Associate Medical Safety Director

Roche•Mississauga, ON

1d•Onsite

About The Position

At Roche, we advance science so that we all have more time with the people we love. Our Clinical Safety organisation is dedicated to delivering meaningful improvements to patients through medically-differentiated therapies. In this role, you will provide essential safety science and pharmacovigilance support to molecules across the Roche portfolio, ensuring the highest standards of participant safety and data reliability. As a Portfolio Clinical Safety Scientist (Associate Medical Director), you will be a key member of the safety team, providing medical expertise and safety oversight across the development and marketed portfolio. You will apply your clinical medical knowledge to deliver safety science and pharmacovigilance support, from early and late phase development through post-marketed signal and risk management. Working under the matrix leadership of the Safety Strategy Leader (SSL), you will ensure our medicines reach patients safely and efficiently.

Requirements

A formal medical degree (MD, MB BS, MB ChB) with post-graduate clinical experience in relevant medical specialties.
5+ years of clinical drug development experience in pharma or biotech, including at least 2 years specifically in clinical drug safety.
A solid understanding of GxP, regulated processes, and the end-to-end clinical trial lifecycle.
The ability to apply complex data analysis and statistical methods to interpret and present scientific data with clarity.
Strong written and verbal communication skills, with the ability to present key decision points effectively to diverse audiences.

Responsibilities

Develop and maintain an understanding of the safety profile for assigned products, providing clinical input into the interpretation of emerging safety data in the context of experience gained whilst practising in relevant areas of clinical medicine/healthcare.
Contribute to aggregate case analysis and reporting activities including preparation of periodic safety reports (ie. DSUR, PBRER)
Drive signal management activities, including signal detection and assessment, and contribute to risk management activities (e.g.RMPs/REM) and provide advice and interpretation of whether/how risks may impact the overall clinical risk-benefit balance of an asset, in the context of typical clinical medical practice in the territories/countries where the product/asset will be used.
Support the preparation and review of safety sections for regulatory filings (IND, NDA, MAA) and labeling documents like the Company Core Data Sheet, or Investigator’s Brochure
Represent Clinical Safety on development study teams and prepare and/or review safety sections of study documents (e.g. protocol, Informed consent, etc)
Contribute to and/or and provide input into internal or external Drug Monitoring Committees.
In partnership with the SSL, support presentation of safety issues to the internal Safety governance committee.
Coordinate with vendors and may act as a functional business process owner or subject matter expert to improve our safety science practices.
Partner with functions including Clinical Science, Regulatory, Data Science and Clinical Operations teams to ensure seamless execution of business initiatives.
Act as a subject matter expert within the function, coaching junior scientists.