Senior Director, Head of Pharmacokinetics, Bioanalysis and Preclinical Safety

About Alltrna

Alltrna unlocks tRNA biology to treat disease. The company’s platform incorporates AI/ML tools to develop and deliver diverse programmable molecules with broad therapeutic potential. Alltrna has an unprecedented opportunity to advance a single tRNA medicine to readthrough premature stop codons and unify treatment across a wide range of diseases with the same underlying genetic mutations. Alltrna was founded in 2018 by Flagship Pioneering. For more info, visit www.alltrna.com.

The Position: 

As part of the Therapeutic Development Team, you will be leading the team for DMPK Bioanalysis and Preclinical Safety in close collaboration with other functional areas, from computational and molecular biology, in-vitro and in-vivo pharmacology, medicinal chemistry and CMC, to Clinical Development and Regulatory, and supported by external consultants as required. The ideal candidate will therefore need to demonstrate a scientific curiosity around novel RNA therapeutics, have a broad understanding of the drug discovery and early development process and possess well-developed team leadership skills that will facilitate consultation and seamless transfer of information across these constituencies, combined with a strong track record in data integrity and documentation.

Core Responsibilities: 

• Accountable for PK, ADME, bioanalytical and preclinical safety packages and recommendations that contribute to regulatory filings and support the advancement of our novel tRNA modality into clinical trials
• Plan, manage and deliver scientific and operational activities related to PK, ADME, Bioanalysis, Biomarkers, and Preclinical Safety that enable and support tRNA therapeutics along discovery, preclinical and early clinical development
• Develop and maintain clearly defined study planning and execution capabilities that include study protocol preparation and review, project management, data analysis and reporting, study document management, and preparation of study reports
• Build, develop, and manage a highly skilled and motivated team that combines domain expertise, scientific excellence, cross functional integration, and ensure alignment with the company budget to meet company goals

• Establish and maintain effective relationships with contract research organizations (CROs) and external consultants. Design, contract and manage studies at CROs to deliver high quality in vitro, in vivo and clinical data packages for PK, ADME, biomarkers, and preclinical safety

• Operate in close collaboration with the Leadership Team, and functional areas such as medicinal chemistry, pharmacology, translational M&S, informatics, CMC, clinical development and regulatory, and be a positive contributor to company culture in a matrixed team environment
• Provide updates to the Leadership Team to define strategy/tactics and propose mitigation of roadblocks and risks
• Exemplify and expect scientific excellence and a focus on data integrity in all aspects of the role 

 

Qualifications and Skills

• PhD in biology/pharmacology/PK/chemistry-focused sciences and 12+ years of drug discovery or development experience working within or leading a PK, DMPK and/or Bioanalysis group in the biotech or pharmaceutical industry 
• Expert knowledge of oligonucleotide PK, ADME, and biodistribution properties and determinants of delivery
• Expert knowledge of bioanalytical methods, validation and data interpretation for quantitative assessment of nucleic acids, biomarkers and ADA in various tissues and biological matrixes
• Experience with preclinical safety strategies and assessments for nucleic acids
• Experience with NCA data analysis, interpretation, and reporting
• Experience with PK and PKPD analyses, dose prediction and dose selection for animal studies and translation to human clinical studies
• Experience with formulation and tissue delivery strategies for nucleic acids 
• Experience with and knowledge of GLP method development, GLP study design and reporting requirements 
• Demonstrated ability to lead R&D teams and projects in matrixed environments 
• Excellent organizational skills, effective project manager and team leader 
• Established and demonstrated ability of clear and concise written communication

 

What We’ll Offer You

• Comprehensive, competitive healthcare and dental coverage through Blue Cross Blue Shield, vision coverage through VSP, family leave, paid time off, 401k retirement plan, disability and life insurance, and fully covered parking/commuter benefits.
• A dynamic early-stage work environment and highly interdisciplinary, talented, and collaborativ