Job Description
Who we are
At Roche, 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity, and on seeing each other’s differences as an advantage. To innovate healthcare, Roche has ambitious plans to keep learning and growing – and is seeking people who have the same goals for themselves.
The Position
The Safety Science Leader (SSL) is accountable for all aspects of safety related to a product in LCT stage or a group of products in early exploratory phase or mature, including single case assessment, aggregate reporting, signal detection, risk management throughout the life cycle.
The Safety Science Leader leads product specific safety analyses including medical evaluation, risk management, signal detection using epidemiology and other input as appropriate. Part of the accountability is exerted by bringing the safety topics to the Clinical Team and when appropriate to the Life Cycle Team in order to ensure that adequate measures based on safety findings are taken and also implement the CIOMS 6 recommendation of a cross-functional team including preclinical, pharmacology, clinical development, strategic marketing, biometrics…, With the CSL and GRL, they focus on characterizing the benefit/risk of the product and ensure the safety and longevity of their products throughout their development and commercial lifecycle.
The Safety Science Leader maintains an Integrated Safety Management Plan (ISMP) throughout the life cycle of the product or medicine and is accountable for the safety component of the Early Development Plan/IDCP, study protocols and reports, data evaluation and clinical NDA / BLA preparation as well as various periodic safety reports. in order to optimize the benefit/risk profile and communicate it clearly.
The SSL represents Safety Science in the Life Cycle Team (LCT), Clinical Team (CT) and Early Research and Development teams (DBPTs) as a core member. The SSL contributes to the appropriate design of the clinical development plan throughout the development of the product and enabling / facilitating the transition of appropriate drug candidates from exploratory to confirmatory development for all aspects pertinent to safety. Likewise they are responsible for the transition from LCT stage to Mature stage when there are no longer any global clinical development activities nor significant galenic development.
The SSL leads the Safety Team (essentially internal to PDS) including as appropriate the various experts such as: safety scientists, safety operation physician, epidemiologist, medical writer, statistics, safety licensing manager,
In contributing to the development of the TPP, the key claims and other life cycle strategic planning documents (eg PDP, IDCP, …) the SSL is responsible for the safety components and co-responsible for the benefit/risk components together with the TML/CSL • Contributes to the development of the clinical development plan throughout the exploratory and confirmatory phase together with the TML/CSL in order to optimize the benefit/risk ratio
• The SSL is responsible for the safety components of the clinical study protocols. For studies that are performed under the responsibility of Medical Affairs in Head Office or in the Affiliates, the SSL is responsible for the minimal safety standard that should be implemented, the IML is responsible for the implementation
• The SSL is accountable for the safety components of the study reports , aggregate reports and high level regulatory documents
• Supports the clinical and life cycle teams in bringing the safety expertise in interaction with Health Authorities, Data Safety Monitoring Boards and Investigators
• Acquires and contributes knowledge of relevant drug class and/or competitor safety issues
• Initiate (in phase 0) and maintain the Integrated Safety Management Plan (ISMP) throughout the life cycle and ensure PSURs are of high quality and produced in a timely manner
• Contributes to the timely submissions of the presentations to the NC-DSC together with Toxicology and other members of the team
• Is responsible for the submissions and the presentations to the DSC in a timely fashion and ensures high quality presentations
• contributions to IND/CTAs, clinical study reports, annual safety reports, project plans, project documents and presentations
• Contributes to the scientific publications (abstracts, posters, papers) for scientific meetings/journals and approves the submissions from a safety perspective
• Review all communication to the public from a safety point of view
• Keeps EU QPPV fully informed of any changes to benefit -risk, and where appropriate performs tasks as delegated by the EU QPPV.
During Exploratory Phase Development• In DBPT, the SSL exerts the role of "Translational safety medicine leader"
• Perform the Due Diligence activities and provide the drug safety input in a timely manner
During Confirmatory, NDA and Commercialization Stages• With the CSL and the CT, plans and performs, on an ongoing basis, an evaluation of the safety data to detect safety signals . On an ongoing basis with the team, evaluates the Benefit/risk ratio of the program and how to manage patients within and across trials.
• Accountable for the safety components of all NDA documents
• Is responsible for the writing of the RMP/REMS NDA documents and their maintenance
• Represents Roche in interaction with Health Authorities and Independent Data Safety Monitoring Boards (ie Pre-BLA/NDA meetings, advisory committees) for safety related topics.
• Contributes to and where specifically delegated may be responsible for the proper execution of the post-approval RMP/REMS
• Ensures that all safety processes are properly supported and documented for all studies conducted by PD or PB or affiliates
During the Mature phase • Responsible for the Safety Science management of a portfolio of mature products
• Ensures that all safety processes are properly supported (pharmacovigilance, signal detection, risk management, benefit/risk)
• Ensures the proper execution of relevant RMP/REMS. Accountable for the proper execution of RMP / REMS tactics when they are delegated to other parties inside or outside the company
• Is responsible for the submissions to the NC-DSC and DSC in a timely fashion (including when rapid response is needed) and ensures high quality presentations.
• Responsible for the maintenance of the CDS and for issues unrelated to safety (which are relevant to DSC) approves the changes after review and discussion with Strategic Marketing and Regulatory Affairs
People Leadership : • Provides provide leadership and line management to the Safety Sciences department across multiple locations, aligning with other parts of the organization where necessary
• Ensure that the performance of direct reports is proactively managed and they are coached, trained and developed in order to maximize their contribution.
• Allocates resources and is accountable for the assignment of his/her collaborators / reports according to their individual capabilities and in line with the projects priorities
• Ensures that staff communication and employee relations are managed proactively to maximise the well being of the employees.
• Actively installs the Roche values in the safety team and their activities.
Contribution to PDS:• Identifies future needs for resources and identifies, recruits, trains and develops appropriate talent. Selects, interviews and makes recruitment recommendations in the reporting area. Contributes to development and maintenance of job and role descriptions, competency frameworks and development plans to meet current and future business needs of the function.
• Contributes to continuing improvement of PDS processes and systems
Who you are
You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies, and where a job title is not considered the final definition of who you are, but the starting point.
Education/Qualifications: Minimum:
Physician who would be eligible for medical practice in EU or in US Strongly desired:
MD and PhD
Post doctorate experience in a specialty like internal medicine, pediatrics, geriatrics is highly valued
Experience, Skills, Knowledge: • Previous experience in the pharmaceutical industry (preferably including safety but may be in clinical development or medical affairs).
• Significant period of time in clinical practice
• Significant experience of drug development including the evaluation and interpretation of scientific and clinical data.
• Demonstrated knowledge of Safety Science across a breadth of therapeutic areas particularly in relation to issue management and signal detection and evaluation.
• Solid knowledge and understanding of US and EU pharmacovigilance regulatory requirements and general regulatory expectations
• Proven experience in proactively leading a team of individuals located across a number of sites and in leading them to optimize their performance and contribution. Proven ability to coach and develop people.
• Demonstrated experience of proactively driving a variety of tasks and projects and delegating to a team. Able to manage budget and timelines.
• Fluent in verbal and written English
• Strong written and verbal communication skills to a variety of levels and teams, internally and externally. Demonstrated persuasion, influencing and negotiation skills.
• Ability to operate objectively and independently as a leader and as a member of a team, as required
• Ability to interact effectively in a multifunctional and multicultural team setting (Safety team, Clinical team, Life Cycle Team)
• Ability to interact with Health Authorities as the primary contact person for safety aspects in face to face meetings
• Computer literacy and familiarity with relevant software and systems
Additional Information:
§ The SSL leads a multifunctional safety team (size and complexity depends on the stage of the product)
§ In the Early phase (before LCT stage) the safety team includes safety scientists, safety operations and epidemiology
§ In LCT stage, the safety team may include one or more safety specialists (direct reports), safety operations, epidemiology, advanced analytics, signal detection expert, risk management/benefit-risk manager, medical writing, communication
§ In Mature stage, the safety team includes safety operations, epidemiology, signal detection, risk mgt/benefit-risk manager
§ The SSL strongly influences the development program and post-approval commitments to accommodate safety related requirements
§ The SSL works alongside the Toxicologist, theTML and the members of Clinical Research and Exploratory Development to evaluate the relevance of preclinical data and is responsible for assuring alignment of development objectives for the molecule between Exploratory Development (represented by the TMS) and Clinical Development for all aspects pertinent to safety
Background or experience in Virology a plus.
The next step is yours. To apply today, click on the "Apply online" button below.
Roche is an Equal Opportunity Employer
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