Job Description

Biocomposites is an international medical devices company that engineers, manufactures, and markets world leading products for use in infection management in bone and soft tissue. Based in Keele, UK, it has global operations across Europe, USA, Argentina, Canada, China, and India. Biocomposites is a world leader in the development of innovative calcium compounds and bone cements for surgical use. Its products regenerate bone and target infection risks across a variety of specialties, including musculoskeletal infection, orthopaedics, trauma, spine, foot and ankle, podiatry, and sports injuries. Biocomposites products are now used in over one million procedures per annum and sold in more than 100 countries around the world.

Job Summary

The Pre-Clinical research specialist role is a science driven position, where your experience and expertise will directly influence the research and development activities of new medical device and drug products. The activities will include the research and development activities needed for regulatory submissions and clinical trials and will include oversight and strategy for biocompatibility testing, toxicological risk assessments, animal studies and other pre clinical testing required for the products in development.

The postholder will collaborate cross functionally within the R&D, regulatory affairs, and clinical development teams, whilst also working closely with CRO's and vendors, to ensure testing is conducted in line with regulatory requirements.

The post holder will ensure pre-clinical testing is conducted according to standards and ensuring the data is provided in a suitable format to support regulatory submissions. The postholder will also be experienced in scientific writing, have good communication skills, and project management to ensure the projects are completed on time.

Responsibilities:

• Lead and manage the preclinical research activities for strategic R&D projects within the company and provide your expert input in this field.
• Work seamlessly in the R&D team to oversee the preclinical research activities, helping to define timelines, budgets and contingency planning.
• Coordinate with third parties, including CROs, development/commercial partners, and academic centres, to execute the strategy.
• Support the Preclinical submissions and interactions with regulatory agencies such as the FDA, MHRA, EMA, etc.
• Ensure preclinical studies comply with SOPs, regulatory guidelines, and ICH requirements.
• Have the ability to relay complex information to both internal stakeholders and external collaborators
• Define biological risks and shape preclinical strategy for medical devices and combination products that are under development.
• Design, coordinate and interpret preclinical safety and biocompatibility studies.
• Ensure compliance with ISO 10993 series, FDA guidance, EU MDR and global regulations.
• Write, review, and deliver high-quality scientific documentation: protocols, reports, and regulatory submissions (e.g., IDE, 510(k), IND, NDA).
• Act as preclinical lead in cross-functional projects and external collaborations.
• Contribute to risk assessments per ISO 14971 and biological evaluations per ISO 10993-1;
• Leading and overseeing all animal studies, from design to completion, ensuring compliance with regulatory requirements.
• Developing protocols for in-vitro and animal experiments required for regulatory submissions.
• Ensuring proper documentation and technical writing of results required for regulatory submissions.
• Ability to manage multiple projects and work to deadlines.

Required Experience:

• Excellent scientific writing and communication skills.

• Bachelor's degree in a scientific or health related discipline.

• A minimum of 5 years of experience in the clinical trials Pharmaceutical, Biotechnology, and/or CRO industry is required with a preference towards individuals who have experience in site engagement or an investigator facing role.

• Significant track record driving Preclinical / Non-clinical research within a pharmaceutical, biotech or CRO company.

• Strong background in biocompatibility testing and toxicological risk assessment.

• Proven experience in animal study protocol development and execution.

• Experience of managing CROs and outsourced preclinical studies.

• Knowledge of relevant legislation and guidelines and standards pertinent to preclinical testing e.g. ISO 10993

• Project planning, is well organized, detail oriented and capable of successfully managing multiple projects.

• Strong team orientation: demonstrates initiative to solve problems and improve efficiency.

• High degree of proficiency in Microsoft Excel, PowerPoint and Word.

• Strong written and oral communication skills.