USASr. Principal Scientist / Director, DMPK & Bioanalytical Sciences
1 мес. назад
USADirector
dmpkbioanalyticalmethod developmentpk study designbiomarker strategyglpgcpregulatory filings
Lead DMPK and bioanalytical strategy across nonclinical and clinical programs in a clinical-stage biotech environment.
Обязанности
- Lead DMPK and bioanalytical strategy across nonclinical and clinical programs, including PK, biomarker, and translational PD readouts
- Lead method development, qualification, and validation for bioanalytical assays (GLP/GCP-compliant as required)
- Design, execute, and oversee PK and PK-PD studies of tRNAs to evaluate delivery technologies (LNP and others) and biomarker effects
- Manage and qualify CRO and external lab partners across bioanalytical and PK programs
- Support nonclinical toxicology programs in collaboration with internal teams and CROs
- Analyze, interpret, and present DMPK and translational biomarker data to internal leadership and external stakeholders
- Author nonclinical sections of regulatory filings (e.g., IND) and briefing documents; support agency interactions and responses
- Serve on the Research Leadership Team; represent DMPK and bioanalytical sciences in cross-functional program discussions
- Manage and develop direct report(s); collaborate with the broader pharmacology team
Требования
- PhD or equivalent in pharmacokinetics, pharmacology, biochemistry, analytical chemistry, or related field
- 8+ years of industry experience in DMPK, bioanalytical sciences, or closely related function
- Experience with a range of bioanalytical methods and their development, qualification, and validation in both nonclinical and clinical contexts (e.g. mass spectroscopy, ELISA, NGS, etc.)
- Experience with ligand binding assays and multiplex immunoassay platforms (e.g., MSD, Luminex) for cytokine, immunogenicity, and biomarker analysis
- Demonstrated CRO oversight - vendor qualification, study monitoring, data review
- Experience designing and overseeing PK and PK-PD studies for novel delivery modalities; LNP experience preferred
- Experience in translational or clinical biomarker development, including assay strategy and fit-for-purpose qualification
- Strong scientific writing skills - regulatory documents (e.g., IND nonclinical sections) and internal study reports
- Experience supervising and developing scientists
Будет плюсом
- Experience in rare disease, genetic medicine, or nucleic acid / RNA therapeutics
- Familiarity with LNP platform biology and delivery landscape
- Familiarity with GLP toxicology study design and ICH nonclinical guidelines
- Experience operating in a cross-functional leadership role at a clinical-stage biotech
- Experience with LC-MS/MS or related mass spectrometry platforms
Другое
- Reporting to the Chief Scientific Officer, this role leads DMPK and bioanalytical strategy across nonclinical and clinical programs, operating as a hands-on scientific leader. We are looking for an accomplished DMPK and bioanalytical scientist with experience in PK study design, bioanalytical method development, and translational biomarker strategy. This person will support pharmacology and nonclinical toxicology programs, providing broader context across the nonclinical development portfolio. The ideal candidate brings deep scientific expertise and a hands-on approach and thrives in the fast-paced environment of a clinical-stage biotech where both scientific and strategic contributions are expected
- Alltrna is the first clinical-stage biotech company advancing tRNA medicines to address shared disease-causing mutations across many indications. The company’s initial therapeutic programs are designed to restore full-length protein production in diseases caused by premature termination codons (PTCs), collectively referred to as Stop Codon Disease, which affects approximately 10% of people with a rare genetic disease. Alltrna’s lead program, AP003, is a chemically modified, engineered tRNA oligonucleotide encapsulated in a clinically validated, liver-directed lipid nanoparticle. AP003 is being developed for the arginine-to-TGA (Arg-TGA) PTC in patients with liver Stop Codon Disease, including phenylketonuria, organic acidemias, and urea cycle disorders. Founded in 2018 by Flagship Pio
- For more information, visit
- The salary range for this role is $179,000 - $236,000. Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Alltrna currently offers healthcare coverage, annual incentive program, retirement benefits and a broad range of other benefits. Compensation and benefits information is based on Alltrna's good faith estimate as of the date of publication and may be modified in the future.
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