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

Global Production Director

The Global Production Director is tasked with overseeing and advancing the plann...

Location

Spain , Madrid

Salary:

Not provided

Fever

Expiration Date

Until further notice

Requirements

8–10 years in live entertainment production with a focus on creative involvement
Strong leadership, creative evaluation, and project management skills
proven ability to manage multiple projects concurrently
Bachelor’s degree in Production, Fine Arts, Business, or a related field (or equivalent experience)
Familiarity with global live entertainment markets, regional nuances, and emerging industry trends
Availability to travel internationally as required

Job Responsibility

Develop comprehensive plans for permanent attraction projects by coordinating cross-functional teams to align on goals, budgets, and timelines
Conduct feasibility studies for potential expansion opportunities, assessing resource needs, estimated costs, and operational impacts
Drive the creation of a phased expansion roadmap, aligning with corporate growth strategies
Lead and manage production teams to deliver all projects within the agreed scope, ensuring adherence to schedules and budgets
Establish and implement standardized production processes to maintain consistency and quality across various project types and across geographies
Act as a key decision-maker for high-stakes issues related to technical requirements, resource allocation, and vendor selection
Assess current work methods / production workflows / local processes and challenge proposed approaches and provide creative alternatives, suggestions to improve ongoing projects
Build, train, and manage production teams specializing in permanent attractions
Support the professional growth of team members through ongoing training, mentoring, and performance feedback
Ensure local producers have the necessary tools, resources, and guidance

What we offer

40% discount on all Fever events and experiences
Work in the centre of the city with opportunities to travel
Responsibility from day one and professional and personal growth and the opportunity to have a real impact in a high-growth global category leader
Health and dental Insurance
Wellhub membership
Flexible remuneration plan
Great work environment with a young, international team of talented people to work with

Fulltime

Global Production Director

The Global Production Director is tasked with overseeing and advancing the plann...

Location

France , Paris

Salary:

Not provided

Fever

Expiration Date

Until further notice

Requirements

8–10 years in live entertainment production with a focus on creative involvement
Strong leadership, creative evaluation, and project management skills
proven ability to manage multiple projects concurrently
Bachelor’s degree in Production, Fine Arts, Business, or a related field (or equivalent experience)
Familiarity with global live entertainment markets, regional nuances, and emerging industry trends
Availability to travel internationally as required

Job Responsibility

Develop comprehensive plans for permanent attraction projects by coordinating cross-functional teams to align on goals, budgets, and timelines
Conduct feasibility studies for potential expansion opportunities, assessing resource needs, estimated costs, and operational impacts
Lead and manage production teams to deliver all projects within the agreed scope, ensuring adherence to schedules and budgets
Establish and implement standardized production processes to maintain consistency and quality across various project types and across geographies
Build, train, and manage production teams specializing in permanent attractions
Oversee the standardisation of venue feasibility assessments, ensuring locations meet both practical and convenience requirements
Standardize playbook deployment across all sites and partnerships
Oversee vendor and supplier relationships to ensure timely delivery and quality of materials and equipment
Establish quality control measures and safety standards for all productions, ensuring regulatory compliance and risk mitigation
Develop guiding principles and value optimisation for production budgets, and ensure consistency and clarity throughout local implementation

What we offer

40% discount on all Fever events and experiences
Work in the centre of the city with opportunities to travel
Responsibility from day one and professional and personal growth and the opportunity to have a real impact in a high-growth global category leader
Health and dental Insurance
Wellhub membership
Flexible remuneration plan
Great work environment with a young, international team of talented people to work with

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.

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

Senior Clinical Research Associate II - FSP

As a Clinical Research Associate (CRA) at Parexel, you act as an integral part t...

Location

Turkey

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations
Monitoring Experience: Minimum 5 years relevant experience in clinical research site monitoring (preferably 3 years in Oncology)
Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases
Global clinical trial experience
Must be fluent in English and in the native language(s) of the country they will work in
Significant travel (60-80%) within area is required. May require some international travel and some weekend travel
Valid driver’s license and passport required
Demonstrated knowledge of clinical research and development processes and ability to gain command of process details
Demonstrated knowledge of global and local regulatory requirements
Demonstrated understanding of key operational elements of clinical research (e.g., monitoring, data acquisition and cleaning, reporting, etc.)

Job Responsibility

Oversight of Monitoring Responsibilities and Study Conduct
Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and client standards to achieve project goals, timelines and quality
Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met
During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery
Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites
Partner with SCP to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients
provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks
Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators. Partner with SCP and the study team to define and support recruitment initiatives at site level
Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies
Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution

What we offer

Flexible work arrangements
Career growth and development
Supportive and inclusive environment
Diverse therapeutic areas and project exposure
Advanced Technology

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

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

Associate Director, Monitoring Oversight Management

We are seeking an Associator Director, Monitoring Oversight Management, to manag...

Location

United States

Salary:

180000.00 - 205000.00 USD / Year

Apogee Therapeutics

Expiration Date

Until further notice

Requirements

Bachelor's degree in a scientific or healthcare-related field
Minimum of 8-10 years of experience as a CRA or related role within the pharmaceutical or biotechnology industry
Minimum 5 years of experience leading a team of CRAs
Recent experience working on respiratory, dermatology and / or gastrointestinal clinical trials preferred
Experience working in Phase I – III clinical trials
Recent experience working on trials utilizing risk-based monitoring models
Strong knowledge of International Council for Harmonization (ICH) guidelines, Good Clinical Practice (GCP) and FDA regulations
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and Smartsheet
Experience with EDC systems, electronic trial master files (eTMFs) and other clinical trial databases and systems
Strong understanding of clinical trial processes and study conduct

Job Responsibility

Manage Apogee’s Oversight CRAs who will oversee the performance of CRO monitoring and site management related activities for Apogee sponsored clinical trials
Support contract Oversight CRAs globally
Serve as Apogee’s primary liaison with the in-house Oversight CRAs and Lead CRAs
Contribute to building a culture of team, site and patient centricity
Contribute to monitoring related process development, continuous evaluation of monitoring related resourcing, and the development and implementation of risk-based monitoring strategies
Leadership of Oversight CRAs globally driving the team to ensure study deliverables are met with efficiency and quality
Responsible for hiring in-house Oversight CRAs
Assist with creation, review and revision of departmental SOPs and policies
Lead, conduct, and document regular meetings with Oversight CRA team and with individual CRAs
Assist with creation and delivery of department initiatives, improvement plans and/or training

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

Amgen

Location:
United Kingdom , Cambridge ▼
London
Uxbridge

Category:
-

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
February 18, 2026

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Location:United Kingdom , Cambridge ▼LondonUxbridge

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Job Description:

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