Biotech

Role

• Develop strategies addressing both biologic/drug and device components and align with company goals and regulatory expectations.
• Comprehend regulations, regulatory standards, directives, guidelines and advise Development, Technical Operations, and Quality teams on their applicability to and impact on product development projects.
• Lead plans and protocols for compatibility, design verification and functional stability studies, as well as  contribute to the design of human factor studies and usability testing.
• Provide strategic input to Design Control processes and documentation, ensuring alignment with health authorities and notified body requirements and global technical standards. Review DHF documentation from a regulatory perspective.
• Design and execute submission strategies for device-related dossier components (INDs/CTAs, marketing applications, and post-approval changes) in collaboration with company SMEs.
• Conduct research for the development of state-of-the-art studies.
• Operating effectively in a matrixed environment, influence cross-functional decision-making without direct authority.
• Assess change controls to identify and mitigate any regulatory risks.
• Lead health authorities and notified body interactions.
• Oversee device-related regulatory information in company systems.
• Support other Regulatory CMC activities.

 

Requirements

• Experience as the regulatory lead for combination products in pharmaceutical, biotechnology, or medical device industry setting.
• Prior and proven experience in late stage development of combination products.
• In-depth and broad experience with regulations, standards, directives, guidelines and requirements related to the use of combination products in global clinical trials and commercial registration.
• Strong understanding of ISO and ASTM standards relevant to combination products.
• Up to date with current industry trends and regulatory expectations associated with combination products.
• Good knowledge of ICH guidelines and GMP requirements for the development and manufacturing of biologics.
• A successful candidate will have strong communication skills, strategic acumen, collaboration, and influencing attributes.
• A bachelor's degree preferably in a scientific/engineering discipline

I am currently partnered with a small Biotech client who focus on innovative Respiratory studies in their search for a Clinical Project Manager to join the team on a 12 month fixed term contract for a maternity cover.

 

Days per week: 5

Location: Fully remote in the UK

Salary: £65,000 - £70,000

 

The ideal background for this role is someone who has project management experience in the pharmaceutical sector and knowledge of CMC. Small biotech backgrounds are preferred.

Summary

The Project Manager is responsible for managing and delivering on the non-clinical aspects of our small Biotech's lead program working with the function leads according to the agreed development plan. The Project Manager reports directly to the CEO and is responsible to the CEO for the delivery of the non-clinical plan to the timeline and objectives.

 

The Project Manager is responsible for managing the non-clinical program as an influential, capable and credible project management professional. Reporting to the CEO, the Project Manager has accountability for the program to progress on time and budget. The individual contributes to creating a safe working environment, and an inclusive, agile and collaborative culture for employees and consultants as well as maintaining excellent relationships with service providers to the Company.

 

The Project Manager position sits within the Development Group of our client and the post-holder will provide high-level project management skills to lead the development program for the treatment of disease.

 

Key Responsibilities

• Ensure that the non-clinical development programs (objectives and timelines) are clearly communicated and understood by all required parties.
• Working with the CEO and the function leads to develop and agree a detailed non-clinical development plan aligned to the Company’s development goals.
• Support the function leads in the generation of Request for Proposals and contractor selection.
• In co-ordination with the function leads and CEO, manage the Company’s relationship with its CROs,
• Liaising with the laboratory-based team, communicating the Company’s development goals,
• Contribute to the overall scientific excellence of the development activities.
• Coordinate the non-clinical team’s activities according to project plans and timelines.
• Monitor non-clinical budgets and attend frequent forecast meetings.
• Flexibly work across all activities in the non-clinical program to ensure oversight.
• Review protocols and reports generated across the project, as well as identifying appropriate members of the team to also review.
• Develop and monitor non-clinical project plans and Gantt charts.
• Lead frequent development risk management brainstorming meetings and, as required, issue management meetings – recording the outcomes of these as required.
• Coordinate sponsor sign-off and filing of documents.
• Provide frequent updates on development activities to the CEO.
• Take leadership of the Company’s quality system to meet its obligations as Sponsor.

 

Please apply here and Harry Henson will be in touch to discuss your application further.

 

*while the job title is Clinical Project Manager this role is actually non-clinical and more focused within the CMC side, but Clinical candidates are welcome to apply and will be considered

A clinical-stage biotech is seeking a Safety Physician to support ongoing safety activities across late-stage clinical development programs. This role will focus on medical review of safety data, signal detection, and contribution to risk management strategies, ensuring high-quality safety oversight and regulatory compliance across Phase 3 studies.

 

This is a contract opportunity supporting innovative programs in autoimmune and neurology indications.

 

What You'll Do

• Provide medical review of ICSRs, including assessment of seriousness, expectedness, and causality
• Monitor safety data across multiple sources to ensure data quality and consistency
• Contribute to safety sections of clinical documents (protocols, IBs, ICFs, DSURs, safety reports)
• Support signal detection activities and participate in signal review discussions
• Review case listings and support resolution of coding or reconciliation discrepancies

 

Qualifications

• MD or international equivalent required with 3+ years of pharmacovigilance experience within global clinical trials
• Experience with ICSR medical review and safety data evaluation
• Working knowledge of MedDRA coding and safety databases
• Strong understanding of global PV regulations (FDA, EMA, ICH)
• Experience in autoimmune, neurology, or related therapeutic areas preferred

 

If you’re a Safety Physician looking to contribute to innovative clinical programs in a flexible contract setting, please apply or reach out to learn more: cait.dawson@rbwconsulting.com