Clinical Development Lead in Burgess Hill

The Clinical Development Lead is an integral member of the Clinical Development Clinical Evidence In‑Vitro Diagnostics (CEI) team at Roche Diagnostics Solutions (RDS). The role focuses on providing documentation support for a wide range of clinical study documents, including reports, protocols, clinical study reports, investigator brochures, and IVDR performance evaluation documents. The Lead serves as a strategic partner in supporting clinical evidence generation and clinical study design for in‑vitro diagnostics (IVD) registration with regulatory agencies.

Responsibilities

• Design scientifically sound clinical studies in collaboration with subject‑matter experts and other functions.
• Participate in project teams to support study design and execution, including protocol and report generation and critical review of study results.
• Analyze the product portfolio across a specific customer area to create documentation that supports compliance with IVD regulation.
• Conduct comprehensive literature reviews, collate relevant clinical and scientific information, and generate new scientific content with minimal guidance.
• Provide medical and scientific input into regulatory submissions and respond to reviewers from regulatory agencies.
• Partner with the Medical Affairs‑Scientific Communications team to offer ad‑hoc writing support for manuscripts, posters, and advisory board materials.
• Oversee and manage the entire document lifecycle, ensuring timely delivery of high‑quality documents in accordance with Roche procedures and regulatory requirements.
• Share best practices and lessons learned with the CEI team, and support process improvement activities such as GSP/template updates, collaborative work‑tool management, quality control enhancements, and automation opportunities.
• Manage project timelines, coordinate cross‑functional meetings, and maintain effective communication with stakeholders.
• Mentor less experienced team members and foster a continuous‑improvement work environment.
• Maintain up‑to‑date clinical, regulatory, and scientific expertise related to IVD product development and documentation.

Qualifications

• Advanced degree (PhD, PharmD, MD, etc.) in life sciences, pharmacology, biomedical engineering, biostatistics/epidemiology, clinical research, or a related field.
• Solid scientific research experience and proven scientific writing skills in an academic or industry setting, including clinical study protocols and reports.

Preferred Qualifications

• Experience with regulatory writing for in‑vitro diagnostics or medical devices, including companion diagnostics.
• Understanding of laboratory techniques such as PCR, sequencing, serology, microbiology, clinical virology, immunohistochemistry, and immunological assays.
• Knowledge of basic statistical techniques.
• Ability to travel up to 25% of the time.

Location

Primary location: Burgess Hill.

EEO Statement

All qualified applicants will receive consideration for employment without regard to race, religion or belief, sex, gender reassignment, sexual orientation, marriage and civil partnership, pregnancy and maternity, disability or age. We recognise the importance of flexible working and will review all applicants’ requests with care. At Roche both diversity drives innovation and we are committed to building a diverse and flexible working environment for all employees. Qualified applicants are encouraged to bring their whole selves to work.