Sr. Principal Scientist Director, DMPK & Bioanalytical Sciences

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

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 companys 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 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.

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The salary range for this role is $179000 - $236000. Compensation for the role will depend on a number of factors including a candidates 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 Alltrnas good faith estimate as of the date of publication and may be modified in the future.

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