Sr Manager Nonclinical Safety

Johnson & Johnson

  • Beerse, Anvers
  • CDI
  • Temps-plein
  • Il y a 23 heures
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.comJob Function:
Discovery & Pre-Clinical/Clinical DevelopmentJob Sub Function:
Nonclinical SafetyJob Category:
People LeaderAll Job Posting Locations:
Beerse, Antwerp, BelgiumJob Description: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.Learn more at https://www.jnj.com/innovative-medicineWe are searching for the best talent for a Sr. Manager Safety Pharmacology, Nonclinical Safety. Global Safety Pharmacology (GSP) sits within the Translational Sciences (TS) Group in the division of Preclinical Sciences & Translational Safety (PSTS).Essential Job Duties & Responsibilities
  • The Senior Manager is responsible for the line management of the “In Vivo Group”.
  • The candidate must have a strong interest in innovative science, drive the integration of AI into our consolidated databases and provide oversight and steer the translational/in silicol DataSciences work within Translational Safety.
  • Strong strategic analytical background, having the ability to translate preclinical datasets and processes, data acquisition and management related needs into technical solutions that align with portfolio questions.
  • This role will serve as a member of the GSP management team and provide mentorship, tutorship and career development opportunities for GSP & TS team members, where deemed necessary.
  • Provide expert scientific support to PSTS project teams as a TS representative on the team.
  • In collaboration with other preclinical safety staff members, establish and execute, upon request, local in vivo models/assays & provide global scientific advice in support of PSTS teams including oversight/monitoring of internal in vivo research activities, assuring prioritization of work targeted toward impactful portfolio contributions, keeping the 3R’s (refinement, replacement & reduction) in mind.
  • Manage the study monitors of external non-GLP CRO work and act as a study monitor, where necessary
  • Maintain awareness of the “Principles of Good Laboratory Practices (GLP)” that can/should be applied in studies, in which involved as an subject matter expert providing input to the GLP Study Monitors within Toxicology.
  • Keep updated with regulatory requirements and scientific evolutions within safety pharmacology/ general pharmacology and evolve into areas supporting changes in therapeutic area direction.
  • Works within applicable Standard Operating Procedures (SOPs) and in compliance with instructions from these documents.
  • Experience/Familiarity in FDA regulatory submissions (e.g. SEND applicable data) would be preferred.
  • Lead GSP issue resolution initiatives' in close collaboration with applicable stakeholders within preclinical safety (Toxicology & Pharmacokinetics), chemistry and discovery screening capabilities
  • Promote a collaborative, highly matrixed work environment, serving as a strategic decision-maker and serve as a change agent for global initiatives, where assigned/necessary.
  • Where possible, lead or provide guidance to internal research projects and external scientific collaborations related to safety pharmacology/general pharmacology.
  • The candidate will have a desire for continuous learning and innovation, continued career development through active participation in scientific meetings, increase visibility for self, Johnson & Johnson through publications, participation in external organizations and presentations at major scientific, industry and regulatory meetings.
  • Where asked/appropriate, participate in cross-functional PSTS strategic teams, external outreach, Johnson & Johnson leadership representative at external in vivo or regulatory forums
  • Where possible, provide adequate supervision, coaching and mentoring of post-docs and their projects.
  • Comply with expected Discovery Data Integrity (DDI) guidelines
  • Complies with Safety and Environmental Regulations and report deviations to the safety-coordinator, direct supervisor or management.
Qualifications / RequirementsEducation:
  • At minimum a PhD degree or equivalent experience in Pharmacology/Physiology (Biology, Toxicology, Veterinary, Medical or biomedical sciences), with 5+ years of postdoctoral experience within the pharmaceutical/ contract research industry.
Additionally Preferred:
  • Any certificates or demonstrated experience in the application of AI/ML in datasciences would be an advantage.
  • An understanding of drug discovery and development workflows, particularly in preclinical safety pharmacology and toxicology data, in silico prediction modeling, in vitro assays and in vivo models.
  • In the spirit of 3R’s be open minded to opportunities presented by New Alternative Models (NAM’s)
Other:
  • Strong interpersonal and organizational skills.
  • Have an open and curious attitude towards AI, Science and Innovation.
  • Excellent oral and written English communication skills.
  • Must be able to work independently with minimum supervision to meet tight deadlines and maintain a positive attitude.

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