Senior Scientist-Toxicology, Preclinical Research
The Senior Project Toxicologist has extensive experience managing contract research organizations, conducting toxicology and safety pharmacology studies in support of drug development. They develop outlines and protocols and are the key point of contact with study directors. They also serve as the Toxicology representative on cross-functional teams with respect to developing strategy and driving clinical development.
- Acts as primary scientific contact for the study director at contract research organizations.
- Monitors ongoing studies
- Contributes to CRO selection and audits
- Responsible for overseeing the progress of preclinical studies and for ensuring that the study is conducted, recorded and reported according to the study protocol and is compliant with the appropriate GLP guidance and all relevant international regulatory guidelines.
- Manages protocol development, study timelines, conduct, principal investigators and facilities to ensure study phases and sample delivery timelines are strategically overviewed and tracked.
- Responsible for the resolution of study-related issues through communication/liaison with internal/external experts in a timely manner.
- Ensures contributor reports are delivered to the CRO on time and that the CRO meets its agreed main reporting timelines.
- Reviews draft study reports and collates comments from internal/external reviewers and ensures circulation of final audited draft report through management approval/review.
- Provides study progress updates to program team members and senior management.
- Collaborates with program management and scientific leaders to identify, communicate and address preclinical challenges of drug development programs.
- MS/PhD in a scientific-related field
- 5+ years toxicology experience working within the pharmaceutical/biotechnology industry
- Hands-on experience in all aspects of toxicology study conduct including general, genetic, developmental and reproductive toxicology, carcinogenicity, toxicokinetics, and safety pharmacology
- Demonstrated knowledge of global regulatory requirements and expectations for nonclinical safety assessment packages to support first in human, clinical development, and product registration, including thorough knowledge of GLP, GCP, ICH and other applicable global guidelines
- Excellent communication and interpersonal skills, time/resource management, attention to detail, and proven success working in matrix environments
ABOUT DISC MEDICINE:
Disc Medicine is a start-up biotechnology company, formed as an Atlas Venture seed company in October of 2017 with the intent of discovering new medicines for hematological disorders with a specific focus on the discovery and development novel therapies for the treatment of hematologic diseases. Disc Medicine is led by an experienced team of scientists and industry experts and is supported by a panel of advisors with a strong track record of discovering and developing new and innovative therapies.
Disc Medicine Completed a $50 Million Series A Financing led by Novo Holdings A/S along with Access Biotechnology and founding investor Atlas Venture.
Interested in joining our team? Please contact us at firstname.lastname@example.org
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