Johnson & Johnson Innovative Medicine
Executive Director, Therapeutic Area Safety Head, Cardiopulmonary
Johnson & Johnson Innovative Medicine, Horsham, Pennsylvania, United States, 19044
Overview
Executive Director, Therapeutic Area Safety Head, Cardiopulmonary. Location: Raritan, NJ; Titusville, NJ; or Horsham, PA. 1 week ago Be among the first 25 applicants.
Johnson & Johnson is recruiting for a Senior leadership role responsible for the oversight of the Medical Safety Officers (MSO) and Safety Analysis Scientist TA Lead (SAS TAL) within the Cardiopulmonary Therapeutic Area (CP TA) in Global Safety Strategy & Risk Management (GSSRM) in Global Medical Safety (GMS). The TA Safety Head (TASH) will oversee end-to-end medical safety strategy for products in development and on the market within the assigned TA and ensure safety activities comply with legal and regulatory requirements.
Responsibilities
Shape the safety strategy and risk management for all Johnson & Johnson Innovative Medicine (J&J IM) products during drug development and post-marketing within CP TA.
Partner 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 to proactively assess, respond to, and communicate safety concerns across the product lifecycle.
Coordinate with Clinical TA, Medical Affairs, Global Regulatory Affairs, and QPPV to implement 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 end-to-end medical safety strategy.
Attract, develop, and retain top talent; build teams to ensure organizational effectiveness, transparency, and communication.
Act ethically and responsibly to prioritize patient safety.
Lead regulatory authority interactions regarding safety and risk management for the TA, both written and verbal.
Ensure compliance of drug safety activities with global legislation and regulatory requirements.
Provide input into regulatory documents (e.g., Ad hoc reports, Health Hazard Evaluations, Clinical Overviews, PBRERS/PSURs, REMS/RMPs) and serve as the designated GMS leader on the TA Labeling Committee.
Coordinate safety topics within the TA presented to Medical Safety Council and align with other TASHs/TALs to ensure consistency across TAs.
Serve as Safety Representative on the Sponsor Committee for the Independent Data Monitoring Committee.
Provide input on licensing and acquisition of pharmaceutical medicines where applicable.
Support GSSRM Head in managing the annual budget and resource allocation to meet portfolio objectives.
Support regulatory inspection readiness, inspections, and CAPAs as relevant.
Education And Experience
Physician (MD or equivalent) with 10+ years of substantial Pharmaceutical Industry experience; clinical experience highly preferred.
Management experience supervising a team; demonstrated leadership in a global, matrix environment.
Significant skills in clinical medicine and pharmacovigilance, including post-marketing safety assessment.
In-depth knowledge of drug development principles, pharmacology, clinical trial methodology and design, medical monitoring, risk-benefit assessment, and safety assessment of drugs in development or on the market.
Proven ability to address difficult safety issues, interact with global regulatory departments/agencies, and collaborate across functions.
Ability to manage multiple critical issues, critically evaluate data from diverse sources, and assess strategic importance.
Strong influencing, negotiating, and communication skills; ability to develop and implement policy and strategy internally and externally.
Required Technical Knowledge And Skills
Excellent verbal and written communication skills; formal presentations; publication experience is desirable.
Experience presenting to technical and lay audiences at public meetings is desirable.
Knowledge of Good Clinical Practices and pharmacovigilance regulatory requirements; experience with regulatory filings, PV documents, and risk management plans.
Fluent in written and spoken English.
Working knowledge of Microsoft Office (Excel, Word).
The anticipated base pay range for this position is $226,000 to $391,000. The Company maintains competitive, performance-based compensation programs. This role is eligible for an annual performance bonus as per the applicable plan. Bonuses are discretionary and based on individual and corporate performance.
Benefits and Other Information
Medical, dental, vision, life insurance; short- and long-term disability; group legal insurance.
401(k) with company matching; long-term incentive program.
Paid time off: Vacation up to 120 hours/year; Sick time; Holidays and related time off.
Additional information available at the company benefits portal.
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 law. Reasonable accommodations available via the Careers site or AskGS.
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Johnson & Johnson is recruiting for a Senior leadership role responsible for the oversight of the Medical Safety Officers (MSO) and Safety Analysis Scientist TA Lead (SAS TAL) within the Cardiopulmonary Therapeutic Area (CP TA) in Global Safety Strategy & Risk Management (GSSRM) in Global Medical Safety (GMS). The TA Safety Head (TASH) will oversee end-to-end medical safety strategy for products in development and on the market within the assigned TA and ensure safety activities comply with legal and regulatory requirements.
Responsibilities
Shape the safety strategy and risk management for all Johnson & Johnson Innovative Medicine (J&J IM) products during drug development and post-marketing within CP TA.
Partner 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 to proactively assess, respond to, and communicate safety concerns across the product lifecycle.
Coordinate with Clinical TA, Medical Affairs, Global Regulatory Affairs, and QPPV to implement 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 end-to-end medical safety strategy.
Attract, develop, and retain top talent; build teams to ensure organizational effectiveness, transparency, and communication.
Act ethically and responsibly to prioritize patient safety.
Lead regulatory authority interactions regarding safety and risk management for the TA, both written and verbal.
Ensure compliance of drug safety activities with global legislation and regulatory requirements.
Provide input into regulatory documents (e.g., Ad hoc reports, Health Hazard Evaluations, Clinical Overviews, PBRERS/PSURs, REMS/RMPs) and serve as the designated GMS leader on the TA Labeling Committee.
Coordinate safety topics within the TA presented to Medical Safety Council and align with other TASHs/TALs to ensure consistency across TAs.
Serve as Safety Representative on the Sponsor Committee for the Independent Data Monitoring Committee.
Provide input on licensing and acquisition of pharmaceutical medicines where applicable.
Support GSSRM Head in managing the annual budget and resource allocation to meet portfolio objectives.
Support regulatory inspection readiness, inspections, and CAPAs as relevant.
Education And Experience
Physician (MD or equivalent) with 10+ years of substantial Pharmaceutical Industry experience; clinical experience highly preferred.
Management experience supervising a team; demonstrated leadership in a global, matrix environment.
Significant skills in clinical medicine and pharmacovigilance, including post-marketing safety assessment.
In-depth knowledge of drug development principles, pharmacology, clinical trial methodology and design, medical monitoring, risk-benefit assessment, and safety assessment of drugs in development or on the market.
Proven ability to address difficult safety issues, interact with global regulatory departments/agencies, and collaborate across functions.
Ability to manage multiple critical issues, critically evaluate data from diverse sources, and assess strategic importance.
Strong influencing, negotiating, and communication skills; ability to develop and implement policy and strategy internally and externally.
Required Technical Knowledge And Skills
Excellent verbal and written communication skills; formal presentations; publication experience is desirable.
Experience presenting to technical and lay audiences at public meetings is desirable.
Knowledge of Good Clinical Practices and pharmacovigilance regulatory requirements; experience with regulatory filings, PV documents, and risk management plans.
Fluent in written and spoken English.
Working knowledge of Microsoft Office (Excel, Word).
The anticipated base pay range for this position is $226,000 to $391,000. The Company maintains competitive, performance-based compensation programs. This role is eligible for an annual performance bonus as per the applicable plan. Bonuses are discretionary and based on individual and corporate performance.
Benefits and Other Information
Medical, dental, vision, life insurance; short- and long-term disability; group legal insurance.
401(k) with company matching; long-term incentive program.
Paid time off: Vacation up to 120 hours/year; Sick time; Holidays and related time off.
Additional information available at the company benefits portal.
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 law. Reasonable accommodations available via the Careers site or AskGS.
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