Principal Scientist, DMPK

As the Senior Scientist II DMPK, you will support and lead nonclinical development DMPK activities to support progression of muscle directed potential treatment for diseases characterized by compromised muscle function, muscle weakness, and fatigue. You will collaborate closely with IND enabling project teams; develop and execute DMPK and PKPD strategies necessary to optimize and facilitate the advancement of muscle-directed small molecules into Clinical Development.

Responsibilities

• Lead the formulation and execution of comprehensive DMPK and pharmacokinetics-pharmacodynamics (PKPD) strategies to steer lead optimization and developmental projects, ensuring alignment with project objectives, milestones, and progression of development candidates
• Act as the primary DMPK and bioanalytical representative within project teams, contributing expertise to the advancement of innovative drug candidates, encompassing both small molecules and potentially large molecules such as PROTACs, targeted at addressing Cardiovascular and Skeletal Muscle diseases
• Employ sophisticated analysis and synthesis techniques to integrate in silico, physicochemical, ADME, and DMPK data, with a keen focus on understanding the intricate dynamics of drug metabolism and potential drug-drug interactions, thereby informing molecule design and selection processes
• Collaborate seamlessly with cross-functional project team members spanning Biology, Chemistry, translational Pharmacology, toxicology, and Regulatory affairs, facilitating the generation of pertinent DMPK data essential for informed decision-making, including target validation, biomarker selection, and candidate progression
• Engage actively in partnership with key stakeholders to contribute to the development of robust PK/PD models, aimed at furnishing critical insights and data supporting effective translational and biomarker strategies
• Lead the coordination and oversight of Drug Metabolism, PK, and PKPD studies, encompassing the solicitation of bioanalytical support
• Contribute to the preparation of Drug Metabolism, PK, and PKPD reports, including active involvement in report writing, review, and preparation, with a particular emphasis on crafting DMPK-BA sections of regulatory documents such as Investigational New Drug (IND), New Drug Application (NDA), and Biologics License Application (BLA), as well as providing comprehensive responses to regulatory inquiries, thereby ensuring the generation of high-quality reports aligned with regulatory standards and expectations

Qualifications

• Doctorate (PhD) with 8+ years of experience Pharmaceutical Sciences or related field
• In-vivo and in-vitro drug metabolism including mass balance, stability evaluation, structural elucidation, enzymology, drug-drug interaction (DDI), metabolic enzyme inhibition and induction
• Experience conducting and implementing bioanalysis (BA) methodology in the ADME, PK and PD areas (regulated and non-regulated)
• Proficiency in applying pharmacokinetic (PK) principles to both noncompartmental and compartmental analysis within PK/TK/PD studies
• Proficient understanding and application of cytochrome enzyme inhibition, induction, drug transporter functionality, and their effects on pharmacokinetics (PK) and drug-drug interactions (DDI)
• Expertise in in-vitro - in-vivo extrapolations (IVIVE) and allometric principles, with a focus on utilizing these methods for accurate predictions of first-in-human dose and exposure
• Knowledgeable of current regulatory landscape in DMPK area of expertise including contribution to regulatory filings (IND, NDA, investigator brochure)