Johnson & Johnson Innovative Medicine
Executive Director, Therapeutic Area Safety Head, Cardiopulmonary
Johnson & Johnson Innovative Medicine, Titusville, New Jersey, us, 08560
Executive Director, Therapeutic Area Safety Head, Cardiopulmonary
Base pay range: $226,000/yr - $391,000/yr
Johnson & Johnson is recruiting for a Executive Director, Therapeutic Area Safety Head, Cardiopulmonary to be located in Raritan, NJ; Titusville, NJ or Horsham, PA.
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
The Therapeutic Area (TA) Safety Head, Johnson and Johnson Innovative Medicine (J&J IM), is responsible for the oversight of deliverables and the strategic direction of the Medical Safety Officers (MSO) and Safety Analysis Scientist TA Lead (SAS TAL) within Cardiopulmonary (CP) Therapeutic Area in Global Safety Strategy & Risk Management (GSSRM) in Global Medical Safety (GMS). The TA Safety Head (TASH) is charged with overseeing end-to-end medical safety strategy of both marketed products and products in clinical development within the assigned TA and determine the need for safety risk mitigation measures. The TASH will also maximize efficiency and effectiveness of safety-related activities by aligning around common processes, systems, and practices, and implementing new approaches to support the scientific evaluation of the safety risk profile of assigned J&J IM products. In this role, the TASH will help ensure proactive and timely assessments of safety data, understanding of the emerging and known safety profiles of products in the TA portfolio, preparation of aggregate safety reports and responses to Health Authorities (HA) and, when appropriate, communication of potential and known risks to Senior Management, HAs, Prescribers and/or Patients. The TASH maintains compliance with legal and regulatory requirements.
Responsibilities Include, But Are Not Limited To The Following
Shape the safety strategy and risk management for all J&J IM products during drug development and post-marketing within CP TA
Partner closely and effectively with the TA, the Chief Safety Officer (CSO), the Chief Medical Officer (CMO) J&J IM, the Qualified Person for Pharmacovigilance (QPPV) and other J&J IM R&D leaders and the other groups within GMS to proactively assess, respond and communicate safety concerns for products throughout the lifecycle
Connect with respective colleagues in the Clinical TA, Medical Affairs, Global Regulatory Affairs and the QPPV J&J IM for the implementation and compliance of post-marketing risk management commitments
Provide oversight, medical expertise and leadership to the TA Medical Safety Officers (MSO), SAS TAL and their direct report Scientists for the end-to-end medical safety strategy of their assigned products
Grow, attract, retain, and develop top talent, and build teams to ensure organizational effectiveness, transparency, and communication
Act ethically and responsibly to ensure patient safety is paramount
Provide leadership in regulatory authority interactions regarding safety and risk management for the TA, both written and verbal
Ensure compliance of drug safety activities and processes with global legislation and regulatory requirements
Provide input into key regulatory documents (e.g. Ad hoc reports, Health Hazard Evaluations, Clinical Overviews, PBRERS/PSURs, REMS/RMPs) and serve as the designated GMS leader and signatory on TA Labeling Committee
Coordinate safety topics within assigned TA that are presented to Medical Safety Council
In collaboration with other TASHs and TALs, ensure consistency of medical safety-related processes across TAs to ensure cohesive and coordinated approaches to best practices of clinical and post-marketing safety, working with QPPV J&J IM and other GMS functions to implement needed process improvements and maximize operational efficiencies
Serve as the Safety Representative on the Sponsor Committee for the Independent Data Monitoring Committee
Provide input on licensing and acquisition of pharmaceutical medicines
Support GSSRM Head in proactively managing of the annual budget and planned resource allocation of individuals to meet the portfolio objectives throughout the year
Support regulatory inspection readiness, inspections, and CAPAs where relevant
Education And Experience
Physician (MD or equivalent) with 10 or more years of substantial Pharmaceutical Industry experience; clinical experience highly preferred.
Management experience in supervising a group of employees; demonstrated strong CREDO values; proven leadership skills; ability to thrive in a global, matrix environment.
Significant skills in clinical medicine and pharmacovigilance, including experience in post-marketing safety assessment
Demonstrated in-depth knowledge of principles of drug development, pharmacology, clinical trial methodology and design, medical monitoring of trials, assessment of drug risks and benefits, and safety assessment of drugs both on the market and in development
Proven track record in dealing with difficult safety issues, clinical safety data, interactions with global regulatory departments / agencies, and strong collaborative and networking skills
Ability to successfully manage multiple critical issues simultaneously, critically evaluate data from multiple sources (eg, clinical trials, post-marketing environment, literature), and assess the strategic importance of the data
Ability to influence, negotiate and communicate with both internal and external customers
Ability to develop, implement, communicate and influence policy and strategy internally and externally to the company
Required Technical Knowledge And Skills
Excellent verbal and written communication skills, including formal presentation skills. Written skills as evidenced by publication and journal articles also desirable.
Experience presenting to technical and lay groups at public meetings desirable.
Knowledge of Good Clinical Practices and PV regulatory requirements, the conduct of clinical trials and for the appropriate contributions to regulatory filings, PV documents and risk management plans.
Fluent in written and spoken English
Working knowledge of the use of Microsoft suite of software products including Excel and Word
The anticipated base pay range for this position is $226,000 to $391,000. This position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. Bonuses are awarded at the Company’s discretion on an individual basis.
Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law.
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Johnson & Johnson is recruiting for a Executive Director, Therapeutic Area Safety Head, Cardiopulmonary to be located in Raritan, NJ; Titusville, NJ or Horsham, PA.
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
The Therapeutic Area (TA) Safety Head, Johnson and Johnson Innovative Medicine (J&J IM), is responsible for the oversight of deliverables and the strategic direction of the Medical Safety Officers (MSO) and Safety Analysis Scientist TA Lead (SAS TAL) within Cardiopulmonary (CP) Therapeutic Area in Global Safety Strategy & Risk Management (GSSRM) in Global Medical Safety (GMS). The TA Safety Head (TASH) is charged with overseeing end-to-end medical safety strategy of both marketed products and products in clinical development within the assigned TA and determine the need for safety risk mitigation measures. The TASH will also maximize efficiency and effectiveness of safety-related activities by aligning around common processes, systems, and practices, and implementing new approaches to support the scientific evaluation of the safety risk profile of assigned J&J IM products. In this role, the TASH will help ensure proactive and timely assessments of safety data, understanding of the emerging and known safety profiles of products in the TA portfolio, preparation of aggregate safety reports and responses to Health Authorities (HA) and, when appropriate, communication of potential and known risks to Senior Management, HAs, Prescribers and/or Patients. The TASH maintains compliance with legal and regulatory requirements.
Responsibilities Include, But Are Not Limited To The Following
Shape the safety strategy and risk management for all J&J IM products during drug development and post-marketing within CP TA
Partner closely and effectively with the TA, the Chief Safety Officer (CSO), the Chief Medical Officer (CMO) J&J IM, the Qualified Person for Pharmacovigilance (QPPV) and other J&J IM R&D leaders and the other groups within GMS to proactively assess, respond and communicate safety concerns for products throughout the lifecycle
Connect with respective colleagues in the Clinical TA, Medical Affairs, Global Regulatory Affairs and the QPPV J&J IM for the implementation and compliance of post-marketing risk management commitments
Provide oversight, medical expertise and leadership to the TA Medical Safety Officers (MSO), SAS TAL and their direct report Scientists for the end-to-end medical safety strategy of their assigned products
Grow, attract, retain, and develop top talent, and build teams to ensure organizational effectiveness, transparency, and communication
Act ethically and responsibly to ensure patient safety is paramount
Provide leadership in regulatory authority interactions regarding safety and risk management for the TA, both written and verbal
Ensure compliance of drug safety activities and processes with global legislation and regulatory requirements
Provide input into key regulatory documents (e.g. Ad hoc reports, Health Hazard Evaluations, Clinical Overviews, PBRERS/PSURs, REMS/RMPs) and serve as the designated GMS leader and signatory on TA Labeling Committee
Coordinate safety topics within assigned TA that are presented to Medical Safety Council
In collaboration with other TASHs and TALs, ensure consistency of medical safety-related processes across TAs to ensure cohesive and coordinated approaches to best practices of clinical and post-marketing safety, working with QPPV J&J IM and other GMS functions to implement needed process improvements and maximize operational efficiencies
Serve as the Safety Representative on the Sponsor Committee for the Independent Data Monitoring Committee
Provide input on licensing and acquisition of pharmaceutical medicines
Support GSSRM Head in proactively managing of the annual budget and planned resource allocation of individuals to meet the portfolio objectives throughout the year
Support regulatory inspection readiness, inspections, and CAPAs where relevant
Education And Experience
Physician (MD or equivalent) with 10 or more years of substantial Pharmaceutical Industry experience; clinical experience highly preferred.
Management experience in supervising a group of employees; demonstrated strong CREDO values; proven leadership skills; ability to thrive in a global, matrix environment.
Significant skills in clinical medicine and pharmacovigilance, including experience in post-marketing safety assessment
Demonstrated in-depth knowledge of principles of drug development, pharmacology, clinical trial methodology and design, medical monitoring of trials, assessment of drug risks and benefits, and safety assessment of drugs both on the market and in development
Proven track record in dealing with difficult safety issues, clinical safety data, interactions with global regulatory departments / agencies, and strong collaborative and networking skills
Ability to successfully manage multiple critical issues simultaneously, critically evaluate data from multiple sources (eg, clinical trials, post-marketing environment, literature), and assess the strategic importance of the data
Ability to influence, negotiate and communicate with both internal and external customers
Ability to develop, implement, communicate and influence policy and strategy internally and externally to the company
Required Technical Knowledge And Skills
Excellent verbal and written communication skills, including formal presentation skills. Written skills as evidenced by publication and journal articles also desirable.
Experience presenting to technical and lay groups at public meetings desirable.
Knowledge of Good Clinical Practices and PV regulatory requirements, the conduct of clinical trials and for the appropriate contributions to regulatory filings, PV documents and risk management plans.
Fluent in written and spoken English
Working knowledge of the use of Microsoft suite of software products including Excel and Word
The anticipated base pay range for this position is $226,000 to $391,000. This position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. Bonuses are awarded at the Company’s discretion on an individual basis.
Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law.
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