Senior Principal Scientist/Principal Investigator, Drug Metabolism and Pharmacokinetics
Posted on October 24, 2025 (about 7 hours ago)
POSITION DESCRIPTION
Position Senior Principal Scientist/Principal Investigator, Drug Metabolism and Pharmacokinetics
Company Gilgamesh Pharmaceuticals
Location Remote (USA); EST-Time Zone Preferred
Company Background
Gilgamesh Pharmaceuticals is a clinical-stage neuroscience biotech with proven success following a recent $1.2B sale of their lead asset bretisilocin to AbbVie. They focus on revolutionizing psychiatric treatment through designing transformative therapies with rapid-acting and durable solutions.
Their pipeline includes blixeprodil (GM-1020), a Phase 2 oral NMDA receptor antagonist for Major Depressive Disorder, neuroplastogens partnered with AbbVie, best-in-class Ibogaine analogs, and M1/M4 agonists. They emphasize optimized molecules with precedented mechanisms balancing innovation and derisked development strategies.
Why Join Our Team Now:
- Be part of their next breakthrough
- Work at the forefront of neuroscience innovation with meaningful clinical impact
- Contribute to multiple promising programs in their diverse portfolio
- Experience a culture valuing scientific excellence and creative problem-solving
- Fully remote with periodic in-person group offsite meetings
General Description of Role:
Gilgamesh Pharmaceuticals seeks an experienced and motivated metabolism and pharmacokinetics scientist to join their rapidly growing organization. Reporting to the Head of Nonclinical Development, this senior role will provide scientific, regulatory, and strategic input on discovery and development programs through clinical development and marketing.
The ideal candidate will be an independent, critical thinker experienced in directing nonclinical development DMPK and clinical pharmacology activities across all stages of discovery and development, passionate about driving success in neuroscience and neuropsychiatry programs.
The position is fully remote with periodic full-company in-person meetings, offering competitive compensation, equity, and benefits packages.
Responsibilities:
Strategic Leadership and Program Oversight
- Serve as DMPK lead in multifunctional discovery and development project teams for optimizing compound design and development
- Design and manage nonclinical studies through external vendors to understand pharmacokinetics, pharmacodynamics, absorption, metabolism, distribution, and excretion (ADME) for novel small molecule programs
- Ensure DMPK plans align with clinical development plans and program objectives
- Oversee DMPK bioanalytical methods development and validations
- Serve as Study Monitor for DMPK studies at external partners
Regulatory Strategy and Engagement
- Author and review high-quality, scientifically-sound regulatory documents supporting clinical development and marketing authorization (e.g., pre-IND briefing documents, IND, IBs, study reports, NDAs)
- Respond to regulatory queries and represent Nonclinical Development/DMPK at global regulatory meetings
Cross-Functional Collaboration and Influence
- Provide human PK and dose projections and drug-drug interaction predictions or risk assessments
- Collaborate with pharmacology and toxicology to select preclinical species and establish PK-PD efficacy/safety relationships
- Partner with Research, Clinical Development, CMC, and Regulatory teams for seamless integration of nonclinical data
- Support dose selection, safety monitoring, and risk assessment for clinical trials
- Drive innovation in nonclinical DMPK study design leveraging emerging technologies
Leadership and Organizational Impact
- Lead the Nonclinical Development DMPK group focusing on cross-company influence, budgeting, and decision-making
- Represent Nonclinical Development/DMPK on programs, projects, initiatives, and due diligences
- Lead and mentor junior toxicologists and nonclinical operations personnel
- Manage external providers of in vitro ADME and in vivo PK services and interpret data
- Represent the company at scientific and industry conferences enhancing visibility and thought leadership
Required Qualifications:
- Ph.D. in Pharmacokinetics, Pharmaceutical Sciences, Chemistry, Biology, or related discipline with 10+ years industry experience; or M.S. with 15+ years experience
- Strong background in pharmacokinetic modeling (WinNonlin, Phoenix, NONMEM, NLME Simcyp, PK-Sim, etc.)
- Thorough understanding of drug development from discovery through marketing authorization
- Proven record authoring global regulatory submissions and interacting with global authorities
- Experience driving DMPK strategies for neuroscience and neuropsychiatry programs
- Understanding of GLP, ICH, and global regulatory requirements for DMPK studies
- Strong leadership, communication, and organizational skills; experience in fast-paced matrix environments
- CRO monitoring experience
- Forward-thinking mindset to implement innovative strategies and resolve issues
Competitive salary, equity, benefits package, and professional growth opportunities offered.
How to Apply
Please visit the original job listing on LinkedIn: Senior Principal Scientist/Principal Investigator, Drug Metabolism and Pharmacokinetics at Gilgamesh Pharma. You will need to sign in or create a LinkedIn account to apply.