Associate Director/Director Drug Metabolism and Pharmacokinetic (DMPK)
Day One was founded to address a critical unmet need: children with cancer are being left behind in a cancer drug development revolution. Our name was inspired by the “The Day One Talk” that physicians have with patients and their families about an initial cancer diagnosis and treatment plan. We aim to re-envision cancer drug development and redefine what’s possible for all people living with cancer—regardless of age—starting from Day One.SUMMARY:Day One Biopharmaceuticals is seeking an exceptional individual and scientist to lead our Drug Metabolism and Pharmacokinetic (DMPK) activities. The successful candidate will develop scientific strategies, engage teammates across functions, and build partnerships in order to advance Day One’s research and clinical development stage programs. The Director of DMPK will oversee the quality and performance of all DMPK and ADME activities including interactions with CROs and internal project stakeholders. This individual will represent their function on study and project teams, participate in regulatory interactions, and be the internal subject matter expert for this crucial aspect of drug development. ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Lead the scientific, technical, and operational initiation and execution of DMPK efforts across drug discovery and development programs.Lead the preclinical assessment of ADME properties, including metabolism and routes of elimination for lead candidates.Manage bioanalytical needs across research and clinical development programs.Manage DMPK activities, including routine studies and be responsible for all DMPK and ADME deliverables.Manage consultants and CROs including selection and implementation. Define and assign resources and budget to all projects.Drive framework for pediatric and adult clinical dose projections and dose selection for Phase 1 and subsequent clinical trialsSupport clinical pharmacology trial design based on DDI risk analysis and nonclinical data.Create the vision for DMPK and ADME at Day One and design our long-term strategic and operational model to support our growing research and development portfolio.Participate and author regulatory documents, including relevant sections of INDs, IBs, and other regulatory documentsResolve highly complex business and scientific problems through excellent scientific judgment and broad research, development, and regulatory affairs knowledge.
- Ph.D. in Pharmaceuticals Sciences, Pharmacokinetics, Drug Metabolism or a related field with 10+ years of experience in biotech/pharmaceutical discovery and development
ORMS with 15+ years of experience in biotech/pharmaceutical discovery and development
- Demonstrated track record and expertise in DMPK, ADME, PK/PD, as well as biotransformation and metabolite identification and characterization studies.Comprehensive understanding and scientific knowledge of DMPK/ADME, PK/PD and drug development processes, including dose selection for clinical studies that support the characterization of safety and efficacy of oncology therapeutics.Experience managing CRO, consultants, and budgets.Excellent oral and written communication skills, the ability to work as an effective team member in highly collaborative work environment, and the ability to lead and influence.Well-versed in health authority guidance and strategies to support global drug development.