Sr. Principal Scientist / Director, DMPK & Bioanalytical Sciences

Responsibilities

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

Required Qualifications

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

Preferred Qualifications

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

About Alltrna

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 Pioneering, Alltrna has built an integrated platform to design, optimize, and deliver engineered tRNA therapeutics.

For more information

Visit www.alltrna.com

Pay

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.

Benefits

Alltrna currently offers healthcare coverage, annual incentive program, retirement benefits and a broad range of other benefits.

Contact

To learn more about building your career at Flagship Pioneering, Inc., visit https://jobs.flagshippioneering.com/.

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