Overseeing non-clinical activities and safety assessments for Organon’s R&D programs. Managing scientists and ensuring compliance with regulatory requirements in drug development.
Responsibilities
Lead all aspects of non-clinical safety assessment for pipeline programs
Management and oversight of Non-Clinical Development (NCD) project representatives
Serve as a subject matter expert and an effective technical and strategic leader
Engage and communicate effectively with regulators, scientific leaders, and physicians
Support Drug Safety and Pharmacovigilance with activities such as review of non-clinical literature
Requirements
PhD, DVM or equivalent degree in pharmacology, biology, physiology, biochemistry, chemistry, toxicology or related sciences
Board certification in toxicology preferred (e.g., DABT, ERT)
A minimum of 15 years of non-clinical drug development experience in the pharmaceutical or biotech industry
Extensive and in-depth knowledge background in toxicology
Demonstrated expertise in non-clinical safety assessment and toxicology is required
Experience with additional modalities is preferred (eg, peptides, antibodies, gene or cell therapies, or drug-device combinations)
Excellent organizational and interpersonal skills
Benefits
retirement savings plan
paid vacation and holiday time
paid caregiver/parental and medical leave
health benefits including medical, prescription drug, dental, and vision coverage
Job title
Executive Director – Non-Clinical Safety Assessment Lead
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