Managing Partner leading Healthcare Media strategies at Dentsu. Overseeing client development and integrated communication in Frankfurt or München.
About the role
- Non-Clinical Safety Assessment Representative overseeing toxicology for asset development teams at Organon. Engaging in cross-functional development and regulatory submissions with emphasis on safety assessments.
Responsibilities
- Serves as the Non-Clinical Safety Assessment (toxicology) representative on interdisciplinary asset development teams (ADTs)
- Plans and executes non-clinical safety studies and assessments at appropriate stages to support asset progression through development and to meet project timelines
- Serving as the subject matter expert in the non-clinical field in meetings with internal/external stakeholders
- Author and review of non-clinical CTD modules for regulatory submission (e.g., IND, NDA), briefing books, or other regulatory communications
- Provide scientific and strategic non-clinical safety (toxicological) input into Organon’s pipeline programs
- Serve as a subject matter expert and/or provide technical area expertise for non-clinical development issues
- Coordinate non-clinical pharmacology and toxicology studies at Contract Research Organizations (CROs)
- Ensure that non-clinical studies are conducted in compliance with relevant regulations, guidelines, and animal welfare standards
- Author or review the non-clinical, early clinical development or CMC documentation
Requirements
- PhD, DVM or equivalent degree in pharmacology, biology, physiology, biochemistry, chemistry, toxicology or related sciences
- Board certification in toxicology a plus (e.g., DABT, ERT)
- A minimum of five to seven years of experience in the pharmaceutical or biotech industry with extensive and in-depth knowledge of non-clinical safety assessment and drug development
- Strong background in toxicology with competency in DMPK and pharmacology
- Demonstrated knowledge of non-clinical development as well as drug substance and drug product impurity-related regulatory guidelines and GxP requirements
- Experience with review and authoring non-clinical sections of regulatory dossiers (e.g., NDAs) and product labels with first-hand experience with agency interactions
- Experience in working in project teams (preferably global project teams)
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
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