Manufacturing Quality Engineer

Oncology Clinical Development | Early Phase Biotech

A rapidly growing clinical-stage biotechnology organization is seeking two experienced Senior Clinical Project Managers / Senior Clinical Study Managers to support the execution of global oncology clinical trials across early and late-stage development.

These individuals will play a critical role in leading complex international studies, including First-in-Human (FIH) programs involving novel biologic therapies. This is an opportunity to join a highly collaborative and scientifically driven clinical operations team focused on advancing innovative oncology treatments in a fast-paced development environment.

 

Key Responsibilities

Global Clinical Trial Leadership

• Lead the end-to-end operational execution of global Phase I–III oncology studies from startup through closeout
• Oversee timelines, budgets, quality, and cross-functional deliverables to ensure successful study execution
• Support protocol development, country/site activation strategies, enrollment planning, and study reporting activities
• Drive operational excellence across complex oncology programs, including FIH and registration-enabling studies

Study Oversight & Vendor Management

• Manage CROs and external vendors across monitoring, data management, imaging, laboratories, ePRO, and related services
• Proactively identify operational risks and implement mitigation strategies
• Ensure inspection readiness and compliance with ICH-GCP, SOPs, and global regulatory requirements
• Oversee forecasting, accruals, budget tracking, and change order management

Cross-Functional Collaboration

• Lead global study team meetings and facilitate effective decision-making across stakeholders
• Partner closely with Clinical Development, Medical, Regulatory, Biometrics, Safety, and external collaborators
• Build and maintain strong relationships with investigators, academic institutions, and key external partners

 

Qualifications

Required Experience

• 10+ years of clinical operations experience within biotech, pharma, or CRO environments
• 5+ years leading global oncology clinical trials
• Strong experience supporting early phase oncology studies, including FIH, dose escalation, and expansion cohorts
• Demonstrated success managing global CROs and multi-vendor clinical programs
• Deep understanding of oncology drug development and complex clinical trial operations
• Strong knowledge of ICH-GCP and global regulatory standards
• Excellent leadership, communication, and stakeholder management skills
• Ability to operate independently in a fast-paced and evolving environment

Preferred Background

• Experience with immuno-oncology, targeted therapies, or solid tumor indications
• Exposure to registration-directed or late-stage studies
• Prior experience within small or emerging biotech companies
• Advanced scientific degree and/or project management certification preferred

 

Why This Opportunity?

• High visibility role within a growing oncology organization
• Opportunity to lead innovative global oncology studies from early development onward
• Collaborative, science-driven culture with strong executive exposure
• Meaningful impact on cutting-edge therapies for patients with unmet medical needs

Cardiovascular Medical Device | Clinical-Stage Innovation

An innovative and rapidly growing clinical-stage medical device organization is seeking experienced Clinical Research Associates to support a pivotal cardiovascular clinical program. This is an exciting opportunity to join a highly collaborative clinical operations team developing next-generation technologies in a fast-growing therapeutic area.

The organization is advancing a novel structural heart platform through ongoing clinical development and expanded global trial activities. These hires will play a critical role in supporting investigative sites, driving study execution, and ensuring operational excellence across clinical trial activities.

Candidates may be considered at either the CRA II or Senior CRA level depending on experience and qualifications.

 

Key Responsibilities

Site Management & Monitoring

• Serve as the primary point of contact for assigned investigational sites
• Conduct qualification, initiation, interim monitoring, and close-out visits
• Provide site training for investigators, coordinators, and research staff
• Ensure compliance with study protocols, GCP, SOPs, and applicable regulatory requirements
• Support site performance, enrollment progress, and subject retention efforts

Clinical Operations Support

• Support study startup activities, including IRB/EC submissions and essential document management
• Maintain inspection readiness of study documentation and eTMF systems
• Contribute to the development of study-related materials, including manuals, worksheets, and training tools
• Assist with investigational product management and clinical vendor coordination
• Participate in data review activities, query resolution, and EDC support

Cross-Functional Collaboration

• Partner closely with internal clinical operations, data management, regulatory, and quality teams
• Participate in project meetings and provide regular site and study status updates
• Identify operational risks and proactively escalate issues when appropriate
• Support audit readiness activities and clinical inspection preparation

 

Qualifications

Required Experience

• Minimum 5+ years of direct clinical monitoring and site management experience
• Experience managing clinical trial sites from startup through closeout
• Strong understanding of ICH-GCP, FDA, and ISO regulations
• Excellent organizational, communication, and problem-solving skills
• Ability to manage multiple priorities in a dynamic environment
• Experience working independently and collaboratively across cross-functional teams
• Proficiency with EDC systems, Microsoft Office Suite, and clinical documentation platforms

Preferred Background

• Experience within medical device and/or cardiovascular clinical trials
• Experience working within small or emerging biotech/medtech organizations
• Exposure to pivotal or post-market clinical studies
• Prior experience supporting trials without heavy CRO oversight preferred

 

Additional Information

• Remote opportunity with preference for candidates located in the New England region
• Travel requirements may vary and could reach approximately 50% during peak study activity
• Opportunity to join a growing organization at an exciting stage of clinical development

 

This position offers the chance to make a meaningful impact within a highly innovative clinical program while working alongside an experienced and collaborative team dedicated to advancing patient care through cutting-edge medical technology.

A leading, global pharmaceutical manufacturing business is seeking an experienced Validation Engineer to support delivery of a major site validation and capital programme on a 12-month contract.

This is a high-impact role within a busy engineering environment, offering exposure across equipment, utilities, facilities, and laboratory systems, with a need for hands-on execution specialists. If this capability brings with it project lead experience, this will also be valued.

 

The Role

Working as part of the Engineering function, you will support delivery of a structured site-wide validation programme, alongside capital project activity.

Responsibilities will include:

• Supporting delivery of the Site Validation Master Plan (SVMP)
• Generating and reviewing validation / qualification documentation (IQ/OQ/PQ, FAT/SAT, etc.)
• Leading or supporting execution of validation activities across manufacturing, lab, and utility systems
• Working closely with internal stakeholders to ensure GMP and regulatory compliance
• Reviewing vendor documentation and supporting supplier-led validation activities
• Participating in FATs and site-based commissioning activities where required
• Managing or supporting third-party contractors and vendors
• Owning change controls, deviations, and CAPAs linked to validation activities
• Supporting requalification, new equipment introduction, and decommissioning activities

 

Project / Programme Exposure

In addition to core validation delivery, there is scope to contribute at a more strategic level:

• Supporting or leading capital project delivery (GxP and non-GxP)
• Defining project scope, timelines, and deliverables
• Managing project risks, budgets, and progress reporting
• Coordinating cross-functional stakeholders and teams
• Driving project governance, change management, and close-out activities

 

What We’re Looking For

We’re open to a range of profiles, from strong delivery-focused CQV engineers to more senior, project-led professionals:

• Experience in validation / CQV within GMP-regulated environments (pharma / biotech / related)
• Strong understanding of validation principles across equipment, utilities, or facilities
• Experience authoring and executing validation documentation
• Ability to work effectively across cross-functional teams and stakeholders
• Confidence operating in a fast-paced, project-driven environment
• Strong communication and problem-solving skills

We are exclusively supporting one of our longest standing clients in a significant expansion through the course of 2026.

As part of this, they are appointing a new position of Senior Quality Assurance Officer within their operational quality team on site in South London.

This person will strike the balance in hands on quality activities, as well as performing a deputy in absence of the Team Leader. As well as the usual operational quality activities such as batch release, deviation management and change control implementation, this person will need to take a lead on process ownership of investigation management and risk assessments.

If you enjoy working in a flat structured team, with broad responsibilities and a genuine opportunity for development, this could be the ideal career move.

This is a fully site based role in South London.

For further details, please contact Mark Bux-Ryan.

 

What you need to bring:

• Established QA experience within a GMP setting – ideally pharmaceuticals, although food manufacturing will be considered.
• Evidenced experienced of independent process ownership within QA activities – ideally investigation and risk assessment management
• Excellent stakeholder management skills
• Flexible and adaptable approach

We are seeking an experienced Head of Medical Writing to lead the strategy, development, and delivery of high-quality clinical and regulatory documents across all phases of drug development.

This role provides scientific and operational leadership for medical writing activities, supporting early- through late-stage programs and global regulatory submissions. The Head of Medical Writing will partner closely with Clinical Development, Regulatory Affairs, Biostatistics, and Safety to ensure accurate, timely, and compliant documentation.

 

Key Responsibilities

• Serve as the medical writing lead across one or more clinical programs
• Lead and/or author clinical documents including protocols, CSRs, and Investigator’s Brochures
• Support global regulatory submissions (INDs, NDA/BLA/MAA, health authority briefing documents, CTD Modules 2 and 5)
• Oversee timelines, coordinate cross-functional input, and ensure scientific accuracy and regulatory compliance
• Establish and maintain writing standards, templates, and best practices
• Facilitate efficient review cycles and ensure consistent scientific messaging across documents and programs
• Drive quality, process improvement, and scalable medical writing operations

 

Qualifications

• Advanced degree in life sciences (PhD, PharmD, MD, or MSc)
• 7–8+ years of medical writing experience in pharma, biotech, or CRO settings
• Strong experience across multiple phases of clinical development and global regulatory submissions
• Proven leadership in complex writing projects and cross-functional environments
• In-depth knowledge of ICH, GCP, and global regulatory requirements
• Experience in oncology, rare disease, or other complex therapeutic areas preferred

~20 Hours/Week

We are seeking a highly experienced biostatistical consultant to support a targeted therapy program in oncology, currently in pre-clinical to IND-enabling stages. This role will focus on studies where PK endpoints are critical to advancement, requiring strong expertise in adaptive study design and bioanalytical strategy.

This is a hands-on consulting opportunity suited for a biostatistician who thrives in early development environments and can operate independently while partnering cross-functionally.

 

Key Responsibilities

• Provide statistical leadership for studies designed to generate PK data in support of IND filings
• Lead and advise on adaptive study designs, including dose selection and optimization strategies
• Support and interpret bioanalytical (BA) and bioequivalence (BE) data to inform development decisions
• Contribute to study design, analysis planning, and data interpretation across non-clinical and early-phase development activities
• Collaborate closely with clinical pharmacology, bioanalytical, and development teams to ensure alignment on study objectives and deliverables
• Review and develop statistical input into protocols, analysis plans, and regulatory-facing documentation

 

Required Experience

• Significant experience in biostatistics within drug development, with a strong emphasis on adaptive design methodologies
• Deep expertise in PK-driven studies, particularly those supporting early development and IND-enabling work
• Proven experience with bioanalytical (BA) and bioequivalence (BE) data and study interpretation
• Background supporting oncology programs is preferred, though experience in PK-led development is prioritized
• Prior experience in biotech or pharmaceutical environments
• Ability to work autonomously in a part-time consulting capacity and navigate evolving program needs

 

Program Context

• Focused on targeted oncology therapies with limited public visibility
• Work will support progression toward IND filing rather than ongoing clinical trials
• High-impact role influencing early development strategy and decision-making

 

Engagement Details

• Part-time contract (~20 hours per week)
• Initial term of 12–18 months
• Flexible, remote working arrangement