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.
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
- 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
- Contribute to the strategy and review of safety assessments and drug safety reports for signals or issues (product quality) or in response to HA requests
- May be expected to support non-molecule projects, due diligence evaluations and other projects as needed.
- Will work in partnership with CSSD team members to meet Safety Science deliverables
- Consistently complies with all governing laws, regulations, Roche Standard Operating Procedures and other guidelines.
- Contribute and/or lead the development of the safety components of the Target Product Profile (TPP), key claims and other lifecycle strategic planning documents (e.g., the Clinical Development Plan/CDP, Integrated Development and Commercialisation Process/IDCP, etc.). Responsible for the safety components and co-responsibility for the benefit/risk components together with the Clinical representative
- Develop and maintain comprehensive product safety strategy
- Contribute to the CDP throughout the exploratory and confirmatory phase together with the Clinical representative in order to optimise the benefit/risk profile
- Accountable for the safety components of study reports, aggregate reports and high level regulatory documents
- Acquire and contribute knowledge of relevant drug class and/or competitor safety issues. Lead development of the safety surveillance strategy, identify potential clinical safety issues and recommend appropriate safety monitoring measures
- Lead the development of scientific publications (abstracts, posters, papers) for scientific meetings/journals and approve the submissions from a safety perspective
- Enable/facilitate the transition of appropriate drug candidates from exploratory to confirmatory development for all aspects pertinent to safety. Assume similar responsibilities for the transition of products from LCT stage to mature stage when there are no longer any global clinical development activities nor any significant clinical development
- Able to manage multiple and/or complex programs
- Experienced leadership of cross-functional safety teams
- Mentor new group members
- Lead internal projects and represent PDS at expert forums (e.g., CIOMS, etc)
- Medical interpretation of emerging clinical safety data for signal detection and signal evaluation purposes, and to determine the medical significance of any findings
- Determining the causal relationship of events for Individual Case Safety Reports (ICSRs) when the task resides in PDS
- Defining the safety question or issue requiring medical safety assessment
- Reviewing and approving (i.e., signatory) for drug safety reports, PBRER/PSUR and other aggregate reports
- Performing medical impact assessments for product quality issues
- Determining medical impact of nonclinical safety findings
- Reviewing and approving (if needed) clinical protocols to ensure medical appropriateness of safety relevant sections such as inclusion/exclusion criteria, safety monitoring and management, and schedule of assessments.
- Providing medical interpretation of whether/how risks impact the overall risk-benefit balance