Senior DMPK & Bioanalytical Science Leader (PK-PD)

Flagship Pioneering, Inc.

Cambridge (MA)

On-site

USD 179,000 - 236,000

Full time

12 days ago

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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

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

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