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Entrada Therapeutics

Related companies:

🏢 Apellis
🏢 Centessa Pharmaceuticals, LLC
🏢 Precision for Medicine

Jobs at this company:

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🔥 Principal Scientist, DMPK
Posted 2024-11-07

📍 New England

🧭 Full-Time

🔍 Biopharmaceutical

  • PhD in pharmacology or similar field with 8+ years of DMPK experience in an industry setting or a MS with 12+ years of relevant experience.
  • Expertise with ADME studies and assays, with a proven track record of strategizing and troubleshooting based upon raw data.
  • Vendor management experience, specifically managing CROs.
  • Additional experience with other aspects of ADME, bioanalytical techniques, PK/PD, toxicokinetics, pre-clinical PK/PD modeling, and translational biology are strongly preferred.
  • Experience with oligonucleotide-based modalities.
  • Experience authoring and reviewing DMPK-related reports and regulatory documents for health authority submissions is highly desirable.
  • Collaborative and strong communication skills.
  • Ability to multi-task effectively and work within aggressive timelines.

  • Lead all PK- and ADME-related efforts for designated program(s).
  • Communicate and present relevant information across all areas of the organization, regardless of level.
  • Select and manage PK/TK, PK/PD, and ADME CROs.
  • Author and review PK/TK, PK/PD, and ADME reports.
  • Author and review relevant PK/TK, PK/PD, and ADME sections of regulatory submission documents.
  • Review associated reports, including clinical, toxicology, pharmacology, and bioanalysis.
  • Collaborate with clinical teams, including pharmacology, biomarkers, development, and operations.
  • Collaborate with non-clinical development teams, including toxicology and bioanalysis.
  • Collaborate with discovery teams to guide future programs and better understand mechanisms of action.

LeadershipCross-functional Team LeadershipCommunication SkillsAnalytical SkillsCollaboration

Posted 2024-11-07
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🔥 Director, Biostatistics
Posted 2024-11-07

📍 United States

🧭 Full-Time

🔍 Biopharmaceutical

  • PhD with 10+ years or MS with 12+ years of relevant statistical analysis roles in the biotech/pharmaceutical industry.
  • Experience with a broad array of statistical approaches and proposing novel approaches.
  • Demonstrated track record in various disease indications and appropriate statistical requirements.
  • Experience in supporting responses to health authorities (FDA, EMA).
  • Strong vendor management and oversight experience.
  • Proficiency in statistical analysis software (SAS and R) and sample size calculation software.
  • Excellent verbal and written communication skills.

  • Responsible for leading statistical strategy for assigned drug programs, including input to clinical development plans and protocols design.
  • Accountable for oversight of the production of biostatistics deliverables.
  • Serve as a key leader in the clinical product team, providing statistical strategy and inputs in various study documents.
  • Author/review the statistical analysis plan for clinical trials.
  • Define/review the randomization procedures and oversight.
  • Review study documentation to ensure statistical requirements are met.
  • Oversee outsourced statistical CRO activities and deliverables.
  • Support the development of department strategies.

LeadershipData AnalysisPeople ManagementCross-functional Team LeadershipData analysisCommunication SkillsAnalytical SkillsCollaboration

Posted 2024-11-07
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