Brief Description:

The Senior Principal Statistician, Biostatistics will be a lead statistician on individual studies, across related studies, and for integrated summaries and will design and report Phase I to IV clinical studies and regulatory filings under the supervision of a more senior statistician.  This role is responsible for all statistical aspects of study design, study analysis and validation, and study documentation.  The Senior Principal Statistician will provide timely and scientifically sound statistical expertise to clinical development projects and develop and execute statistical strategy, design, and analyses for clinical trials. This position will work collaboratively with clinical development, pharmacology, pharmacovigilance, clinical drug supply, project management, regulatory affairs, medical writing, clinical data management, and clinical operations.  The Senior Principal Statistician will manage work done by statistics and programming external vendors.

Essential Functions

• Participate in department and cross-functional meetings to optimize clinical study designs, endpoints, and analysis strategies in protocols.
• Collaborate with cross-functional team members to meet study any recurring report timelines.
• Support the development and implementation of study protocols.
• Review and provide input to data capture systems and participate in their validation.
• Develop statistical programs as necessary to simulate clinical trial design operating characteristics, perform analysis, prepare data displays, verify data accuracy and validity of analyses performed by statistical programming.
• Write statistical analysis plans, review statistical analysis plans written by other statisticians, perform and oversee data analysis and validation, and interpret analyses.
• Prepare for and attend meetings with regulatory agencies.
• Work with biostatistics compound/therapeutic area lead, peer management, and employees to develop, implement, and maintain department standards and practices.
• Review timelines and analysis plans for CRO work to ensure timeliness and quality deliveries.

• Review and validate CRO deliverables.
• Act as the statistical subject matter expert with medical writers and other colleagues in the production of clinical reports, integrated summaries, and other documents.
• Respond to statistical questions from regulatory agencies.

Required Knowledge, Skills, and Abilities

• Knowledge of clinical trial design and analysis, including experience with complex statistical methods and models, including statistical principles and methodology and principles of statistical inference, including hypothesis testing and deriving estimates, parametric and non-parametric models and techniques, principles of sample size calculations for comparing two arms, principles of design of experiments in introducing conditions designed to affect an outcome of interest, and phase II-IV clinical trial data analysis.
• Experience in using SAS and R; knowledge of other statistical applications and programming languages a plus.
• Knowledge of applicable regulatory requirements and guidelines, e.g., ICH Guidelines and drug development regulatory requirements as they relate to statistics, including statistical contributions to marketing applications and CDISC standards.
• Able to work in a fast-paced, flexible, team-oriented environment.
• Possess excellent interpersonal and communication skills (written and verbal).
• Strong attention to detail with a view to bring studies to a quality conclusion.
• Flexible, positive, creative thinker, good communicator.
• Work without close supervision. Well-developed time management skills are important.

Required/Preferred Education and Licenses

• MS or MPH in statistics, mathematics, or a related discipline with a statistical focus and > 4 years of experience in pharmaceutical or biotechnology industry.
• PhD in statistics, mathematics, or a related discipline with a statistical focus and > 2 years of experience in the pharmaceutical or biotechnology industry.
• Knowledge of drug development regulations pertinent to statistical analysis.
• Knowledge of the oncology or hematology therapeutic area is preferred
• Bayesian and adaptive design experience is preferred.
• Proficient SAS & R programming skills, solid understanding of CDISC models and standards.
• Excellent writing and communication skills, demonstrated leadership abilities and excellent interpersonal skills.

 #LI-Remote  

Brief Description

• This individual will be responsible for leading scientific team members assigned to oncology assets ranging from discovery through regulatory approval.

• This individual will both manage the oncology pharmacology team and serve a lead on one or more programs themselves.

• Primary responsibilities of the oncology pharmacology team include establishing efficacy in relevant disease models, demonstrating differentiation relative to relevant comparators, determining PK/PD/efficacy relationships, characterizing mechanisms of action, identifying predictive disease models, indications, and biomarkers, driving preclinical discovery, supporting research and development of Jazz products and drug candidates overall, and designing and executing studies that address clinically relevant priorities.

• Operational tasks include designing and executing experiments that are outsourced or performed by in-house bench researchers or academic collaborators, reviewing and contributing to clinical protocols, reviewing and authoring technical reports, coauthoring sections of regulatory documents ranging from IND to NDA/BLA submissions, and communicating relevant research at internal and external forums.

• The oncology pharmacology team cross-functional, including participation in matrix teams assigned to specific products that include but are not limited to Clinical Development, Bioanalytical, Toxicology, Clinical Pharmacology, Biomarkers Regulatory Affairs, and Project Management.  

• Collaborate with and represent ORP on internal teams—to design, develop, implement, and oversee execution of strategies and experiments supporting nonclinical studies in hematologic malignancies and solid tumors.

Essential Functions

• Design and execute experiments to elucidate efficacy, tolerability, mechanism of action, and biomarkers associated with complex combinations of multiple therapeutic modalities (small molecules, biologics, ADCs, bi-specifics, cell therapies, and other emerging platforms).

• Critically evaluate biochemical and cellular assays.

• Communicate effectively across JAZZ functional teams, highly matrixed, cross functional environments.

• Demonstrate strong interpersonal, negotiation, and influence skills.

• Independently develop experimental strategies, analyze data, and present results to non‑clinical and governance-level teams.

• Collaborate with CROs to outsource studies, develop protocols, manage timelines and budgets, and partner with academic labs for Jazz sponsored research.

• Serve as a project team leader and/or as lead pharmacology representative across various oncology programs,

• Mentor junior scientists and providing scientific leadership and professional growth opportunities.

 Required Knowledge, Skills, and Abilities

• Industry experience evaluating therapeutic potential of drug candidates from hit to lead optimization through IND enabling studies, with deep expertise in oncology drug development.

• Broad background in preclinical oncology with strong familiarity with emerging therapeutic modalities, competitive landscapes, and strategic assessment of diverse drug mechanisms.

• Extensive experience in Immuno Oncology (I/O), including I/O relevant in vivo and in vitro models, immune cell biology, and integration of immunological endpoints into pharmacology programs.

• Demonstrated experience working across multiple drug modalities, including small molecules, biologics, ADCs, bi-specifics, T cell engagers, cell and gene therapies, and RNA based therapeutics.

• Strong foundational understanding of the interdependencies between Nonclinical Pharmacology, Toxicology, DMPK, and Clinical Pharmacology, including how these functions integrate to enable successful dose selection, therapeutic index characterization, risk assessment, and translational strategy.

• Deep understanding of cancer signaling pathways and their therapeutic exploitation.

• Proven experience leading multiple complex pharmacology programs at diverse CROs, including GLP and non-GLP environments.

• Expertise designing and executing studies evaluating efficacy, tolerability, mechanism of action, and biomarker strategies for small molecule and biologic agents.

• Ability to integrate preclinical and clinical datasets, innovate, and apply novel methodologies to advance therapeutic programs.

• Proficiency with analytical tools (e.g., GraphPad Prism) and biomarker data analysis.

• Direct people management experience, including mentorship, performance development, and leadership of scientific teams.

• Strong leadership qualities, self motivation, and demonstrated success networking across internal teams, academia, industry, and regulatory agencies.

• Excellent ability to assess program needs, oversee CRO activities, develop/review protocols, monitor execution, interpret results, and prepare high quality reports for regulatory submissions.

• Experience authoring nonclinical components of IND, NDA/BLA/MAA submissions, briefing packages, DSURs, IBs, and fast track designation documents, with proven ability to ensure alignment and scientific rigor.

• Strong project management skills with the ability to manage multiple complex programs simultaneously.

• Demonstrated success leading in fast paced, highly matrixed environments, aligning diverse stakeholders and driving decision making.

• Strong analytical and creative problem-solving skills.

• Embody and model Jazz core values.

Required/Preferred Education and Licenses

• Ph.D. in biology, biochemistry, immunology, pharmacology, or a related discipline, with experience leading early oncology programs  and developing nonclinical models for characterizing therapeutic efficacy and pharmacodynamics, including substantial oncology and immuno-oncology experience.

#LI-SM1

#LI-remote

Brief Description:

The Global Safety Physician serves as the safety expert accountable for the global safety strategy and overall safety profile for Jazz Pharmaceuticals product/s (investigational and marketed) throughout their lifecycle. This includes supporting major pre- and post-marketing safety deliverables including signal, benefit-risk evaluation and risk management activities for specific products. This individual must effectively interface cross-functionally at all levels in the organization as well as with external Regulatory Authorities. This individual will work together with PV management to ensure the safety assessment of priority product/s, including review of aggregate safety analyses and scientific literature, preparing safety reports and communicating changes in the product risk profile to internal and external stakeholders. The ability to work in a dynamic, changing environment to meet corporate and patient needs is essential.

Essential Functions

Job Responsibilities and Requirements:

• Lead the preparation and review of safety-related section(s) for product/s. Documents include review of specific clinical, regulatory, and scientific documents including protocols, informed consent/assent forms, case report forms (CRFs), statistical plans, clinical study reports/synopses, integrated summaries of safety, New Drug or Biologic License Applications (NDA/BLA), Marketing Authorization Applications (MAA), Common Technical Document (CTD) submissions, Regulatory Agency responses, IRB/EC requests, briefing books, manuscripts/journal articles and other documents as needed, ensuring safety profile reflected for assigned product/s.

• Be a key member, as the safety representative, to a Global Regulatory Team and to a Core Development Team.

• Interface with Risk Evaluation and Mitigation Strategy (REMS) team to optimize risk management of assigned products from a PV perspective.

• Where relevant, support creation and maintenance of Company Core Safety Information (CCSI) and ensure implementation of CCSI in all Reference Safety Information (RSI) including Investigator Brochures (IBs), Company Core Data Sheet (CCDS), national labels and other associated product labeling.

• Support review of medical/scientific literature to identify literature relevant for signal detection activities and aggregate reporting for assigned product/s, as needed.

• Support signal detection activities to ensure signal identification, evaluation, validation, for assigned product including individual and aggregate data analyses; interpretation of safety signals and trends; documentation and communication of safety assessments (written and verbal) of safety risks in collaboration with CRSO and PV management.

• Participate in or Lead a Safety Management Team (SMT) for an assigned product.

• Contribute to the preparation and review of pre- and post- marketing aggregate safety reports IND Annual Reports, and 6-monthly Suspected Unexpected Serious Adverse Reactions (SUSARs) Line Listing Reports and ensure consistent communication of safety profile/topics across various regulatory safety documents for assigned product/s.

• Contribute to preparation of Risk Management Plans (RMPs) for assigned products ensuring identification of risks, appropriate risk minimization and effectiveness measures in accord with regulatory requirements.

• Provide guidance with adverse event (MedDRA) and drug (WHO Drug) coding for clinical and postmarketing safety data.

• Demonstrate or gain knowledge of current and applicable global PV regulations and guidelines (e.g., CIOMS, EMA, FDA, ICH, etc.), SOPs and quality standards.

• Provide safety expertise to due diligence activities, if/ as needed.

• Keeps abreast of new PV/safety regulations and guidance from the regulatory authorities.

Required Knowledge, Skills, and Abilities

Minimum Requirements

• Minimum 2-5 years of Clinical Development, Medical Affairs or Drug Safety/Pharmacovigilance experience; other relevant medical affairs experience may be considered.

• Excellent knowledge of drug development process.

• Requires a high level of initiative and independence.

• Must have excellent written and oral communication skills, resourcefulness and personal organization skills together with demonstrated cross-functional teamwork.

• Computer literacy with proficiency in external Regulatory Databases, Microsoft Excel, PowerPoint and Word.

• Some national/international travel may be required.

Leadership Skills

• Enterprise and Proactive Mindset—demonstrate collaborative spirit, understanding the benefit of working with others cross functionally, in a dynamic environment.

• Set & Achieve Goals: Understand business objectives and effectively translate them into strategies, while skillfully navigating obstacles and resistance to change.

• Inspire & Mobilize Others: Serve as a positive role model – create followership and effectively mobilize and influence others, both on your teams and across the organization.

• Understanding of target product profile; clinical designs and/or global PV regulatory environment with working knowledge of international regulations, initiatives, standards and Good Clinical and Pharmacovigilance practices (GCP, GVP).

• Exposure to working relationship with the FDA, EMA and other regulatory authorities is preferred.

• Working knowledge of safety databases (ARISg, ARGUS, or other safety database applications) and electronic data capture systems a plus.

• MedDRA trained and working knowledge of MedDRA and WHO Drug coding dictionaries a plus.

• Ability to manage multiple tasks with deadlines in fast-pace environment.

Required/Preferred Education and Licenses

• MD required; medical licensure in at least one region preferred; clinical research and/or fellowship training in internal medicine, oncology, neurology, or other relevant specialty is a plus.

#LI-Remote      

Brief Description

• This individual will be responsible for leading scientific team members assigned to oncology assets ranging from discovery through regulatory approval.

• This individual will both manage the oncology pharmacology team and serve a lead on one or more programs themselves.

• Primary responsibilities of the oncology pharmacology team include establishing efficacy in relevant disease models, demonstrating differentiation relative to relevant comparators, determining PK/PD/efficacy relationships, characterizing mechanisms of action, identifying predictive disease models, indications, and biomarkers, driving preclinical discovery, supporting research and development of Jazz products and drug candidates overall, and designing and executing studies that address clinically relevant priorities.

• Operational tasks include designing and executing experiments that are outsourced or performed by in-house bench researchers or academic collaborators, reviewing and contributing to clinical protocols, reviewing and authoring technical reports, coauthoring sections of regulatory documents ranging from IND to NDA/BLA submissions, and communicating relevant research at internal and external forums.

• The oncology pharmacology team cross-functional, including participation in matrix teams assigned to specific products that include but are not limited to Clinical Development, Bioanalytical, Toxicology, Clinical Pharmacology, Biomarkers Regulatory Affairs, and Project Management.  

• Collaborate with and represent ORP on internal teams—to design, develop, implement, and oversee execution of strategies and experiments supporting nonclinical studies in hematologic malignancies and solid tumors.

Essential Functions

• Design and execute experiments to elucidate efficacy, tolerability, mechanism of action, and biomarkers associated with complex combinations of multiple therapeutic modalities (small molecules, biologics, ADCs, bi-specifics, cell therapies, and other emerging platforms).

• Critically evaluate biochemical and cellular assays.

• Communicate effectively across JAZZ functional teams, highly matrixed, cross functional environments.

• Demonstrate strong interpersonal, negotiation, and influence skills.

• Independently develop experimental strategies, analyze data, and present results to non‑clinical and governance-level teams.

• Collaborate with CROs to outsource studies, develop protocols, manage timelines and budgets, and partner with academic labs for Jazz sponsored research.

• Serve as a project team leader and/or as lead pharmacology representative across various oncology programs,

• Mentor junior scientists and providing scientific leadership and professional growth opportunities.

 Required Knowledge, Skills, and Abilities

• Industry experience evaluating therapeutic potential of drug candidates from hit to lead optimization through IND enabling studies, with deep expertise in oncology drug development.

• Broad background in preclinical oncology with strong familiarity with emerging therapeutic modalities, competitive landscapes, and strategic assessment of diverse drug mechanisms.

• Extensive experience in Immuno Oncology (I/O), including I/O relevant in vivo and in vitro models, immune cell biology, and integration of immunological endpoints into pharmacology programs.

• Demonstrated experience working across multiple drug modalities, including small molecules, biologics, ADCs, bi-specifics, T cell engagers, cell and gene therapies, and RNA based therapeutics.

• Strong foundational understanding of the interdependencies between Nonclinical Pharmacology, Toxicology, DMPK, and Clinical Pharmacology, including how these functions integrate to enable successful dose selection, therapeutic index characterization, risk assessment, and translational strategy.

• Deep understanding of cancer signaling pathways and their therapeutic exploitation.

• Proven experience leading multiple complex pharmacology programs at diverse CROs, including GLP and non-GLP environments.

• Expertise designing and executing studies evaluating efficacy, tolerability, mechanism of action, and biomarker strategies for small molecule and biologic agents.

• Ability to integrate preclinical and clinical datasets, innovate, and apply novel methodologies to advance therapeutic programs.

• Proficiency with analytical tools (e.g., GraphPad Prism) and biomarker data analysis.

• Direct people management experience, including mentorship, performance development, and leadership of scientific teams.

• Strong leadership qualities, self motivation, and demonstrated success networking across internal teams, academia, industry, and regulatory agencies.

• Excellent ability to assess program needs, oversee CRO activities, develop/review protocols, monitor execution, interpret results, and prepare high quality reports for regulatory submissions.

• Experience authoring nonclinical components of IND, NDA/BLA/MAA submissions, briefing packages, DSURs, IBs, and fast track designation documents, with proven ability to ensure alignment and scientific rigor.

• Strong project management skills with the ability to manage multiple complex programs simultaneously.

• Demonstrated success leading in fast paced, highly matrixed environments, aligning diverse stakeholders and driving decision making.

• Strong analytical and creative problem-solving skills.

• Embody and model Jazz core values.

Required/Preferred Education and Licenses

• Ph.D. in biology, biochemistry, immunology, pharmacology, or a related discipline, with experience leading early oncology programs  and developing nonclinical models for characterizing therapeutic efficacy and pharmacodynamics, including substantial oncology and immuno-oncology experience.

#LI-SM1

#LI-remote

Brief Description:

The Senior Principal Statistician, Biostatistics will be a lead statistician on individual studies, across related studies, and for integrated summaries and will design and report Phase I to IV clinical studies and regulatory filings under the supervision of a more senior statistician.  This role is responsible for all statistical aspects of study design, study analysis and validation, and study documentation.  The Senior Principal Statistician will provide timely and scientifically sound statistical expertise to clinical development projects and develop and execute statistical strategy, design, and analyses for clinical trials. This position will work collaboratively with clinical development, pharmacology, pharmacovigilance, clinical drug supply, project management, regulatory affairs, medical writing, clinical data management, and clinical operations.  The Senior Principal Statistician will manage work done by statistics and programming external vendors.

Essential Functions

• Participate in department and cross-functional meetings to optimize clinical study designs, endpoints, and analysis strategies in protocols.
• Collaborate with cross-functional team members to meet study any recurring report timelines.
• Support the development and implementation of study protocols.
• Review and provide input to data capture systems and participate in their validation.
• Develop statistical programs as necessary to simulate clinical trial design operating characteristics, perform analysis, prepare data displays, verify data accuracy and validity of analyses performed by statistical programming.
• Write statistical analysis plans, review statistical analysis plans written by other statisticians, perform and oversee data analysis and validation, and interpret analyses.
• Prepare for and attend meetings with regulatory agencies.
• Work with biostatistics compound/therapeutic area lead, peer management, and employees to develop, implement, and maintain department standards and practices.
• Review timelines and analysis plans for CRO work to ensure timeliness and quality deliveries.

• Review and validate CRO deliverables.
• Act as the statistical subject matter expert with medical writers and other colleagues in the production of clinical reports, integrated summaries, and other documents.
• Respond to statistical questions from regulatory agencies.

Required Knowledge, Skills, and Abilities

• Knowledge of clinical trial design and analysis, including experience with complex statistical methods and models, including statistical principles and methodology and principles of statistical inference, including hypothesis testing and deriving estimates, parametric and non-parametric models and techniques, principles of sample size calculations for comparing two arms, principles of design of experiments in introducing conditions designed to affect an outcome of interest, and phase II-IV clinical trial data analysis.
• Experience in using SAS and R; knowledge of other statistical applications and programming languages a plus.
• Knowledge of applicable regulatory requirements and guidelines, e.g., ICH Guidelines and drug development regulatory requirements as they relate to statistics, including statistical contributions to marketing applications and CDISC standards.
• Able to work in a fast-paced, flexible, team-oriented environment.
• Possess excellent interpersonal and communication skills (written and verbal).
• Strong attention to detail with a view to bring studies to a quality conclusion.
• Flexible, positive, creative thinker, good communicator.
• Work without close supervision. Well-developed time management skills are important.

Required/Preferred Education and Licenses

• MS or MPH in statistics, mathematics, or a related discipline with a statistical focus and > 4 years of experience in pharmaceutical or biotechnology industry.
• PhD in statistics, mathematics, or a related discipline with a statistical focus and > 2 years of experience in the pharmaceutical or biotechnology industry.
• Knowledge of drug development regulations pertinent to statistical analysis.
• Knowledge of the oncology or hematology therapeutic area is preferred
• Bayesian and adaptive design experience is preferred.
• Proficient SAS & R programming skills, solid understanding of CDISC models and standards.
• Excellent writing and communication skills, demonstrated leadership abilities and excellent interpersonal skills.

 #LI-Remote  

Brief Description:

The Global Safety Physician serves as the safety expert accountable for the global safety strategy and overall safety profile for Jazz Pharmaceuticals product/s (investigational and marketed) throughout their lifecycle. This includes supporting major pre- and post-marketing safety deliverables including signal, benefit-risk evaluation and risk management activities for specific products. This individual must effectively interface cross-functionally at all levels in the organization as well as with external Regulatory Authorities. This individual will work together with PV management to ensure the safety assessment of priority product/s, including review of aggregate safety analyses and scientific literature, preparing safety reports and communicating changes in the product risk profile to internal and external stakeholders. The ability to work in a dynamic, changing environment to meet corporate and patient needs is essential.

Essential Functions

Job Responsibilities and Requirements:

• Lead the preparation and review of safety-related section(s) for product/s. Documents include review of specific clinical, regulatory, and scientific documents including protocols, informed consent/assent forms, case report forms (CRFs), statistical plans, clinical study reports/synopses, integrated summaries of safety, New Drug or Biologic License Applications (NDA/BLA), Marketing Authorization Applications (MAA), Common Technical Document (CTD) submissions, Regulatory Agency responses, IRB/EC requests, briefing books, manuscripts/journal articles and other documents as needed, ensuring safety profile reflected for assigned product/s.

• Be a key member, as the safety representative, to a Global Regulatory Team and to a Core Development Team.

• Interface with Risk Evaluation and Mitigation Strategy (REMS) team to optimize risk management of assigned products from a PV perspective.

• Where relevant, support creation and maintenance of Company Core Safety Information (CCSI) and ensure implementation of CCSI in all Reference Safety Information (RSI) including Investigator Brochures (IBs), Company Core Data Sheet (CCDS), national labels and other associated product labeling.

• Support review of medical/scientific literature to identify literature relevant for signal detection activities and aggregate reporting for assigned product/s, as needed.

• Support signal detection activities to ensure signal identification, evaluation, validation, for assigned product including individual and aggregate data analyses; interpretation of safety signals and trends; documentation and communication of safety assessments (written and verbal) of safety risks in collaboration with CRSO and PV management.

• Participate in or Lead a Safety Management Team (SMT) for an assigned product.

• Contribute to the preparation and review of pre- and post- marketing aggregate safety reports IND Annual Reports, and 6-monthly Suspected Unexpected Serious Adverse Reactions (SUSARs) Line Listing Reports and ensure consistent communication of safety profile/topics across various regulatory safety documents for assigned product/s.

• Contribute to preparation of Risk Management Plans (RMPs) for assigned products ensuring identification of risks, appropriate risk minimization and effectiveness measures in accord with regulatory requirements.

• Provide guidance with adverse event (MedDRA) and drug (WHO Drug) coding for clinical and postmarketing safety data.

• Demonstrate or gain knowledge of current and applicable global PV regulations and guidelines (e.g., CIOMS, EMA, FDA, ICH, etc.), SOPs and quality standards.

• Provide safety expertise to due diligence activities, if/ as needed.

• Keeps abreast of new PV/safety regulations and guidance from the regulatory authorities.

Required Knowledge, Skills, and Abilities

Minimum Requirements

• Minimum 2-5 years of Clinical Development, Medical Affairs or Drug Safety/Pharmacovigilance experience; other relevant medical affairs experience may be considered.

• Excellent knowledge of drug development process.

• Requires a high level of initiative and independence.

• Must have excellent written and oral communication skills, resourcefulness and personal organization skills together with demonstrated cross-functional teamwork.

• Computer literacy with proficiency in external Regulatory Databases, Microsoft Excel, PowerPoint and Word.

• Some national/international travel may be required.

Leadership Skills

• Enterprise and Proactive Mindset—demonstrate collaborative spirit, understanding the benefit of working with others cross functionally, in a dynamic environment.

• Set & Achieve Goals: Understand business objectives and effectively translate them into strategies, while skillfully navigating obstacles and resistance to change.

• Inspire & Mobilize Others: Serve as a positive role model – create followership and effectively mobilize and influence others, both on your teams and across the organization.

• Understanding of target product profile; clinical designs and/or global PV regulatory environment with working knowledge of international regulations, initiatives, standards and Good Clinical and Pharmacovigilance practices (GCP, GVP).

• Exposure to working relationship with the FDA, EMA and other regulatory authorities is preferred.

• Working knowledge of safety databases (ARISg, ARGUS, or other safety database applications) and electronic data capture systems a plus.

• MedDRA trained and working knowledge of MedDRA and WHO Drug coding dictionaries a plus.

• Ability to manage multiple tasks with deadlines in fast-pace environment.

Required/Preferred Education and Licenses

• MD required; medical licensure in at least one region preferred; clinical research and/or fellowship training in internal medicine, oncology, neurology, or other relevant specialty is a plus.

#LI-Remote      

The Associate Medical Director / Global Safety Physician is responsible for implementing the global safety strategy and monitoring the overall safety profile for Jazz Pharmaceuticals products (investigational and marketed) throughout its lifecycle. This includes generating all major pre- and post-marketing safety deliverables including signal, benefit-risk evaluation and risk management activities. This individual must effectively interface cross-functionally at all levels in the organization as well as with external Regulatory Authorities. This individual, under supervision from the Senior Medical Director in Medical Safety, will work together with PV staff in managing the safety assessment of products, including review of aggregate safety analyses and scientific literature, preparing safety reports and communicating changes in the product risk profile to internal and external stakeholders. The ability to work in a dynamic, changing environment to meet corporate and patient needs is essential.

•  Provide Medical Safety/PV inputs to the assigned products at Jazz Pharmaceuticals, which may include Clinical Development program of all phases, Investigator

Sponsored, Compassionate Use, and Disease Monitoring Programs; liaise with Clinical Sciences, Clinical Operations, Medical Affairs, Biometrics, Regulatory Affairs, Contract Research Organizations (CROs), Data Monitoring Committees (DMCs) and other entities to contribute to overall study execution while ensuring safety strategy and operational excellence

•  Provide Medical safety/PV inputs to Jazz Pharmaceuticals Commercial organization to support global launch activities for assigned products

•  Participate in the preparation and review of safety-related section(s) for clinical, regulatory, and scientific documents including protocols, informed consent/assent forms, case report forms (CRFs), statistical plans, clinical study reports/synopses, integrated summaries of safety, New Drug or Biologic License Applications (NDA/BLA), Marketing Authorization Applications (MAA), Common Technical Document (CTD) submissions, Regulatory Agency responses, IRB/EC requests, briefing books, manuscripts, journal articles and other documents as needed, ensuring safety profile reflected for assigned products

•  Collaborate in the creation and maintenance of Company Core Safety Information (CCSI) and with the Jazz Labeling Committee ensure implementation of CCSI in all Reference Safety Information (RSI) including Investigator Brochures (IBs), Company Core Data Sheet (CCDS), national labels and other associated product labeling

•  Perform review of medical/scientific literature to identify literature relevant for signal detection activities and aggregate reporting for assigned products, as needed

•  Conduct signal detection activities to ensure signal identification, evaluation, validation, for assigned products including individual and aggregate data analyses; interpretation of safety signals and trends; documentation and communication of safety assessments (written and verbal) of safety risks in collaboration with key internal/external stakeholders

•  Chair the Safety Management Team (SMT) of products under authority and participate in other executive forums for assigned products

•  Serve as the signatory and overseer of the preparation and review of pre- and postmarketing aggregate safety reports including Periodic Safety Update Reports (PSURs)/Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Reports (DSURs), IND Annual Reports, and 6-month Suspected Unexpected Serious Adverse Reactions (SUSARs) Line Listing Reports and ensure consistent communication of safety profile/topics across various regulatory safety documents for assigned products

•  Contribute to preparation of Risk Management Plans (RMPs) for assigned products ensuring identification of risks, appropriate risk minimization and effectiveness measures in accord with regulatory requirements

•  Provide guidance with adverse event (MedDRA) and drug (WHODrug) coding for clinical and post-marketing safety data

•  Demonstrate knowledge and ensure compliance with current and applicable global PV regulations and guidelines (e.g., CIOMS, EMA, FDA, ICH, etc.), SOPs and quality standards; active involvement in inspection readiness activities, internal audits and external inspections

•  Represent PV in cross-functional forums and committees involving products under responsibility to achieve the Company’s goals

•  Contribute to key performance indicators to ensure PV excellence

•  Maintain knowledge of Jazz Pharmaceuticals indications for investigational and/or marketed products assigned

•  Keeps abreast of new PV/safety regulations and guidance from the regulatory authorities

•  Understanding of global PV regulatory environment with working knowledge of international regulations, initiatives, standards and Good Pharmacovigilance practices (GVP) including but not limited to Americas and European Union, territories including an understanding of case processing procedures and other pharmacovigilance processes

•  Working knowledge of safety databases (ARISg, ARGUS, or other safety database applications) and electronic data capture systems

•  MedDRA trained and working knowledge of MedDRA and WHO Drug coding dictionaries

•  Working experience with PV audit process with active participation in Regulatory Authority Inspections is preferred

•  Ability to manage multiple tasks with deadlines in fast-paced working environment

•  Knowledge of drug development process

•  Requires a high level of initiative and independence

•  Must have excellent written and oral communication skills, resourcefulness and personal organization skills together with demonstrated cross-functional teamwork

•  Computer literacy with proficiency in external Regulatory Databases, Microsoft Excel, PowerPoint and Word

•  Some national/international travel may be required

•       MD required (or equivalent); medical licensure in at least one state preferred; clinical research and/or fellowship training in internal medicine or neuroscience, hematology/oncology or other relevant specialty is a plus

•       Minimum 3 years of Drug Safety/Pharmacovigilance (PV) experience or 3 or more years clinical development experience. Other relevant experience may be considered

#LI-Remote