Sr. Principal Scientist / Director, DMPK & Bioanalytical Sciences at Flagship Pioneering, Inc.

About the role

In this position, you will be responsible for directing the DMPK and bioanalytical strategies for both nonclinical and clinical programs. As a hands-on scientific leader, you will contribute significantly to pharmacology and toxicology initiatives, ensuring alignment across the nonclinical development portfolio. We seek a seasoned expert in DMPK and bioanalytical sciences who can thrive in a dynamic clinical-stage biotech environment.

Key facts

Location: Cambridge, MA, USA

Engagement: Full-time

Team: Research Leadership Team

What you’ll do

- Oversee the DMPK and bioanalytical strategy for nonclinical and clinical initiatives, focusing on pharmacokinetics, biomarkers, and translational pharmacodynamics.
- Lead the development, qualification, and validation of bioanalytical assays, ensuring compliance with GLP and GCP standards when necessary.
- Design and manage pharmacokinetic and pharmacokinetic-pharmacodynamic studies for tRNA therapies to assess delivery technologies and biomarker impacts.
- Collaborate with CROs and external laboratories to manage bioanalytical and pharmacokinetic programs effectively.
- Work alongside internal teams and CROs to support nonclinical toxicology programs.
- Analyze and present DMPK and biomarker data to both internal leadership and external stakeholders.
- Prepare nonclinical sections of regulatory submissions, including IND applications, and assist with agency interactions.
- Represent DMPK and bioanalytical sciences in cross-functional program discussions as a member of the Research Leadership Team.




- Supervise and mentor direct reports while collaborating with the pharmacology team.

Requirements

- PhD or equivalent in pharmacokinetics, pharmacology, biochemistry, analytical chemistry, or a related discipline.
- A minimum of 8 years of relevant industry experience in DMPK or bioanalytical sciences.
- Proficiency in various bioanalytical techniques and their development, qualification, and validation in both nonclinical and clinical settings, including mass spectrometry, ELISA, and NGS.
- Experience with ligand binding assays and multiplex immunoassay platforms, such as MSD and Luminex, for analyzing cytokines, immunogenicity, and biomarkers.
- Proven ability to oversee CROs, including vendor qualification and study monitoring.
- Experience in designing and managing PK and PK-PD studies for innovative delivery systems, with a preference for LNP experience.
- Background in developing translational or clinical biomarkers, including assay strategy and qualification.
- Strong writing skills for regulatory documents and internal reports.
- Experience in supervising and developing scientific staff.

Nice to have

- Experience in rare diseases, genetic medicine, or nucleic acid/RNA therapeutics.
- Knowledge of LNP platform biology and delivery systems.




- Familiarity with GLP toxicology study design and ICH nonclinical guidelines.
- Background in a leadership role within a clinical-stage biotech environment.
- Experience with LC-MS/MS or similar mass spectrometry technologies.

About Alltrna

Alltrna is pioneering tRNA medicines at the clinical stage, targeting shared disease-causing mutations across various conditions. The company's initial therapeutic programs aim to restore full-length protein production in diseases caused by premature termination codons (PTCs), known collectively as Stop Codon Disease, which affects around 10% of individuals with rare genetic disorders. Alltrna's lead program, AP003, is a chemically modified tRNA oligonucleotide encapsulated in a clinically validated, liver-targeted lipid nanoparticle. It 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. Established in 2018 by Flagship Pioneering, Alltrna has developed an integrated platform for designing, optimizing, and delivering engineered tRNA therapeutics.

The salary range for this position is $179,000 - $236,000. Compensation will be determined based on various factors, including the candidate's qualifications, skills, and experience.

Alltrna provides healthcare coverage, an annual incentive program, retirement benefits, and a comprehensive benefits package. This compensation and advantages information reflects Alltrna's good faith estimate as of the publication date and may be subject to change in the future.

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📌 Sr. Principal Scientist / Director, DMPK & Bioanalytical Sciences (Cambridge)
🏢 Flagship Pioneering
📍 Cambridge