Disc Medicine is a clinical-stage biopharmaceutical company committed to discovering, developing, and commercializing novel treatments for patients who suffer from serious hematologic diseases. We are building a portfolio of innovative, first-in-class therapeutic candidates that aim to address a wide spectrum of hematologic diseases by targeting fundamental biological pathways of red blood cell biology, specifically heme biosynthesis and iron homeostasis. Disc Medicine values collaboration, professional development, and scientific integrity and promotes an inclusive company culture that empowers and inspires.
Disc Medicine is searching for a Toxicologist who will provide expertise in managing outsourced nonclinical safety studies conducted under both GLP and non-GLP conditions. The successful candidate should also have an understanding of pharmacokinetic data and appropriate justifications for dose selections. This person is expected to interact with cross-functional teams to execute nonclinical studies and work within developmental program teams to provide nonclinical safety assessments, help achieve program goals, and assist in the drafting of regulatory documents.
- Manage outsourced GLP toxicology, genotoxicity, and safety pharmacology work.
- Identify and work with CROs to oversee budgets, timelines, protocol designs, study monitoring, and drafting of study reports.
- Visit CRO testing sites to review facilities and capabilities for the conduct of GLP safety studies.
- Review, analyze, and summarize nonclinical safety data for internal presentations and regulatory filings.
- Represent toxicology at cross-functional teams to provide safety information to assist in internal decisions and regulatory filings.
- Ph.D. in toxicology or pharmacology with 4+ years of experience conducting GLP toxicology studies within the pharmaceutical industry.
- Understanding global toxicology guidelines, such as ICH, FDA, and EMA.
- Planning and execution of IND-enabling studies to support first-in-human studies.
- Has excellent interpersonal, organizational, and communication skills.
- Experience in cross-functional interactions in matrix teams.
- Track record of scientific excellence in toxicology or related scientific areas, evidenced by publications in scientific journals and/or presentations at scientific conferences.
- Experience in writing and presenting nonclinical safety data within Common Technical Documents for submission to regulatory authorities (e.g., IND, NDA, MAA).
- Experience with both small molecule and biologics drug development.
- Experience with in vitro cell-based assays supporting anti-drug antibody and/or Fc-mediator effector functional evaluations.
- Experience in hematology and rare disease drug development.
- D.A.B.T certification or currently working towards certification.
Disc Medicine is an equal opportunity employer committed to providing all qualified candidates and employees equal opportunities. We offer comprehensive benefits and competitive compensation packages. The Company headquarters are in Watertown, MA, and we provide a flexible work environment.