Clinical Development Lead

Roche•Tucson, AZ

3d•$100,500 - $186,700

About The Position

The Clinical Development Lead is an integral member of the Clinical Development Clinical Evidence In-Vitro Diagnostics (CEI) team at Roche Diagnostic Solutions (RDS). Their primary focus includes providing documentation support for a multitude of clinical study documents, such as reports, protocols, clinical study reports, and investigator brochures, as well as IVDR performance evaluation documents. The position functions 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.

Requirements

Doctoral or advanced degree (e.g., PhD, MD, PharmD etc.) in life sciences, pharmacology, biomedical engineering, biostatistics/ epidemiology, clinical research, or other related fields.
5+ years of 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.

Nice To Haves

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

Responsibilities

Designs scientifically sound clinical studies in conjunction with subject matter experts (SMEs) from CDMA and other functions to support new product development.
Actively participates 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 supports clinical evidence generation by analyzing the product portfolio across a specific customer area and creating documentation to support compliance to IVD-Regulation.
Conducts comprehensive literature reviews, cohesively collates relevant clinical and scientific information from different sources, and creates new scientific content with minimal guidance/direction.
Provides medical/scientific input into and assists with the preparation of regulatory submissions.
Provides responses to reviewers from regulatory agencies, as applicable.
Partners with the Medical Affairs-Scientific Communications team to offer ad-hoc writing support for select manuscripts, posters, and advisory boards.
Oversees and manages the entire document lifecycle.
Serves as primary contact for assigned work and ensures the timely delivery of high quality documents in accordance with relevant Roche procedures, regulatory requirements, quality control systems/procedures, and journal requirements for scientific publications.
Interfaces 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 (such as GSP/template updates, managing collaborative work tools, improving quality control, exploring automation opportunities, managing reference libraries etc).
Responsible for proactive timeline management, project and process management, cross-functional meeting coordination, effective communication, building healthy relationships with team members, active participation in team meetings, demonstrating attention to detail, and simultaneously leading several projects to completion.
Successfully completes all assigned curricula and on-the-job training modules.
Acts as a mentor to less experienced members of the CEI team.
Fosters 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.
Maintains clinical, regulatory, and scientific expertise as it relates to IVD product development and regulatory documentation.