Clinical Development Lead

At Roche Diagnostics Solutions (RDS), the Clinical Development & Medical Affairs (CDMA) team drives innovation to improve healthcare outcomes globally. The Clinical Development Lead is an integral member of the Clinical Development Clinical Evidence In‑Vitro Diagnostics (CEI) team whose primary focus is providing documentation support for a multitude of clinical study documents, including reports, protocols, clinical study reports, investigator brochures, etc., and IVDR performance evaluation documents. The position will function as a strategic partner within Clinical Development to support clinical evidence generation and/or clinical study design of In‑Vitro Diagnostics (IVD) for registration with regulatory agencies.

Responsibilities:

• Design scientifically sound clinical studies in conjunction with subject matter experts (SMEs) from CDMA and other functions to support new product development.
• Actively participate in project teams/extended project teams to support clinical study design and execution activities, including protocol and report generation, critical review of study results, etc.
• Strategically support clinical evidence generation by analyzing the product portfolio across a specific customer area and creating documentation to support compliance to IVD‑Regulation.
• Conduct comprehensive literature reviews, cohesively collate relevant clinical and scientific information from different sources, and create new scientific content with minimal guidance/direction.
• Provide medical/scientific input into and assist with the preparation of regulatory submissions. Provide responses to reviewers from regulatory agencies, as applicable.
• Partner with the Medical Affairs‑Scientific Communications team to offer ad‑hoc writing support for select manuscripts, posters, and advisory boards.
• Oversee and manage the entire document lifecycle. Serve as primary contact for assigned work and ensure the timely delivery of high quality documents in accordance with relevant Roche procedures, regulatory requirements, and quality control systems.
• Interface closely with other members of the CEI team to share best practices, transparently communicate project/customer area‑related lessons learned, and support team management and process improvement activities.
• Responsible for proactive timeline management, project and process management, cross‑functional meeting coordination, effective communication, building healthy relationships with team members, actively participate in team meetings, demonstrate attention to detail, and simultaneously lead several projects to completion.
• Successfully complete all assigned curricula and on‑the‑job training modules.
• Act as a mentor to less experienced members of the CEI team.
• Foster an engaged work environment that strives for continuous improvement, professional development, living the Roche cultural beliefs, and exhibits skills of agility, effective decision‑making, adaptability to change and influencing without authority.
• Maintain clinical, regulatory, and scientific expertise as it relates to IVD product development and regulatory documentation.

Who You Are:

• You have an advanced degree (e.g., PhD, PharmD, MD, etc.) in life sciences, pharmacology, biomedical engineering, biostatistics/epidemiology, clinical research, or other related fields.
• You have solid scientific research and proven scientific writing experience in an academic or industry setting with a variety of clinical or regulatory documents, including clinical study protocols and reports.

Preferred Qualifications:

• You have experience with regulatory writing for in‑vitro diagnostics or medical devices, including companion diagnostics.
• You have an understanding of laboratory techniques in one or more of the following areas: PCR, sequencing, serology, microbiology, clinical virology, immunohistochemistry, immunological assays.
• You have an understanding of basic statistical techniques.
• You have the ability to travel up to 25%.

We look forward to your application!