The Safety Science Senior Medical Director will work under the supervision of a Safety Science Group Director, be responsible for particular aspect(s) of an overall program or a group of products, work independently and provides leadership and mentoring to other members of the Group. In most cases, the Safety Science Senior Medical Director will have primary accountability for a program(s) and may have the role of Safety Science Leader(SSL) for a product/program.
The Safety Science Leader (SSL) is the safety science representative on the Global Development Team (GDT), Lifecycle Team (LCT), Clinical Science Team (CST), Established Products Team (EPT) and/or other related project teams and leads the cross-functional Safety Team. As such, the SSL is accountable for Safety deliverables for the product or program including the development and execution of the long-range safety strategic plans for the molecule, including the design, monitoring, analysis, and reporting of studies and other data sources throughout the product lifecycle. The SSL brings safety expertise to interactions with Health Authorities and Data Monitoring Committees and must have the ability to interact effectively in a multifunctional and multicultural team setting.
Job Responsibilities Product Development Safety Risk Management:
- Develop timely and scientifically sound clinical safety portions of a Product Development Plan (PDP)
- Develop and maintain an expert understanding of the safety profile of the assigned product(s) as well as understanding of the relevant strategic context (e.g., disease under study, safety profile of competitors, mechanism of action)
- Contribute to development the product safety strategy and provide drug safety input into the Clinical Development strategy aligned with the safety strategy and risk management plans (e.g., Integrated Safety Management Plan (ISMP), RMP)
- Review of clinical protocols, study reports, Investigator's Brochure (IB), informed consent form (ICF) and other related documents to ensure alignment with the safety strategy and ensure the appropriateness of risk management strategies and risk communication
- Contribute to regulatory authority submissions (Investigational New Drug/IND applications, New Drug Applications/NDAs, Marketing Authorization Applications/MAAs, Variations, Renewals, etc.) by reviewing safety data and preparing relevant sections of the filing and submission packages in consultation with a safety science physician
- Accountable for signal detection, evaluation and decision-making across the lifecycle of the product.
- Participate in and provide input for Drug Monitoring Committees (iDMC) or internal monitoring committee (IMC) meetings, as applicable
- Prepare and present (or support presentation) of important safety issues to the Drug Safety Committee (DSC), Development Review Committee (DRC) and other internal and external review and governance committees as needed
- Author or contribute to scientific publications (abstracts, posters, papers) for scientific meetings/journals Pharmacovigilance (PV) and Risk Management:
- Contribute to the ongoing PV and Risk Management planning for designated products by preparation of the safety surveillance strategy
- Contributes to the development and oversight of the signal detection plan (SDP) and the signal detection and assessment activities
- As assigned, support the Safety Science Leader or Director/Group Head, Safety Science or be responsible for the development of the RMP/ISMP or Risk Evaluation and Mitigation Strategies (REMS) for submission to regulatory health authorities (HA)
- Prepare and review periodic aggregate safety reports (Periodic Benefit Risk Evaluation Report/PBRER, Periodic Safety Update Report/PSUR, EU renewal and other Safety Reports) and benefit-risk assessments - Support the preparation and maintenance of safety sections of the Company Core Data Sheet and/or Reference Safety Information in the IB
Education, Skills and Experience Minimum:
- Completed MD degree and post-graduate training with 6 or more years of academic experience. Specialty training and board certification or equivalent (current or past) required (e.g., has extensive academic experience and publications and is regarded as an expert in the field), or Completed MD degree and postgraduate training with 2 or more years of clinical or academic experience and 5 or more years of drug safety, clinical development or medical affairs experience in the pharmaceutical or related industry
- Experienced leadership of cross-functional safety teams
- Demonstrated team leadership in industry or academic setting
- Experience in the principles and techniques of data analysis, interpretation and clinical relevance
- Experience publishing in a refereed journal preferred
- Understanding of GxP and regulated processes and end-to-end clinical trial lifecycle
- Strong orientation towards cross-functional teamwork
- Effectively work with remote partners on a global team
- Excellent written and verbal English communication skills
Roche is an equal opportunity employer.
Research & Development, Research & Development > Drug Safety