Executive Director, Study Start-Up Job at Amgen (Thousand Oaks)

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

Director Study Start-Up

In this vital role you will ensure world-class study start-up planning and execu...

Location

United Kingdom , Uxbridge; London; Cambridge

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Degree educated
Clinical trial execution experience
Previous experience leading and managing global teams across multiple clinical functions
Project management experience
Previous management experience of direct reports and/or global teams across multiple geographies
Experience working with or overseeing clinical research vendors (e.g., CROs, central labs, imaging)

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, building a high-performing, engaged, and future-ready team
Drive continuous improvement through leadership of the SSU Hub, promoting innovation, consistency, and best-practice ways of working
Oversee SSU operating model performance, proactively identifying risks and implementing improvements to optimise delivery outcomes
Ensure strong SSU management capability through targeted development of skills, processes, systems, and technology expertise
Lead SSU manager resource planning and forecasting to ensure optimal capacity and effective portfolio delivery
Foster a culture of empowerment, collaboration, and open communication that encourages learning and challenges the status quo

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 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

New

Senior Site Director, Clinical Operations

Proclinical is seeking a Site Director, Clinical Operations to be responsible fo...

Location

Belgium , Brussels

Salary:

Not provided

Proclinical

Expiration Date

Until further notice

Requirements

Bachelor's Degree in a Life Science discipline required
Bachelor's Degree in Nursing or RN a plus
Proven working years of direct site monitoring experience required
Detailed understanding of all aspects of clinical site monitoring as well as understanding of overall drug development required
Thorough understanding of EMA, ICH and GCP guidelines and applicable local regulations
Excellent critical thinking skills and ability to understand complex patient histories, medical terminology and treatment landscapes
Ability to interpret study level metrics data and proactively identify and mitigate risks through study lifecycle
Detail-oriented, organized and committed to quality and consistency
Results-driven and capable of managing competing high-priority assignments with a proven track record of achieving deliverables within specified timelines
Ability to contribute to the culture of process improvement with a focus on streamlining processes adding value to the company business and needs

Job Responsibility

Responsible for the successful start-up, monitoring and execution of Phase I-IV studies at assigned clinical sites
Perform clinical site management and monitoring activities in compliance with principles of ICH-GCP guidelines, SOPs, local laws and regulations, study protocol(s), applicable study plans and working guidelines
Serve as primary point of contact for clinical sites through all phases from start-up to close-out of clinical studies
Arrange for monitoring availability and ensure data entry timelines are maintained at assigned sites
Perform required monitoring, including required source data verification, and ensure site activities are conducted in established timelines
Develop and cultivate strong site relationships and ensure continuity of site relationships
Communicate with investigators and site staff on issues related to protocol conduct, recruitment, protocol deviations, inspection readiness and overall site performance
Identify, assess, escalate and resolve site performance or quality issues in a timely manner
Complete feasibility and site identification activities for new clinical studies
Conduct start-up and maintenance activities for designated sites including preparation and collection of essential documents required for regulatory and IRB/EC submission (initial and amendments)

Associate Director, Clinical Operations

We are seeking an Associate Director, Clinical Operations who will be accountabl...

Location

United States

Salary:

180000.00 - 195000.00 USD / Year

Apogee Therapeutics

Expiration Date

Until further notice

Requirements

BA/BS in life sciences or equivalent
8+ years of clinical research experience, including at least 3 years leading global projects from inception to completion
2+ 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, trial budgets and program-level budgets
Leader with growth mindset, willing to learn from others, committed to mentoring others and dedicated to promoting psychological safety
Strong communication skills with ability to present to a variety of stakeholders and tailor message accordingly
Strong project management skills with ability to collaborate effectively cross-functionally and hold team and CRO members accountable to tight timelines and budgets
High sense of urgency and ability to proactively identify critical path items and develop contingency plans to mitigate risk to budget, quality, and/or timelines
Work comfortably in a fast-paced, dynamic work environment and embrace change

Job Responsibility

Accountable for overall management of multiple clinical trials
Serves as the central point of contact and contributes expertise for clinical trial execution on assigned protocols
Works cross-functionally to establish and ensure clinical program timelines and goals are met and risks are appropriately escalated to Clinical Management. Ensures accurate tracking and reporting (dashboard) of study metrics and progress of study through completion
Leads the Clinical Study Team (CST) and may participate in other cross functional program team meetings
Ensures trial adherence to ICH/GCP/Federal and local regulations and company specific SOPs
Responsible for preparing and/or presenting to executive management as delegated
Develops, reviews and/or consults on clinical trial documents, such as study specific plans, informed consent, clinical protocols, Investigator Brochure, CSRs, yearly updates to the regulatory authorities and status updates
May be responsible for participating and presenting at Investigator Meetings, SIVs and other program meetings
Responsible for study level clinical operations budget forecasting, accrual management and quarterly review ensuring tight control between study forecasts and actuals
In conjunction with key stakeholders, oversee and manage the execution and filing of site clinical trial agreements, review of fair market value, CRO and vendor contracts, NDAs, etc

What we offer

A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless
Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly
Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
We provide competitive time off, including 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

Medical Director, Clinical Development – Dermatology

We are seeking a Medical Director to support clinical execution and medical moni...

Location

United States

Salary:

270000.00 - 310000.00 USD / Year

Apogee Therapeutics

Expiration Date

Until further notice

Requirements

MD is required
Dermatologist strongly preferred
Experience in clinical development and/or study design and execution within the Immunology & Inflammation therapeutic areas, ideally dermatology, allergy or rheumatology
2+ years’ pharma/biotech clinical development or medical affairs with study execution experience preferred
Experience working on phase 2 and 3 clinical studies strongly preferred

Job Responsibility

Serve as a primary Sponsor medical representative for assigned clinical trial
Contribute to protocol development, study documents, operational plans, and other relevant documents for individual studies
Support all the start-up activities related to the assigned Dermatology clinical study including investigator training, vendor discussions, cross-functional team reviews
Oversee day-to-day clinical and medical execution of studies including direct medical review of eligibility, safety events, and clinical data
Work closely with cross-functional colleagues to ensure timely and flawless execution of clinical plan and study milestones
Partner with clinical operations on site selection, recruitment, site relationship management and CRO management
Partner with medical affairs to build and maintain strong relationships with PIs

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

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

Executive Director, Study Start-Up

Amgen

Location:
United States , Thousand Oaks

Category:
Research and Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
February 06, 2026

Looking for more opportunities? Search for other job offers that match your skills and interests.

Similar Jobs for Executive Director, Study Start-Up

Associate Director Study Start-up

Associate Director Study Start-Up

Director Study Start-Up

Director study start-up

Senior Site Director, Clinical Operations

Associate Director, Clinical Operations

Medical Director, Clinical Development – Dermatology

Director Global Site & Study Operations

Executive Director, Study Start-Up

Amgen

Location:United States , Thousand Oaks

Category:Research and Development

Contract Type:Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:February 06, 2026

Looking for more opportunities? Search for other job offers that match your skills and interests.

Similar Jobs for Executive Director, Study Start-Up

Associate Director Study Start-up

Associate Director Study Start-Up

Director Study Start-Up

Director study start-up

Senior Site Director, Clinical Operations

Associate Director, Clinical Operations

Medical Director, Clinical Development – Dermatology

Director Global Site & Study Operations

Location:
United States , Thousand Oaks

Category:
Research and Development

Contract Type:
Not provided

Job Posted:
February 06, 2026