This position will be temporarily based in Nutley, NJ and will move to the Translational Clinical Research Center (TCRC) in New York City upon the opening of the facility.
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, …
Primary Responsibilities and Accountabilities
Across all phases of the life cycle:
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.
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.
elects, interviews and makes recruitment recommendations in the reporting area. Minimum Qualifications:
Physician who would be eligible for medical practice in EU or in US and a significant period of time in clinical practice
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 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
Roche is on a medicinal roll. The company operates two segments, pharmaceuticals and diagnostics, and sells its products in some 180...