Director, Global Medical Safety at Kiniksa Pharmaceuticals
Lexington, MA 02420
About the Job
Reporting to the VP, Global Medical Safety (GMS), this individual will be responsible for leading and working collaboratively to assess, track and document the ongoing benefit-risk profile of all marketed products and those in development
This includes contributing to the safety sections of numerous aggregate reports (e.g., DSUR, PBRER, ASR), coordinating cross functional Safety Review Team (SRT) meetings, ensuring the completion of signal detection activities, and directing appropriate resource to all clinical development and product registration activities
This role is based in our Lexington office
Our office-based employees follow a hybrid schedule of 4 days in the office, and 1 day remote.Responsibilities (including, but not limited to):Interact across multiple functions, lead the GMS operational activities and support senior levels of the organizationSafety Review Team meetings, and Signal Detection Activities:Ensure delivery of the technical and scientific support for safety surveillance and signal detection activities for assigned products via established signal detection methodology and tools
Evaluate signals promptly in signal detection reports and ad-hoc responses to regulatory authorities in collaboration with GMS Medical leadEfficiently plan Internal Safety Review Committee (SRC) and Safety Review Team (SRT) meetings, ensuring that stakeholders provide input from their respective areas of responsibility.Contribute to safety sections of Risk Management Plans (RMPs) and other appropriate Regulatory process driven documents, if needed – ensuring that “safety sections” are completed and consulted upon. Support for investigational products and registration activities: Effectively collaborate with stakeholders outside of GMS.Represent GMS department in cross-functional clinical programs and registrational activities and provide GMS support for clinical developmental programs.Aggregate report production:Oversee coordination and contribution to the production of periodic and ad-hoc safety reporting for therapeutic team products. Create safety content and coordinates, with Regulatory Affairs and Medical Writing, the completion of aggregate reports (e.g
PBRER, DSUR, PADER, as well as ad hoc queries or reports) for submission to regulatory agencies.Collaborates with the Vice President and Medical Lead to ensure that all information is available to allow for informed medical review and benefit-risk assessment. Responsible for the quality of the safety sections of relevant final document and providing an overall review.Support clinical development products in early stage (P1 and P2):Work with clinical development stakeholders to develop early-stage trial designMay act as a manager for a product or group of products
Oversee and assume responsibility for assigned therapeutic products and PV activities through the lifecycle of the product
May include review of compliance in PV function and/or working directly with Kiniksa compliance staff.Qualifications:Requires a bachelor’s degree in Life Sciences or Healthcare (Advanced degree, PharmD preferred)10+ years work experience with relevant experience in Safety/PharmacovigilanceExperience in the support of development products OR equivalent for drug product candidates in research settings Good understanding of drug pharmacology strongly preferred.Understanding of the clinical development and relevant regulatory processPractical experience in the interpretation of global Pharmacovigilance regulations and implementation within an industry setting preferred
Alternatively demonstrate interchangeable skillset in healthcare related fieldCompetence in conducting safety data reviews for investigational and/or post marketed products or equivalent experience in healthcare or research setting.Ability to contribute to and review standard operating procedures and other process-related documentsExcellent communication, collaboration and networking skillsAbility to influence others within a matrix environmentMust be able to work in a fast-paced environment with demonstrated ability to simultaneously manage multiple competing tasks and demandsAbility to work independently, take initiative and complete tasks to deadlinesForward planning and proactiveSupport global decision-making and direction setting, including devising of future strategy and the management of complex tasksStrong commitment to compliance and ethical standardsProficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)Salary is commensurate with experienceKiniksa Benefits Summary - USAKiniksa is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, transgender status, age, genetics, national origin, protected veteran status, or disability status, or any other legally protected category
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment
Please contact us to request accommodation.
This includes contributing to the safety sections of numerous aggregate reports (e.g., DSUR, PBRER, ASR), coordinating cross functional Safety Review Team (SRT) meetings, ensuring the completion of signal detection activities, and directing appropriate resource to all clinical development and product registration activities
This role is based in our Lexington office
Our office-based employees follow a hybrid schedule of 4 days in the office, and 1 day remote.Responsibilities (including, but not limited to):Interact across multiple functions, lead the GMS operational activities and support senior levels of the organizationSafety Review Team meetings, and Signal Detection Activities:Ensure delivery of the technical and scientific support for safety surveillance and signal detection activities for assigned products via established signal detection methodology and tools
Evaluate signals promptly in signal detection reports and ad-hoc responses to regulatory authorities in collaboration with GMS Medical leadEfficiently plan Internal Safety Review Committee (SRC) and Safety Review Team (SRT) meetings, ensuring that stakeholders provide input from their respective areas of responsibility.Contribute to safety sections of Risk Management Plans (RMPs) and other appropriate Regulatory process driven documents, if needed – ensuring that “safety sections” are completed and consulted upon. Support for investigational products and registration activities: Effectively collaborate with stakeholders outside of GMS.Represent GMS department in cross-functional clinical programs and registrational activities and provide GMS support for clinical developmental programs.Aggregate report production:Oversee coordination and contribution to the production of periodic and ad-hoc safety reporting for therapeutic team products. Create safety content and coordinates, with Regulatory Affairs and Medical Writing, the completion of aggregate reports (e.g
PBRER, DSUR, PADER, as well as ad hoc queries or reports) for submission to regulatory agencies.Collaborates with the Vice President and Medical Lead to ensure that all information is available to allow for informed medical review and benefit-risk assessment. Responsible for the quality of the safety sections of relevant final document and providing an overall review.Support clinical development products in early stage (P1 and P2):Work with clinical development stakeholders to develop early-stage trial designMay act as a manager for a product or group of products
Oversee and assume responsibility for assigned therapeutic products and PV activities through the lifecycle of the product
May include review of compliance in PV function and/or working directly with Kiniksa compliance staff.Qualifications:Requires a bachelor’s degree in Life Sciences or Healthcare (Advanced degree, PharmD preferred)10+ years work experience with relevant experience in Safety/PharmacovigilanceExperience in the support of development products OR equivalent for drug product candidates in research settings Good understanding of drug pharmacology strongly preferred.Understanding of the clinical development and relevant regulatory processPractical experience in the interpretation of global Pharmacovigilance regulations and implementation within an industry setting preferred
Alternatively demonstrate interchangeable skillset in healthcare related fieldCompetence in conducting safety data reviews for investigational and/or post marketed products or equivalent experience in healthcare or research setting.Ability to contribute to and review standard operating procedures and other process-related documentsExcellent communication, collaboration and networking skillsAbility to influence others within a matrix environmentMust be able to work in a fast-paced environment with demonstrated ability to simultaneously manage multiple competing tasks and demandsAbility to work independently, take initiative and complete tasks to deadlinesForward planning and proactiveSupport global decision-making and direction setting, including devising of future strategy and the management of complex tasksStrong commitment to compliance and ethical standardsProficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)Salary is commensurate with experienceKiniksa Benefits Summary - USAKiniksa is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, transgender status, age, genetics, national origin, protected veteran status, or disability status, or any other legally protected category
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment
Please contact us to request accommodation.
