Join our team in a dynamic hybrid role, offering flexibility to work remotely or 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 seeking an experienced, strategic Senior Director, Toxicology to join our team. Reporting directly to the Vice President, Head of Toxicology, the successful candidate will play a pivotal role in leading nonclinical safety assessments and driving toxicology strategy across the Disc portfolio. The successful candidate will provide critical safety expertise from early-stage discovery and IND-enabling studies through to global market authorizations. The ideal candidate will also blend deep technical knowledge in nonclinical safety and pharmacokinetics with strong communication skills to cross-functionally guide programs toward clinical success.
RESPONSIBILITIES:
- Design, execute, and interpret nonclinical safety studies across all phases of drug development, including GLP toxicology, reproductive toxicology, carcinogenicity, and safety pharmacology work.
- Sound background and understanding of pharmacokinetic data to establish appropriate scientific justifications for toxicology study dose justifications and selection of safe and effective clinical doses.
- Oversight of budgets, timelines, and study monitoring and willing to visit GLP testing sites to review facilities and capabilities.
- Partner closely with clinical development, technical operations, DMPK/clinical pharmacology, discovery, and program teams to provide concise presentations on data interpretation and strategy.
- Knowledge of nonclinical regulatory frameworks and ability to draft relevant toxicology sections of regulatory documents (e.g., IND, IB, IMPD, BLA, NDA, etc.).
REQUIREMENTS:
- D. in toxicology with 10-14 years of experience overseeing toxicology programs and conducting GLP toxicology studies within the pharmaceutical industry
- Strong understanding of global toxicology guidelines, such as ICH, FDA, and EMA
- Planning and execution of IND-enabling studies to support first-in-human studies
- Planning and execution of late-stage nonclinical toxicity studies
- Strong expertise in writing and presenting nonclinical safety data within Common Technical Documents for submission to regulatory authorities (e.g., IND, NDA, MAA)
- Possesses excellent interpersonal, organizational, and communication skills
- Great collaboration and teamwork 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
PREFERRED QUALIFICATIONS:
- Experience with both large and small molecule drug development
- Experience in hematology and rare disease drug development
- D.A.B.T certification
The annual base salary range for this position is listed below. Actual pay rates are determined by considering multiple factors including qualifications, relevance of experience, education & credentials, subject matter expertise, and internal parity.
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.
Disc Medicine actively recruits individuals with an entrepreneurial spirit and a drive for excellence. Interested candidates should submit their resume to be considered for current and future opportunities.
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