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

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, Global Supply Chain

The Associate Director, Global Supply Chain reports to the Senior Director, Glob...

Location

United States , Waltham, MA or San Diego, CA

Salary:

160000.00 - 200000.00 USD / Year

Kailera Therapeutics

Expiration Date

Until further notice

Requirements

Bachelor’s degree and 10+ years of relevant biopharmaceutical industry experience or advanced degree with 5+ years of experience
6+ years of experience in clinical supply management
Knowledgeable in the implementation and workings of IRT systems
Ability to create a collaborative environment and manage multiple project activities
Strong computer skills including MS Office
Hands-on, roll-up-your-sleeves, collaborative approach with high sense of urgency and drive for results
Ability to think outside of the box and challenge the status quo
Desire to work in a fast-paced, innovative environment
Ability to travel up to 20%

Job Responsibility

Assist with investigational drug product supply and logistics activities, including, but not limited to, demand forecasting and supply planning, IRT start-up and maintenance, label generation and approval, packaging and labeling operations, release and distribution, expiry extension, returns, reconciliation, destruction, cold chain management, and inventory management
Maintaining oversight in monitoring inventory levels throughout the life of a clinical trial
Support with oversight of packaging and labeling/distribution vendors, including relationship management
Coordinate the preparation of clinical trial pharmacy manuals, packaging methods, batch records, drug labels, shipping documents, destruction certification, and coordinating the origination, proofing, and translation of clinical study labels and generation
Proactively identify potential issues, notify supervisor in a timely manner, and develop mitigating actions
Interpret clinical synopses and protocols to create clinical IMP demand forecasts
Attend clinical study and cross functional meetings as needed
Assist the global supply chain lead in overseeing the execution of multiple clinical trials and proactively identify potential supply chain issues and recommending solutions to global supply chain lead
Lead clinical study close-out activities, including returned goods reconciliation and inventory destruction
Assist with drug supply delivery through coordination of CMC efforts (including, but not limited to, CMC, Supply Chain, Legal, Procurement, Commercial, Regulatory, Clinical Development, and Clinical Operations)

What we offer

comprehensive health coverage
flexible time off
paid holidays
year-end shutdown
monthly wellness stipend
generous 401(k) match
tuition reimbursement
commuter benefits
disability and life insurance
annual bonus opportunities

Fulltime

Associate Director, Global Supply Chain

The Associate Director, Global Supply Chain reports to the Senior Director, Glob...

Location

United States , Waltham

Salary:

160000.00 - 200000.00 USD / Year

Kailera Therapeutics

Expiration Date

Until further notice

Requirements

Bachelor’s degree and 10+ years of relevant biopharmaceutical industry experience or advanced degree with 5+ years of experience
6+ years of experience in clinical supply management
Knowledgeable in the implementation and workings of IRT systems
Ability to create a collaborative environment and manage multiple project activities
Strong computer skills including MS Office
Hands-on, roll-up-your-sleeves, collaborative approach with high sense of urgency and drive for results
Ability to think outside of the box and challenge the status quo
Desire to work in a fast-paced, innovative environment
Ability to travel up to 20%

Job Responsibility

Assist with investigational drug product supply and logistics activities, including, but not limited to, demand forecasting and supply planning, IRT start-up and maintenance, label generation and approval, packaging and labeling operations, release and distribution, expiry extension, returns, reconciliation, destruction, cold chain management, and inventory management
Maintaining oversight in monitoring inventory levels throughout the life of a clinical trial
Support with oversight of packaging and labeling/distribution vendors, including relationship management
Coordinate the preparation of clinical trial pharmacy manuals, packaging methods, batch records, drug labels, shipping documents, destruction certification, and coordinating the origination, proofing, and translation of clinical study labels and generation
Proactively identify potential issues, notify supervisor in a timely manner, and develop mitigating actions
Interpret clinical synopses and protocols to create clinical IMP demand forecasts
Attend clinical study and cross functional meetings as needed
Assist the global supply chain lead in overseeing the execution of multiple clinical trials and proactively identify potential supply chain issues and recommending solutions to global supply chain lead
Lead clinical study close-out activities, including returned goods reconciliation and inventory destruction
Assist with drug supply delivery through coordination of CMC efforts (including, but not limited to, CMC, Supply Chain, Legal, Procurement, Commercial, Regulatory, Clinical Development, and Clinical Operations)

What we offer

comprehensive health coverage
flexible time off
paid holidays
year-end shutdown
monthly wellness stipend
generous 401(k) match
tuition reimbursement
commuter benefits
disability and life insurance
annual bonus opportunities

Fulltime

New

Territory Manager

2020 Companies is hiring Territory Managers who are experts in brand advocacy an...

Location

United States , Seattle

Salary:

25.00 USD / Hour

2020 Companies, Inc

Expiration Date

Until further notice

Requirements

High school diploma or equivalent experience required
Six (6) months prior sales, promotion, retail, or marketing experience
Demonstrated knowledge of products and services
Excellent communications, presentation, interpersonal and problem-solving skills
Impeccable integrity and commitment to customer satisfaction
Ability to lift and carry up to 15 lbs. at a time
Ability to multi-task in a fast-paced, team environment
Ability to maintain customer confidentiality
Reliable transportation within assigned territory

Job Responsibility

Partner with the client to train and advocate client products at the retailer
Drive merchant awareness within your assigned territory
Maintain professional interaction with both merchants and fellow employees
Attempt to place point of purchase signage on exterior and/or interior of business
Advise merchants by providing information on products
Audit and record competitive products, promotions, merchandising, displays and merchant feedback
Travel to major markets and events for iconic launches to promote products
Contribute to team effort by assisting in launch-related activities, as needed
Responsible for accurately tracking and communicating all activity to Retail Operations
Ensure feedback reporting is submitted in timely manner

What we offer

Next-Day Pay On-Demand with DailyPay
Monthly Bonus Opportunity
Monday - Friday Schedule
Paid Training
Paid Travel Time
Mileage Reimbursed
Mobile Device Provided
Apparel Provided
Health/Dental/Vision Insurance
401K Program

Fulltime

New

Senior Regulatory Affairs Associate - Spain Local Regulatory Responsible Person

As part of Parexel Consulting, you will play a vital role in helping biopharmace...

Location

Spain , Madrid

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

University degree in a life science discipline
Minimum 5 years' experience in Spanish Regulatory Affairs, with strong understanding of Spanish and EU regulatory requirements
Proven experience with multiple submission types: CP, MRP, DCP, and National procedures
Comprehensive lifecycle management expertise for Spanish submissions
Experience with AEMPS submission processes and requirements
Competence in labelling management (updates, mock-up review, and print release processes)
Medical device knowledge advantageous, but not essential
Familiarity with systems such as Veeva Vault
Excellent organizational, time management, and interpersonal skills in a global environment
Proven ability to work effectively both independently and in teams

Job Responsibility

Provide local inputs to develop and execute innovative regulatory strategies for new product registrations and lifecycle management activities
Ensure strict compliance with local regulations and actively participate in policy activities with industry groups and trade associations
Act as RA representative in audits/inspections, ensuring readiness and timely CAPA closure
Monitor regulatory landscape changes and communicate requirements to Global Regulatory Affairs (GRA) and local teams
Serve as primary interface with AEMPS (Agencia Española de Medicamentos y Productos Sanitarios), industry groups, and trade associations
Lead in-country regulatory processes for licenses, partner regulatory licenses, and market access collaborations
Prepare and coordinate local-specific documentation (e.g., Module 1) to meet national submission requirements
Monitor status of submitted regulatory activities and ensure timely completion
Manage comprehensive lifecycle activities including variations, renewals, PSURs, and PIP submissions
Ensure timely submission of renewals and mandated post-approval applications

What we offer

Flexible work arrangements
Opportunities for career growth
Supportive and inclusive environment
Diverse and global client exposure
Learn from experts

New

Energy sales specialist

Launch Your Career in Energy Sales with Reliant! 2020 Companies is seeking an en...

Location

United States , Missouri City

Salary:

16.00 USD / Hour

2020 Companies, Inc

Expiration Date

Until further notice

Requirements

High school diploma or equivalent required
Six (6) months prior sales, retail, telecom or marketing experience
Demonstrated knowledge of products and services
Excellent communications, presentation, interpersonal and problem-solving skills
Impeccable integrity and commitment to customer satisfaction
Ability to multi-task in a fast-paced, team environment
Must be available to work evenings, weekends and holidays as needed
Ability to maintain customer confidentiality
Strong experience in retail/event sales or event marketing
Strong communication, interpersonal, and problem-solving skills

Job Responsibility

Promote Reliant electricity plans to consumers
Help customers lower energy costs in your community
Learn to identify needs and handle objections
Build strong relationships with customers and teammates
Work together to hit goals and celebrate wins
Sell products and services in a retail store, kiosk, and/or event environments
Maintain professional interaction with both customers and fellow employees
Meet or exceed personal sales goals on a monthly basis
Courteously welcome customers and offer assistance
Direct customers by escorting them to displays

What we offer

Earn $1,000-$1,350/week on average with base pay & uncapped commission combined
Commission-based pay, with a $16.00/hr guarantee. Next-day pay via Daily Pay
Career advancement through internal promotions
Health benefits, paid time off, and 401k with company match

Fulltime

New

Director, Mergers and Acquisitions

The Director of Mergers & Acquisitions / Acquisition Integration (M&A/AI) will l...

Location

United States , Irving

Salary:

Not provided

7-Eleven, Inc

Expiration Date

Until further notice

Requirements

Advanced skills in Microsoft Office Suite (Excel, PowerPoint, Word)
experience with Smartsheets, Salesforce, GIS tools (e.g., ArcGIS), and trade area analysis platforms (e.g., Kalibrate)
Minimum 10 years of experience in Finance, M&A, Private Equity, Investment Banking, or related fields, with a strong understanding of the convenience store (C-store), retail, or comparable industries
Proven ability to conduct financial modeling, valuation, and pro forma analysis
skilled in evaluating complex business scenarios and guiding high-impact investment decisions
Demonstrated success in negotiating letters of intent, purchase agreements, and deal terms
leading acquisition integration from change in control through full operational conversion
Experience supporting international M&A initiatives, including joint ventures and strategic partnerships in new markets
Familiarity with digital transformation, store innovation, and emerging technologies relevant to retail and consumer experience
Strong network-building capabilities with private equity firms, venture capitalists, investment banks, accelerators, and startups

Job Responsibility

Rapidly assess and prioritize potential investment or acquisition opportunities to ensure strategic alignment before allocating team resources
Lead M&A team to develop detailed acquisition site assessments and characterizations for each site
Clearly communicate strategic intent to the M&A team and establish the basis for economic assumptions used in investment modeling
Determine key drivers for a successful transaction based on appropriate cross-functional input from internal and external stakeholders and experts
Drive cross-functional alignment on final model assumptions and lead senior-level engagements—including Board presentations—for evaluation, feedback, and approval
Effectively engage with stakeholders across all levels of the organization, including leadership at the parent company (Seven-Eleven Japan & Seven & I Holdings)
Review and validate pro forma financials and valuation models to support informed decision-making on acquisition opportunities
Lead scenario planning and sensitivity analyses to deepen evaluation of strategic investment decisions
Collaborate with Legal to draft letters of intent and formally present valuation and deal terms to the seller, target company, or broker
Lead negotiation of Letters of Intent and Purchase Agreements, overseeing due diligence, strategic planning, and seamless integration of acquisitions

Fulltime

New

Hp pc sales representative

Become a part-time HP PC Sales Representative! As a Premium PC Sales Specialist,...

Location

United States , Miami

Salary:

19.00 USD / Hour

2020 Companies, Inc

Expiration Date

Until further notice

Requirements

High school diploma or equivalent required
Six (6) months prior sales, retail, telecom or marketing experience
Demonstrated knowledge of products and services
Excellent communication, presentation, interpersonal, and problem-solving skills
Impeccable integrity and commitment to customer satisfaction
Ability to multi-task in a fast-paced, team environment
Must be available to work evenings, weekends, and holidays as needed
Ability to maintain customer confidentiality
1-year job experience required

Job Responsibility

Demonstrate premium lifestyle HP PC products and accessories at a big box retail store
Engage and build rapport with customers by creating a memorable experience
Responsible for maintaining professional relationships with retail partners within the assigned store(s)
Train retail store associates on HP products, accessories, and services with a focus on PC innovation
Maintain merchandising for cleanliness, functionality, and demo-readiness
Responsible for reporting and competitive insights
Sell products and services in a retail store, kiosk, and/or event environments
Maintain professional interaction with both customers and fellow employees
Meet or exceed personal sales goals on a monthly basis
Courteously welcome customers and offer assistance

What we offer

Consistent weekend schedule
Next day pay on-demand with DailyPay
Friday, Saturday, or Sunday availability
Paid training completed online
$25 per month Technology Reimbursement
Represent one of the most environmentally friendly companies worldwide

Parttime

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

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Location:United Kingdom , Cambridge ▼LondonUxbridge

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