as consultant to all levels of management to provide decision support for initiatives, policies, and procedures
Functions in a supervisory capacity by staffing, hiring, orienting, performance management and administering disciplinary actions for employees
Takes an active role in ensuring positive Employee Engagement within the department
Performs special projects and duties as assigned, including necessary research, forecasting, and conflict resolution
Directs sponsor and departmental budget preparation and financial planning processes including budget review for compliance and opportunities
developing protocol specific budgets
and tracking protocol related revenues and expenses by sponsors
Directs and performs statistical, cost, and financial analysis of research data extracted from various internal sources
Prepares reports based on findings, including healthcare costs, grants, provider contracts, debt capacity, and revenue and profitability

Fulltime

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Director Study Start-Up

Job Description

Job Responsibility

Requirements

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