Job Purpose: The Safety Science Leader (SSL) is accountable for all safety related aspects of a product in LCT stage or a group of products in the early exploratory phase or mature stage, including but not limited to single case assessment, aggregate reporting, integrated signal prediction/detection (ISP/ISD), integrated risk management process (ISMP) & comparative benefit risk (in collaboration with Clinical Science and Regulatory) throughout the life cycle.
Primary Responsibilities and Accountabilities
Roche Leadership Commitments: Embrace the Roche Leadership Commitments: a. Take a genuine interest in people; b. Listen carefully, tell the truth, and explain the why; c. Empower and trust people to make decisions; d. Discover and develop the potential in people; e. Strive for excellence and extraordinary results; f. Set priorities and simplify work; g. Congratulate people for a job well done.
Across all phases of the life cycle: The SSL represents Safety Science in the Life Cycle Team (LCT), Global Development Team (GDT) and Research and Early Development teams (RED teams) as a core member.
In contributing to the development of the TPP, the key claims and other life cycle strategic planning documents (eg CDP, IDCP) the SSL is responsible for the safety components and co-responsible for the benefit/risk components together with the Clinical representative (from REDs in LEAD & PDC for LCT-clusters)
Contributes to the clinical development plan (CDP) throughout the exploratory and confirmatory phase together with the Clinical representative in order to optimize the benefit/risk profile
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 ensuring the inclusion of minimal safety standards 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, RED 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. Provides safety strategy, identify potential clinical safety issues and recommends appropriate safety monitoring measures.
Initiate (in phase 0) and maintain the Integrated Safety Management Plan (ISMP) throughout the life cycle and ensure Periodic Safety Update Reports (PSURs) are of high quality and produced in a timely manner
Contributes to the timely & quality submissions of the presentations to the gDRC (gRED) or NC-DSC (pRED) together with Toxicology and other members of the team
Contributes to the timely & quality submissions of the presentations to the DRC
Is responsible for the submissions and the presentations to the Drug Safety Committee (DSC), ensures that important safety issues are brought up to the DSC in a timely fashion and ensures high quality presentations
Contributes 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
Strategic contribution to the development of key safety messages for internal communications and reviews 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.
The SSL enables / facilitates the transition of appropriate drug candidates from exploratory to confirmatory development for all aspects pertinent to safety. Likewise they are responsible for the transition of products from LCT stage to mature stage when there are no longer any global clinical development activities nor any significant galenic development.
During Exploratory Phase Development (REDs)
In the RED teams, the SSL exerts the role of “Translational safety medicine leader”
Perform assigned Due Diligence activities and provide the drug safety input in a timely manner
Creates and maintains the ISMP and the ISP/ISD plan and their execution
The SSL liaises with pre-clinical safety , toxicology and clinical pharmacology to develop implications of animal findings to man
During Confirmatory, NDA and Commercialization Stages
The SSL leads the cross-functional Life Cycle Safety Team (as sub-team to the GDT) including as appropriate the various experts such as: clinical science leader, global regulatory leader, international medical leader, safety scientists, safety operation physician, epidemiologist, medical writer, statistician,
With the CSL , the Clinical Team (CT) and Global Regulatory Lead (GRL),, plans and performs, on an ongoing basis, evaluation of the safety data to detect safety signals. On an ongoing basis with the team, evaluates the comparative benefit/risk profile of the product and how to manage and ensure patient safety within and across trials.
The Safety Science Leader leads product specific safety analyses through leading a cross-functional Life Cycle Safety Team. Part of the accountability is exerted by bringing the safety topics to the GDT (Global Development Team) and when appropriate to the Life Cycle Team in order to ensure that adequate measures based on safety findings are taken and also to implement the CIOMS 6 recommendation of a cross-functional team including preclinical, pharmacology, clinical development, regulatory, strategic marketing, biometrics, medical affairs and publication representation (as applicable).
Maintains the ISMP and the ISP/ISD plan and their execution
Accountable for the safety components of all New Drug Application (NDA) documents. As a key member of the filing team (FT), contributes towards preparation of important regulatory documents including but not limited to, the clinical overview, integrated summary of Safety (ISS) and briefing package. Responsible for the creation and maintenance of the product Core Data Sheet (CDS) and for issues related to safety, support implementation of required changes after review and discussion with the Global Labelling Committee (GLC)
Contributes to the writing of the RMP/REMS NDA documents and their maintenance
Represents Roche in interaction with Health Authorities and Independent Data Safety Monitoring Boards (i.e., 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 Development, Medical Affairs 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 assessment)
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
Leads the cross-functional Safety Team (a sub-team of the GDT)
Provides 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 maximize 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
Professional and Technical Requirements: Education/Qualifications
Minimum: Physician who would be eligible for medical practice in EU or in US (or equivalent such as Switzerland, Australia, Canada, New Zealand,), PharmD or PhD Degree Required
Strongly desired: MD Preferred
Experience, Skills, Knowledge:
Previous experience in the pharmaceutical industry (preferably including safety but may be in clinical development , toxicology or medical affairs).
Significant period of time in clinical practice
Significant experience of drug discovery or 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 managing 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, Global Development 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
Travel Requirements: Availability to travel nationally and internationally
Who We Are
A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry
for more than 40 years, using human genetic information to develop novel medicines for serious and
life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious
illnesses. Please take this opportunity to learn about Genentech where we believe that our employees
are our most important asset & are dedicated to remaining a great place to work.
The next step is yours. To apply today, click on the "Apply online" button.
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