What are the responsibilities and job description for the Director, Toxicology position at Disc Medicine?
Join our team in a dynamic hybrid role, offering flexibility to work remotely and from our headquarters in Watertown, MA.
COMPANY OVERVIEW:
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.
POSITION OVERVIEW:
Disc Medicine is searching for a Director of Toxicology. The successful candidate 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.
RESPONSIBILITIES:
Disc Medicine actively recruits individuals with an entrepreneurial spirit and a drive for excellence. Interested candidates should submit a cover letter and resume to be considered for current and future opportunities.
COMPANY OVERVIEW:
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.
POSITION OVERVIEW:
Disc Medicine is searching for a Director of Toxicology. The successful candidate 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.
RESPONSIBILITIES:
- Manage outsourced GLP toxicology and safety pharmacology work
- Identify and work with CROs to oversee budgets, timelines, protocol designs, study monitoring, and drafting of study reports
- Visit GLP testing sites to review facilities and capabilities for the conduct of studies
- Review, analyze, and summarize nonclinical safety data for internal presentations and regulatory filings
- Draft relevant toxicology sections of regulatory documents (e.g., IND, IB, IMPD, BLA, NDA, etc.)
- 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 10 years of experience conducting GLP toxicology studies within the pharmaceutical industry
- Understanding global toxicology guidelines, such as ICH, FDA, and EMA
- At least 5 years of experience with monoclonal antibody drug development
- Planning and execution of IND-enabling studies to support first-in-human studies
- Planning and execution of late-stage nonclinical toxicity studies
- Experience in writing and presenting nonclinical safety data within Common Technical Documents for submission to regulatory authorities (e.g., IND, NDA, MAA)
- 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 with large and small molecules in both early- and late-stage drug development
- Experience in hematology and rare disease drug development
- D.A.B.T certification
Disc Medicine actively recruits individuals with an entrepreneurial spirit and a drive for excellence. Interested candidates should submit a cover letter and resume to be considered for current and future opportunities.
