Associate Director Study Start-Up Job at Amgen (Cambridge)

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, 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

Senior Director, Head of Argentina Clinical Data Sciences

As part of the Clinical Data Sciences (CDS) group, an integral delivery unit wit...

Location

Argentina , Buenos Aires

Salary:

Not provided

Pfizer

Expiration Date

Until further notice

Requirements

University or college degree in life science, computer science, pharmacy, nursing, or equivalent relevant degree. Advanced degree preferred
Ideally 20 or more years’ experience in drug development with at least 10 years in Clinical Data Management
At least 10 years' line management or global project team leadership experience
Clinical development and business experience in order to have a thorough understanding of regulatory processes at a global level
Recognition in peer community as expert and leader in topic area
Ability to leverage network to establish/maintain contact with scientific community
Exceptional technical and problem solving skills, and ability to evaluate computer systems for Data Management
Excellent understanding of clinical trials methodology, GCP and medical terminology
Experience of interaction with major regulatory authorities (not only in India)
Ability to work under pressure, demonstrating a high level of initiative and flexibility

Job Responsibility

Within CDS, lead a regional team comprised of multiple specialized functions and the local resources supporting and/or leading global trials across multiple TAs
Lead and influence across R&D on behalf of their TA Group or Function as a key component of cross-functional R&D planning
Build a brand-new and/or foster CDS departmental presence that has a strong local culture while being a fully integrated member of the worldwide CDS organization
Develop a departmental roadmap starting with the departmental vision, defined through targeted outcomes, strategic initiatives, and tactical deliverables
Ensure strong partnerships within global CDS, across R&D through collaborations with senior leaders (SVP, VP, ED and SD), senior level stakeholders and with external vendors
Act as a thought leader with the network to drive innovation within the organization and across the industry. Lead the conversation in key industry forums through presentations and publications
Lead clinical and non-clinical cross-functional special projects aimed to evolve CDS and partner functions in line with the Pfizer organization and the changing industry landscape
Set current and future strategy as a core member of the CDS Leadership Team
Span of control of 50 or more people or equivalent in terms of functional areas of accountability
As requested, deputize for the responsibilities of the Global Head of CDS

Fulltime

Associate Director, Regional Clinical Operations

Associate Director, Regional Clinical Operations. ICON plc is a world-leading he...

Location

United States , Atlanta; Houston; Tampa; Dallas

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Minimum Bachelor’s degree with 5-7 years of experience in Clinical Trial Operations in pharmaceutical / biotechnology industry or Clinical Research Organization, or equivalent, including at least 3 years in a role of primary responsibility for clinical trial execution and management
Thorough understanding and experience in global clinical trials in a diverse range of patient populations with preferred experience in both oncology and hematology
Direct management experience and supervisory responsibility
Demonstrated leadership and management skills
Goal oriented, self-starter with proven ability to work independently
Good knowledge and experience working with external specialist vendors
Excellent interpersonal, organizational, problem-solving, and written/verbal communication skills, confidence, and ability to work effectively with a wide variety of medical, research and administrative personnel
Able to proactively identify issues and provide potential solutions for resolution
Ability to manage multiple tasks simultaneously and meet deliverables in accordance with stated timelines and to established quality standards
Proficient in Outlook/Word/Excel/PowerPoint

Job Responsibility

Accountable for oversight of all assigned studies within the country in accordance with the overall development plan and clinical operations plan and under the direction of the global team (Global Clinical Trial Manager), including adherence to quality, timelines and budget
Accountable for planning and executing assigned country study goals and commitments, and as needed, leading, organizing, and participating in regional and/or local meetings and training sessions to implement country-level recruitment plans
Develops, builds and maintains optimal relationships with key institutions within the country (i.e. Site Alliance Sites), working closely with the Medical Science Liaisons, Global Site Management and Central Services, and other departments as indicated according to the Site Engagement Strategy
Drive the identification and inclusion of sites that have access to and can enroll patients who are from groups that have been historically underrepresented in clinical trials (per FDA Guidance for Industry for Improving Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials)
Oversees regional study feasibility, site monitoring performance, quality metrics and all relevant activities for assigned studies
Drives evidence-based site recommendations and selection
Provides support and training for sites to support diverse recruitment and retention, review, assist and optimize site-level diversity plans as needed, check and challenge progress and coordinate and align central efforts across sponsor and CROs
Align local and central initiatives and advise and guide on effective community engagement activities
Conduct co-monitoring and site identification visits, as needed
Collaborates cross-functionally to build and maintain strong relationships and interaction at the country local level (i.e. Medical Science Liaisons, Medical Monitors, Clinical Scientists, etc.) that directly contribute to key study activities and milestones

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

Fulltime

Associate Director Regional Clinical Operations

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

Location

United States , Boston, Philadelphia, PA

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Minimum Bachelor’s degree
5-7 years of experience in Clinical Trial Operations in pharmaceutical / biotechnology industry or Clinical Research Organization, or equivalent
At least 3 years in a role of primary responsibility for clinical trial execution and management
Thorough understanding and experience in global clinical trials in a diverse range of patient populations
Preferred experience in both oncology and hematology
Direct management experience and supervisory responsibility
Demonstrated leadership and management skills
Goal oriented, self-starter with proven ability to work independently
Good knowledge and experience working with external specialist vendors
Excellent interpersonal, organizational, problem-solving, and written/verbal communication skills

Job Responsibility

Accountable for oversight of all assigned studies within the country
Accountable for planning and executing assigned country study goals and commitments
Develops, builds and maintains optimal relationships with key institutions within the country
Drive the identification and inclusion of sites that have access to and can enroll patients from underrepresented groups
Oversees regional study feasibility, site monitoring performance, quality metrics
Provides support and training for sites to support diverse recruitment and retention
Conduct co-monitoring and site identification visits
Collaborates cross-functionally to build and maintain strong relationships
Communicates regularly on country study status and escalates unresolved issues
Collaborates with the Global Study Team to develop and execute risk management plans

What we offer

Competitive salary
Various annual leave entitlements
Range of health insurance offerings
Competitive retirement planning offerings
Global Employee Assistance Programme, LifeWorks
Life assurance
Flexible country-specific optional benefits

Fulltime

New

Sous Chef

Calling all super star Sous Chefs. Are you ready to fast track your career? Our ...

Location

United Kingdom , Horley

Salary:

Not provided

Brunning & Price

Expiration Date

Until further notice

Requirements

Previous experience in catering and hospitality in a restaurant, gastro pub or hotel at junior sous, sous or kitchen manager level is essential
Positive attitude

Job Responsibility

Running the kitchen
Driving the food culture
Keeping team and customers engaged with exciting new dishes

What we offer

Basic up to £33,000 plus tronc (card tips paid into bank)
Management Bonus Scheme 2026, potential earnings up to £1500 per year
Paid overtime
Great cash tips
Free meals on shift, choose from the menu
30% discount for you, your friends and family across B&P and our group including wagamama
NEST pension
Life assurance
Great discounts via Perks on Tap saving you money on everyday purchases and more
Cycle to work scheme

Fulltime

New

SEN Teacher

Are you a qualified Teacher looking for a new opportunity? Do you have experienc...

Location

United Kingdom , Huyton

Salary:

Not provided

Randstad

Expiration Date

April 11, 2026

Requirements

Qualified Teacher Status
SEN Experience
Enhanced DBS (or willingness to apply)

Job Responsibility

Planning and delivering lessons for learners with a variety of SEND
Adapting teaching to meet the individual needs of learners
Using summative and formative assessment to monitor progress
Work collaboratively with Teaching Assistants and other relevant professionals
Follow the school's policy for behaviour management to create a positive learning environment
Report any safeguarding concerns to the DSL

What we offer

Access to a dedicated consultant working to find the right role for you
Competitive rates of weekly pay
CPD opportunities
DBS support (if required)
'Refer a Friend' Scheme with the opportunity to earn £300* in Love2Shop vouchers for every successful referral

!

New

Waiter/waitress

If you're passionate about fresh food, the highest service standards and thrive ...

Location

United Kingdom , Wolverhampton

Salary:

12.71 GBP / Hour

Brunning & Price

Expiration Date

Until further notice

Requirements

Previous experience in hospitality as a waitress/waiter, bar tender, barista or food and beverage assistant ideally in a pub, restaurant, hotel or bar would be helpful but isn't essential
Hands on with a positive attitude
Natural ability to look after people and make them happy
Passionate about food and drink

Job Responsibility

Look after our customers in the best way possible
Help keep a busy shift calm and collected

What we offer

Free meals on shift, choose from the menu
30% discount for you, your friends and family across B&P and our group including wagamama
NEST pension
Great discounts via Perks on Tap
£1,000 referral bonus for introducing new Managers or Chefs to the company
Wagestream - use flexible pay to choose when to get paid
Weekly pay
Free 24-hour confidential legal and information helpline for you and your family
Bespoke wellbeing support offering free counselling for all crew
Discounted gym membership

Fulltime

Associate Director Study Start-Up

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

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

Similar Jobs for Associate Director Study Start-Up