Job Purpose:
The Medical Safety Director/Safety Director (Safety Strategy Leader, SSL) provides safety science and pharmacovigilance support to molecules across the Roche portfolio. As a group, you are responsible for all aspects of safety science/pharmacovigilance, with accountability being held by Pharma Development Safety leadership. The Medical Safety Director (MSD) or Safety Director (SD) is recognized to have strong expertise in drug safety and will be expected to work with minimal oversight and apply strong self-leadership. They will bring safety expertise to interactions with internal stakeholders, Regulatory Authorities and Data Monitoring Committees and must have the ability to interact effectively in a multifunctional and multicultural team setting. The job holder will be expected to identify areas of development and complete the required training.
As Safety Strategy Leader (SSL) you will play a leading role in shaping the strategic safety direction and planning safety strategy activities for your assigned program(s). This would include defining long-term safety-related objectives for your program(s), acting as the lead point of contact for safety for wider cross-functional leaders; owning the high-level safety program design/plan; guiding the scientific approach to the acquisition, monitoring, analysis/evaluation and communication/reporting of program-specific safety information.
Job Responsibilities:
The MSD/SD (SSL), in collaboration with Portofolio Safety Science (PSS) colleagues :
Takes the lead in defining, owning, progressing and guiding the defined safety strategy for their assigned program(s).
Is responsible for establishing and maintaining the company position on the safety profile for their program(s) and they shape the proactive patient risk communication and risk management strategy for their program. The SSL is expected to provide an objective and neutral position as a safety professional with regard to their program, even in situations where there may be conflicting business priorities or viewpoints.
Provides expert content review of the safety aspects of their specific program(s), and coordinates safety profile decision-making (e.g. IB/label updates with new safety information, updates to the ISMP/RMP) across the lifecycle of the product to ensure the safety of patients and manage clinical risk in the context of patient benefit.
Is responsible for developing and managing patient risk and communication plans, taking into account the medical value narrative, disease area landscape, comparative differentiation with competitors, and relevant data from all sources: Aiming to provide transparent, timely and meaningful information to the full range of customers, including patients, healthcare professionals and payers.
Influences key stakeholders (e.g. Triad or equivalent cross-functional development teams, Regulatory Leader, Medical Affairs & Affiliate-based counterparts, as appropriate), to ensure safety considerations are effectively taken into account and communicated/managed throughout the product life-cycle.
Is the ultimate escalation point of contact for the safety aspects (such as company position on the safety profile of the molecule, and/or the position on the company approach to clinical patient risk management) for their assigned program(s).
Develops and maintains an expert understanding of the safety profile of the assigned product(s) as well as understanding the relevant strategic context (e.g., mechanism of action, disease(s) under study, safety profile of existing standard of care in that disease area and key competitors, current and evolving market environment). This includes clear understanding of the potential mechanisms of toxicities, benefit-risk and considerations for risk management
Recommends appropriate safety monitoring measures for clinical safety issues (or potential clinical safety issues)
Provides oversight for the Core Data Sheet (CDS)/IB/label updates (including expert review) when there is a change to the safety information which impacts the safety profile; in addition is an expert reviewer for routine labelling document updates.
Informs key safety decisions at relevant governance bodies (e.g., DSC, GLAG, DRC, GVP Council, as appropriate).
Provides input (where relevant) and expert review of safety document deliverables and safety components of regulatory documents to ensure scientifically sound implementation of the safety strategy for the signal detection plan, safety reports (such as signal evaluations, drug safety reports) and safety components of regulatory documents (e.g. key sections of the DSURs/PBRERs, ISMPs/RMPs/REMS, CSRs etc).
Is responsible for designing and planning the risk management strategy for their program(s) – including measuring effectiveness of risk minimization and defining endpoints – working with scientists and members of the safety team to ensure implementation of the safety strategy.
Provides critical safety input to inform decision making by Triad/Core Team (or relevant Study/Program Team) on the design of the clinical development plan (CDP), individual studies and other program level deliverables.
Brings safety expertise to the preparation and/or conduct of interactions with Health Authorities and Data Monitoring Committees. They must have the ability to communicate clearly and interact effectively in a multifunctional and multicultural team setting.
Provides requisite oversight of regulatory authority submissions (Investigational New Drug/IND applications, New Drug Applications/NDAs, Marketing Authorization Applications/MAAs, Variations, Renewals, etc.) by providing expert review for safety documents or the safety components of other regulatory documents.
Collaborates with other internal Roche stakeholders (such as Medical Affairs and Affiliates) to ensure that relevant program level safety strategies are communicated in a timely manner and shared priorities are incorporated in Medical Affairs led/supported clinical trials and patient access programs, as needed.
Reviews safety aspects of scientific publications (abstracts, posters, papers) for scientific meetings/journals
Enable/facilitate the transition of appropriate drug candidates from Early Development Safety to Late and Mature Molecule Safety
Lead non-molecule projects, due diligence evaluations and other projects as needed.
Responsibilities for SD with medical qualifications
The MSD will provide clinical medical expertise and decision-making, in areas where this is specifically required to support colleagues in PSS.
Education, Skills and Experience
The MSD must hold a formal medical qualifications (e.g. MD; MB BS; MB ChB)andhave post-graduate experience in one or more areas of clinical medical practice.
They will preferably have experience in clinical medical practice and will typically possess 6 or more years of clinical drug development experience in the biopharmaceutical industry or a related sector (e.g. academia; CRO; etc). Preferably including at least 3 years of experience in a clinical drug safety-related role.
The SD must have a relevant postgraduate qualification (PHD in a Life sciences discipline; PharmD or other post-graduate health professional qualifications), with 6 or more years of drug development experience in the pharmaceutical or related industry including at least 3 years in drug safety
Experience in early clinical development and oncology and expected in cancer immunotherapies.
The ability to demonstrate a broad understanding of the scientific aspects of safety, PV and clinical/patient risk management (e.g. via demonstrable knowledge of the application of GVP, GCP & CTR requirements) is essential.
Demonstrated ability to lead and influence, with and without authority, in a global matrix environment.
Excellent written and verbal communication skills.
Proven success in creating and sustaining strong relationships with internal and external business partners across an organization to create positive partnerships.
Evidence of proactive, structured thinking with the ability to rapidly respond to an evolving and complex environment.
Apply complex data analysis / statistical methods to evaluate, interpret and present scientific data with clarity
Strong presentation skills, effective at summarizing and presenting the key considerations and decision points
Ability to effectively train others on departmental practices and processes
Fluent in English
Function: Pharma Development Safety (PDS)
Department: Early Safety Development (EDS)
Position type: Full time
Location: Basel
Reports to: PSS Group Leader (GL)