Associate Director - Global Clinical Program Management Job at Amgen (Cambridge)

Associate Director, Regulatory

This role will serve as the Regulatory Lead for our pivotal program leading to B...

Location

United States , Philadelphia

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

Bachelor's degree in life sciences or related field required (advanced degree preferred)
Minimum of 5 years of experience in regulatory affairs for biopharmaceuticals or cell therapy (preferred)
Strong understanding of the drug development process from pre-clinical to commercialization, (prior BLA experience required)
Experience in reviewing and writing regulatory submission documents for global regulatory filings such as IND, CTAs, and BLAs/MAAs and related health authority interactions
Knowledge of GXPs and key requirements for clinical, nonclinical and CMC documentation for regulatory submissions in ICH regions
Excellent communication, negotiation, and leadership skills
Strong team orientation and passion for continuous self-development

Job Responsibility

Regulatory Strategy Development: Manage all regulatory aspects of Cabaletta’s lead program through pivotal clinical studies and BLA/MAA approval, including the preparation of clinical trial applications, amendments, correspondence, applications for expedited programs, health authority meetings, marketing applications, and labeling and promotional reviews for regulatory agencies, including FDA, Health Canada, EMA, MHRA and other countries, as applicable
Collaborate with cross-functional teams including clinical and nonclinical development, manufacturing, quality assurance, and medical affairs to develop and implement competitive regulatory strategies that expedite development and maximize the probability of success for cell therapy product development
Stay informed about evolving regulations and guidelines related to cell therapy and adapt strategies accordingly
Assess and communicate potential regulatory risks and propose mitigation plans
Regulatory Submissions and Compliance: Prepare and oversee the submission of regulatory documents, including INDs, CTAs, BLAs/MAAs, and other relevant submissions to regulatory agencies (e.g., FDA, EMA)
Ensure the quality and accuracy of regulatory submissions, adhering to timelines and requirements
Ensure compliance of programs and submission documentation with current regulations and guidelines governing cell therapy products
Regulatory Interactions: Represent the company during interactions with regulatory agencies, including meetings, teleconferences, and written communication
Prepare meeting requests, briefing documents, and coordinate and prepare teams for meetings with health authorities
Coordinate and prepare responses to requests for information from regulatory agencies

What we offer

health and retirement, PTO, and stock option plans

Associate Director, Commercial Learning & Capability Delivery – Enzymes Therapies

As Associate Director, Commercial Capability & Learning Delivery – Enzyme Therap...

Location

United Kingdom , London

Salary:

Not provided

BioMarin Pharmaceutical

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Science required, advanced degree preferred
Minimum of 7 years of demonstrated success in sales training and/or sales experience within biotech or specialty pharmaceutical areas (e.g., oncology, cardiovascular)
Extensive experience in designing and delivering Therapy Area and Product Training programs is required
Experience with product launches, specialty pharmaceutical environment/rare disease is strongly preferred
Proficient in leveraging Learning Management Systems to optimize training delivery and learner engagement
Capability Architect, not just a Trainer – Bring strong business acumen and systems thinking
Facilitation Excellence – An engaging presenter and coach
Instructional Design & Delivery Mastery – Deep expertise in adult learning principles
Scientifically Grounded: Demonstrates fluency in clinical data, disease state education, and product mechanisms of action
Business Impact Owner – Demonstrated expertise in defining and tracking KPIs

Job Responsibility

Spearhead the design and delivery of transformative capability programs for Enzyme Therapies across EMEA and APAC
Partner with global colleagues to co-develop the Global Learning Plan and translate it into a regional roadmap
Serve as a global-to-local connector, ensuring programs resonate regionally while scaling globally
Leverage AI-enabled tools and digital platforms to design and personalize curricula across modalities
Act as a competitive readiness shaper, co-developing regional contributions to the global playbook
Reinvent how virtual learning is delivered in the region
Cultivate strong partnerships with field, marketing, medical affairs, and market access leaders
Manage regional vendors, budgets, and contracts
Ensure all learning programs are designed, delivered, and validated in strict alignment with pharma compliance, regulation, and validation standards
Use learner feedback, business outcomes, and analytics to continuously improve program design and demonstrate measurable impact

Fulltime

Associate Director Global Clinical Program Management

In this vital role you will lead the operational delivery of complex clinical pr...

Location

United States

Salary:

182145.00 - 212860.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

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
Minimum of 3 years’ experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources

Job Responsibility

Lead the operational planning and delivery of multiple clinical studies or programs, ensuring timelines, budget, quality, and strategy are met
Proactively identify delivery risks and guide course-correction to keep studies on track
Drive consistent, high-quality operational practices across all assigned studies and programs
Line-manage and develop Study Delivery Leads, setting clear objectives and fostering high performance
Oversee program-level issues, risks, and escalation, ensuring timely and effective resolution
Partner cross-functionally and with local execution teams to align priorities, resources, and delivery plans
Provide strategic input on study design, country selection, enrolment, diversity, and patient-centric approaches
Manage program-level budgets, vendors, and forecasting while embedding lessons learned and continuous improvement

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, Clinical Data Manager

Associate Director, Clinical Data Manager (Sponsor Dedicated). ICON plc is a wor...

Location

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Advanced degree in Data Science, Statistics, Bioinformatics, or a related field
Experience in all aspects of Data Management related clinical study planning and execution, and in executing the complete range of clinical study activities, from concept sheet through final study report and archiving
Proven experience as Clinical Data Manager in the pharmaceutical/biotechnology industry, equivalent to at least 10 years
Substantial project management experience
Strong leadership competencies and influencing skills
Effective oral and written communication skills
Proven team dynamic knowledge and skills and ability to foster partnerships across projects and multidisciplinary teams
Growing expertise in drug development, including some knowledge of interfaces and interdependencies of clinical development with other functions (e.g., nonclinical & pharmaceutical development, regulatory, commercial/marketing)
Successful completion of multiple studies from beginning to end providing a full scope of DM experience

Job Responsibility

Leading Data Management including centralized monitoring related activities within a complete clinical development program (Phase I-IV, Accountable and Project Leadership) for global or regional trials and/or programs with different complexity
Serving as the escalation point, work with CRO data managers, vendors, internal team members for resolution
Ensures and tracks data quality of clinical database/deliverables (incl. CRF and non-CRF data) and submission readiness of the clinical data management deliverables and data packages (e.g. CDISC)
Project management of all clinical data management related deliverables including operationalization by steering internal and external experts and specialist. Ensuring adherence to planned time, cost and quality
Execution of the clinical data collection strategy in accordance to Sponsor Standards
Accountable for oversight of CROs in the execution of Phase I – IV clinical trial(s)
Represents Data Management within the Global Trial Team and serves as the key Global Development Operations point of contact for the DM related tasks in a trial/project/program
Key contributor to the development of reports and communicating to relevant line management and Clinical Operations Teams
Drives, leads and manages the successful execution, oversight and approval of all DM related clinical trial documents and operational plans (e.g. Data Management Plan) of clinical trials using strong project management, leadership, and organizational skills
Ensures strong oversight, review and delivery of trial/project DM related CAPAs in order to meet corporate compliance standards and timelines

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

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

Business Development Associate

This role is responsible to drive sales, expand market share and increase produc...

Location

Singapore

Salary:

Not provided

Avanos

Expiration Date

Until further notice

Requirements

Candidate with Nursing, Biomedical, Biotechnology or Science background preferred
At least 5 years of experience in related experience
Track record of profit/margin maximization, revenue growth, execute programs, manage projects and campaigns
Possess product training experience to clinical users and distributors
Strong understanding and identification of customers and their needs, clinical environment, competitive landscape and trends
Experience creating clinical acceptance and drive adoption of new treatments/therapies/technologies
Broad-based knowledge of medical consumables sales and marketing processes
Highly self-motivated, results-oriented with a drive and passion to succeed
Exceptional people skill and customer service oriented
Good communication and presentation skills

Job Responsibility

Drive sales, expand market share and increase product branding and awareness for the Company’s best-in-class products and business in assigned markets within Central Asia, mainly in Singapore
Participate in clinical cases, cadaver workshops and conferences
Perform equipment in-service maintenance and monitoring
Deliver product trainings to internal and external stakeholders e.g. sales team, physicians, clinical users, distributors, etc. to ascertain a solid understanding of AVANOS products, relevant technologies and application
Support operating procedures in the hospitals
Work closely with the Business Development Manager, Central Asia, ASEAN Sales Team, APAC Marketing Team to ensure the alignment of global, regional and local strategies, with the aim to elevate the company’s brand and improve product adoption efficacy through driving demand, sales and market expansion in the assigned markets
Work closely with cross-functional teams to own and drive customer satisfaction, product compliance, innovation and margin improvement
Be responsible for leading and building the Avanos Pain business mainly in Singapore
Achieve and exceed regional sales and financial budget and operational objectives
Drive growth on strategic focus products via increasing brand awareness and customer loyalty to Avanos products

What we offer

Comprehensive and competitive range of benefits
Total Rewards package encompasses everything you receive as an employee
your pay, health care benefits, retirement plans and work/life benefits

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

Trial Vendor Senior Manager

Parexel is currently registering interest for Trial Vendor Senior Manager to joi...

Location

United Kingdom

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Bachelor's degree or equivalent degree is required, with advanced degree preferred
3+ years working experience and excellent knowledge of the clinical operation processes and vendor management
Excellent knowledge of GxP and ICH regulations
Very good knowledge of clinical trial design and mapping to supplier requirements
Experience working with diverse cross-functional teams and a matrix environment and driving organizational excellence
Experience in User Acceptance testing for e-COA and IRT
Knowledge of key deliverables that impact green light milestones and vendor readiness
Experience or Expertise with Central Labs, Electronic Clinical Outcomes Assessment (eCOA), and Electronic Patient Reported Outcome (ePRO), Interactive Response Technology (IRT), Cardiac and Respiratory diagnostics, Patient Recruitment and Retention (PR&R), and/or Imaging reading (global process ownership, business system owner, SOP management, global training on supplier related SOPs and processes)
Very strong vendor management skills
outsourcing, contracting, and sourcing of clinical services

Job Responsibility

Interacts and collaborates closely with study team lead and study team members during study lifetime
Reviews vendor related protocol sections during protocol development
Collaborates with Vendor Study Manager (VSM) to the development of Study Specification Worksheet (SSW) to facilitate bid process
Manages interface with vendors in cooperation with vendor partner functions
Quote/proposal review in collaboration with procurement, support contract negotiations, if required
Contributes to the development of vendor contract amendments
Accountable for vendor cost control, budget review, invoice reconciliation and PO close-out
Manages vendor service excellence at study level, ensures vendors meet quality and service level standards in their service delivery for the trial
Covers all vendor activities after study start-up and all categories not covered by VSMs during start-up
Initiates/co-ordinates vendor kick-off meeting for categories not covered by VSMs

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Associate Director - Global Clinical Program Management

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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Associate Director - Global Clinical Program Management

Amgen

Location:United Kingdom , Cambridge ▼LondonUxbridge

Category:-

Contract Type:Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:February 18, 2026

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