Job Description
SUMMARY:
This position is responsible for the design, execution and interpretation of nonclinical safety and clinical pharmacology studies that are required to support the progression of therapies from late discovery, through first in human and proof of concept clinical studies.
RESPONSIBILITIES:
- Identify, map out and manage internally or externally all nonclinical and translational studies (including drug metabolism, pharmacokinetics and toxicology) that are required for compounds as they move from discovery through development
- Communicate proactively the status and issues of programs to upper management and program teams
- Review and interpret data, develop protocols and review and finalize reports
- Contribute to CRO selection and qualification
- Participate in budgeting
- Participate in due diligence activities
- Work with discovery and clinical teams to integrate activities and set forth appropriate strategies.
- Author nonclinical toxicology, DMPK and biomarker sections of regulatory documents
REQUIREMENTS:
- Ph.D. Pharmacology, Biochemistry, Toxicology or any other relevant field
- At least 7 years of experience in the biopharmaceutical industry
- In depth understanding of the regulatory requirements for nonclinical studies that support registration as well as the disciplines that conduct those studies
- Past hands on experience with drug metabolism and pharmacokinetics studies
- Expertise in nonclinical toxicology
- Solid understanding of drug metabolism, bioanalysis, pharmacokinetics and clinical pharmacology study design, as well as translational biomarkers
- Expertise managing CROs, GLP and regulatory guidelines
- Excellent communication and interpersonal skills, and proven success working in matrix environments
ABOUT DISC MEDICINE:
Disc Medicine is a biopharmaceutical company dedicated to the discovery and development of novel therapies to transform the lives of patients who suffer from hematologic diseases. Disc Medicine is led by an experienced team of scientists and industry experts and completed a $50 Million Series A financing in October 2019 led by Novo Holdings A/S along with Access Biotechnology and founding investor Atlas Venture.
