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

New

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

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

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

Quality Compliance Manager

We are hiring a Quality Compliance Manager, which will operate within the Genera...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree
Master’s degree and 2 years of quality management experience
Bachelor’s degree and 4 years of quality management experience
Associate’s degree and 8 years of quality management experience
High school diploma / GED and 10 years of quality management experience
Experience in Quality Management, Quality Assurance or other relevant areas of the pharmaceutical/biotech industry where risk-based quality and quality by design are a core responsibility
Oversight and implementation of Quality Management Systems and experience managing quality in electronic QMS such as Veeva or Track wise
Thorough understanding of Clinical R&D activities and Global Regulations
Knowledge of the Regulatory Submission and Inspection Management procedures
Quality Oversight of Clinical Trials, including clinical trial protocol development, execution, and submissions

Job Responsibility

Provide proactive end to end quality support for the development and implementation of a risk-based quality assurance strategy
Provide independent and objective quality advice in support of clinical trial activities
Provide quality oversight for Amgen programs for all stages of products in clinical development
Ensure quality oversight for the Risk Assessment Categorization Tool (RACT) for each trial
Support the establishment of regional expertise to ensure quality and compliance to local Regulations
Support Clinical Trial Teams for all quality management activities
Ensure TA-specific data integrity
Review clinical trial protocols
Actively seek and implement innovative and proactive quality oversight methodologies
Manage/support regulatory inspection and review responses

What we offer

A 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
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models, including remote and hybrid work arrangements, where possible

Fulltime

Associate Director, Statistical Programming

This is a critical role responsible for leading statistical programming activiti...

Location

United States , Waltham

Salary:

160000.00 - 200000.00 USD / Year

Kailera Therapeutics

Expiration Date

Until further notice

Requirements

Minimum of 7+ years of relevant experience with MS
5+ years of relevant experience with PhD
Proven hands-on experience in programming for clinical development, preferably in a leadership role, with a strong preference for late-phase clinical trial support
Experience in regulatory submissions, including NDAs, BLAs, and other filings, with experience in ISS/ISE highly desirable
Expertise in SAS programming and comprehensive knowledge of CDISC standards
Familiarity with ICH/GCP guidelines and global regulatory submission requirements (e.g., FDA, EMA)
Extensive experience overseeing CROs, including independent validation of datasets and statistical deliverables
Advanced degree (MS/PhD) in Biostatistics, Statistics, or a related field

Job Responsibility

Lead statistical programming efforts for clinical studies, including the development and review of programming specifications to ensure clarity, integrity, and compliance with internal and external standards
Oversee and coordinate activities with Contract Research Organizations (CROs), focusing on the implementation of CDISC standards, creation of SDTM, ADaM datasets, and TFLs, and ensuring high-quality deliverables
Conduct independent validation and quality checks of statistical programming deliverables from CROs
Collaborate closely with statisticians and cross-functional study teams to deliver results in a timely and accurate manner
Manage multiple projects simultaneously, ensuring tasks are prioritized effectively to meet deadlines

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, Statistical Programming

This is a critical role responsible for leading statistical programming activiti...

Location

United States , Waltham

Salary:

160000.00 - 200000.00 USD / Year

Kailera Therapeutics

Expiration Date

Until further notice

Requirements

Minimum of 7+ years of relevant experience with MS
5+ years of relevant experience with PhD
Proven hands-on experience in programming for clinical development, preferably in a leadership role, with a strong preference for late-phase clinical trial support
Experience in regulatory submissions, including NDAs, BLAs, and other filings, with experience in ISS/ISE highly desirable
Expertise in SAS programming and comprehensive knowledge of CDISC standards
Familiarity with ICH/GCP guidelines and global regulatory submission requirements (e.g., FDA, EMA)
Extensive experience overseeing CROs, including independent validation of datasets and statistical deliverables
Advanced degree (MS/PhD) in Biostatistics, Statistics, or a related field

Job Responsibility

Lead statistical programming efforts for clinical studies, including the development and review of programming specifications to ensure clarity, integrity, and compliance with internal and external standards
Oversee and coordinate activities with Contract Research Organizations (CROs), focusing on the implementation of CDISC standards, creation of SDTM, ADaM datasets, and TFLs, and ensuring high-quality deliverables
Conduct independent validation and quality checks of statistical programming deliverables from CROs
Collaborate closely with statisticians and cross-functional study teams to deliver results in a timely and accurate manner
Manage multiple projects simultaneously, ensuring tasks are prioritized effectively to meet deadlines

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 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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Location:United Kingdom , Cambridge ▼LondonUxbridge

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Job Description:

Job Responsibility:

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