Axial Biotherapeutics is a biopharmaceutical company harnessing the link between the human gut microbiome and the Central Nervous System to develop a new class of therapeutics that improves the quality of life for people with CNS diseases and disorders.  In this exciting lab-based position, this scientist will apply their expertise in cell biology, biochemistry and assay development while collaborating closely with a passionate team in a dynamic environment to deliver important new medicines that help patients and their families.

To apply, please send your resume and cover letter to careers@axialbiotherapeutics.com

Scope of Role

Reporting to the Chief Medical Officer, the Senior Director of Clinical Operations will be responsible for overseeing the strategy for implementation as well as execution of all Axial sponsored clinical trials within established timelines, budget and quality standards.  In addition, the successful candidate will ensure the appropriate company infrastructure is in place to support the planned clinical trial programs for Axial’s therapies.  This individual will be responsible for leading all operational aspects of Axial’s clinical trial programs.  Finally, the person in this position is accountable for adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Essential Duties and Responsibilities
  • Ensures that external vendors are selected and managed to deliver within established timelines and budget. This also includes site qualification and initiation.
  • Provides strategic and technical guidance to ensure that clinical trials are properly defined, planned and executed. Leads and directs the clinical operations team responsible for management and execution of all clinical trials. This includes but is not limited to, ensuring cost, quality and timeliness of multiple programs is met.
  • Working in a matrix organization, ensures that study objectives are in line with the clinical development strategy and the overall corporate goals.
  • Leads and directs the building of department infrastructure, including developing, training, and retaining the clinical operations team; ensures prioritization of activities and resourcing is in line with clinical development programs.
  • Drives the creation of clinical operations Standard Operating Procedures (SOPs), systems, and processes across the trials; ensures compliance with regulatory and other applicable standards and guidelines.
  • Builds collaborative relationships with key internal stakeholders including Clinical, Product Development, Program Management, Regulatory Affairs, IT, Legal, Finance departments, and project teams as needed to support clinical programs.
  • Collaborate with KOLs for feedback on study protocols and development plans.
  • Fosters a highly collaborative culture and serves as a leadership role model within the company and with external stakeholders.
  • Contributes to business development activities as needed. This may include providing critical due diligence and analysis of programs.
Qualifications
  • Minimum education: M.S. /B.S in life sciences, scientific or other relevant discipline.
  • 10+ years of strong hands-on experience leading global clinical trials execution, preferably in CNS conditions.
  • Experience with Phase 1-3 trials
  • Proven ability to build strong relationships with external partners, CROs, and vendors including extensive experience managing contracts and clinical finance activities.
  • In-depth, working knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
  • Ability to work independently and collaboratively in a fast-paced, matrixed, team environment consisting of internal and external team members.
  • Analytical thinker with excellent problem solving skills and the ability to adapt to changing priorities and deadlines.
  • Excellent verbal and written communication skills.

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Scope of Role

This independent, proactive and creative bench scientist will apply their extensive expertise in cell biology, biochemistry and assay development to help drive Axial’s drug discovery efforts.  Key responsibilities include developing and implementing in vitro assays to support the selection of novel drug candidates and investigation of pathological mechanisms affecting the gut-brain axis.   As a member of our discovery team, this scientist will share and expand their expertise, contribute intellectually across disciplines, and learn new skills, supporting Axial’s creative, dynamic and collaborative culture.

Essential Duties and Responsibilities
  • Apply extensive expertise, creative thinking and trouble-shooting to develop and implement new cell-based and biochemical assays to screen potential therapeutics, elucidate their mechanism of action and enrich our understanding of disease processes
  • Design and execute studies and present data with scientific rigor and technical excellence, working independently and collaboratively as part of an outstanding team
  • Provide technical and scientific thought leadership in cell biology and biochemistry while personally executing multiple efforts with considerable efficiency and flexibility
  • Share ideas, creativity and critical thinking across functions, inside and outside the lab, and embrace input from teammates
  • Expand knowledge-base and cross-train with colleagues in other areas, including microbiology
  • Maintain detailed records in an electronic notebook, promote safety and compliance in a BL2 laboratory environment, and contribute actively to the smooth operation of the lab
Qualifications
Essential:
  • Outstanding scientific background in cell biology and biochemistry, preferably in neuroscience, gastroenterology, inflammation or immunology
  • Expert in development, execution and transfer of cellular and biochemical assays to support drug discovery, including hit to lead and lead optimization
  • Strong background in mammalian cell culture, eg, various methods for transient or inducible expression of targets, engineering of stable cell lines, and/or isolation of primary cells
  • Deep and broad technical skill set enables measurement of cellular responses at the level of gene, protein, signal transduction and cellular phenotype
  • Excellent track record of teamwork, strong communication and focused execution
  • BS, MS with 8+ years or PhD with 3+ years laboratory experience, or equivalent
Desirable:
  • Neurobiology, microbiology and/or microbiome experience

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Scope of Role

In this role, the Research Associate will apply critical thinking, careful technical execution and aptitude for learning new techniques while running established cell-based and biochemical assays, supporting the development of new assays, and analyzing data to support Axial’s drug discovery pipeline. This pro-active researcher will collaborate with fellow team members, ensure the smooth function of the lab, look for opportunities to improve efficiency, and share ideas and expertise. They will contribute to Axial’s creative, dynamic and collaborative culture and advance new therapies targeting the gut-brain axis to help patients with neurological diseases and disorders.

Essential Duties and Responsibilities
  • Execute cellular and biochemical assays to characterize small molecules, biologics and microbes that modulate pathways relevant to pathological processes driving CNS diseases and disorders such as Autism Spectrum Disorder and Parkinson’s Disease
  • Optimize, trouble-shoot and validate cell based and/or biochemical assays in concert with colleagues to support drug discovery projects
  • Analyze and report data to multidisciplinary teams
  • Share ideas, creativity and critical thinking across functions, inside and outside the lab, and embrace input from teammates
  • Maintain detailed records in an electronic notebook, promote safety and compliance in a BL2 laboratory environment, and contribute actively to the smooth operation of the lab
Qualifications
  • Careful, thoughtful and collegial researcher with significant experience in assay development, assay optimization and compound screening to support drug discovery programs
  • Proficiency with a variety of cell biology, microbiology, molecular biology and/or biochemical techniques such as cell culture, qRT-PCR, Westerns or ELISA, protein purification, cloning, transfections, etc.
  • Self-starter with strong problem-solving abilities, resourcefulness, scientific curiosity and desire to learn
  • Outstanding team player with excellent track record working in groups as well as independently, with outstanding and proactive communication
  • Highly detail-oriented and organized, with strong analytical skills and experience reporting data
  • Ability to multitask, prioritize, and function in a fast-paced, entrepreneurial environment
  • Bachelor’s or Master’s degree in biology, biochemistry or a related field, with at least 3-5 years of relevant lab experience, preferably in an industrial drug discovery setting

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Note to Employment Agencies

Axial Biotherapeutics values our relationships with our Recruitment Partners and will only accept resumes from those partners whom have been contracted by a member of our Human Resources team to collaborate with us.  Axial Biotherapeutics is not responsible for any fees related to resumes that are unsolicited or are received by any employee of Axial Biotherapeutics who is not a member of the Human Resources team.