Principal / Senior Principal Scientist, DMPK

Flagship Pioneering, Inc.; Cambridge (MA); On-site; USD 179,000 - 236,000; Full time

Job summary

Alltrna is the first clinical‑stage biotech company advancing tRNA medicines to address disease‑causing mutations. This DMPK leader role guides strategy across nonclinical and clinical programs, hands‑on in PK/PK‑PD study design, data analysis, and biomarker translation.

Join a fast‑paced clinical‑stage environment reporting to the Chief Scientific Officer. The ideal candidate has deep DMPK expertise, CRO oversight experience, and a hands‑on leadership style that drives dose selection and

Qualifications

• PhD or equivalent in pharmacokinetics, pharmacology, biochemistry, or related field.

Responsibilities

• Lead DMPK strategy and oversee bioanalytical work across nonclinical and clinical programs, including PK and translational PD readouts.
• Oversee development, qualification, and validation of nonclinical and clinical bioanalytical assays (GLP/GCP‑compliant as required), as well as sample analysis, working with internal and CRO analytical scientists.
• Design, execute, and oversee PK and PK‑PD studies of tRNAs to evaluate delivery technologies (LNP and others), biodistribution, and biomarker effects.
• Lead PK and PK‑PD data analysis and interpretation across mouse, rat, NHP, and human studies to support dose selection.
• 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 nonclinical sections) 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.

Skills

DMPK strategy leadership

PK/PK-PD study design

Bioanalytical oversight

CRO/vendor oversight

In vivo PK studies

PK data analysis

Translational biomarker strategy

Scientific writing

Education

PhD or equivalent in pharmacokinetics, pharmacology, biochemistry, or related field

Tools

Phoenix WinNonlin

LC-MS/MS

NGS

Job description

Reporting to the Chief Scientific Officer, this role leads DMPK strategy and oversees bioanalytical work across nonclinical and clinical programs, operating as a hands‑on scientific leader. We are looking for an accomplished DMPK scientist with experience in PK and PK‑PD study design, PK data analysis and interpretation, 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.

Responsibilities

• Lead DMPK strategy and oversee bioanalytical work across nonclinical and clinical programs, including PK, biomarker, and translational PD readouts
• Oversee development, qualification, and validation of nonclinical and clinical bioanalytical assays (GLP/GCP‑compliant as required), as well as sample analysis, working with internal and CRO analytical scientists
• Design, execute, and oversee PK and PK‑PD studies of tRNAs to evaluate delivery technologies (LNP and others), biodistribution, and biomarker effects
• Lead PK and PK‑PD data analysis and interpretation across mouse, rat, NHP, and human studies to support dose selection
• 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 nonclinical sections) 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, or related field
• 8+ years of industry experience in DMPK or a closely related function
• Working knowledge of bioanalytical methods (e.g., LC‑MS/MS, ligand binding assays, NGS) sufficient to oversee their development, qualification, and validation and the associated sample analysis in nonclinical and clinical contexts
• Demonstrated CRO oversight - vendor qualification, study monitoring, data review
• Experience designing and overseeing in vivo nonclinical PK and PK‑PD studies for novel delivery modalities; LNP experience preferred
• Hands‑on experience with PK and PK‑PD data analysis (e.g., noncompartmental analysis) and associated software (e.g., Phoenix WinNonlin), applied to the design and interpretation of nonclinical and clinical studies
• 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 or genetic medicine
• Experience with RNA‑based therapies
• 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 ligand binding assays and multiplex immunoassay platforms (e.g., MSD, Luminex) for cytokine, immunogenicity, and biomarker analysis

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

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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