Careers

SCOPE

This is a challenging role for a scientist who is a self-starter with excellent communication skills to set-up and lead our in vivo pharmacology efforts. You will report to the Senior Vice President, Research and Development.

Essential Duties and Responsibilities

• Lead internal effort for identifying relevant animal models of disease for neurodegenerative and neurodevelopmental disorders; will require significant interaction with Axial scientists, development team, co-founders and Scientific Advisory Board
• Provide key to therapeutic discovery and development programs by contributing to translational strategy from lab to clinic
• Depending on level, supervise pharmacology team or potentially all of internal biology team
• Identify and qualify specialty CRO’s for in vivo pharmacology studies
• Directly and indirectly manage in vivo studies done at Clinical Research Organizations (CRO’s) and/or collaborators
• Directly and indirectly design and execution of animal studies
• Contribute to interpretation of clinical pharmacology data and preparation of final clinical study reports
• Contribute to the writing of relevant reports that may be included in regulatory fillings
• Participate in Company planning and strategy

Qualifications

• PhD or equivalent with 10+ years of relevant biotech or pharma experience, preferably in neurology/neuropharmacology/neurodegeneration/neuroinflammation or related field
•  Demonstrable experience with drug discovery and neurologic diseases preferred
• Experience in models and studies involving germ-free animals preferred
• Ability to manage multiple projects and identify and resolve issues
• At ease in small biotech organizations, with ability to operate at strategic and detailed levels and the ability to perform under challenge, in fast-moving environments
• Thrives in matrix management structure that relies on team approach
• Establishes good relationships and communicates clearly at all levels within the organization, contributes to building a supportive Corporate culture
• Able to serve as positive mentor for scientists
• Excellent interpersonal and writing skills
• Results oriented with excellent decision-making skills

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Scope of Role

In this role the Research Associate will support biology as a member of a highly matrixed drug discovery team and will be responsible for the execution and troubleshooting of various biological assays and experiments.  This pro-active researcher will collaborate with team members, identify opportunities to improve efficiency, share ideas and expertise and contribute to Axial’s creative, dynamic and collaborative culture.

Essential Duties and Responsibilities

• Provide critical laboratory support while working as part of an energetic, collaborative team
• Assist with the optimization and validation of cell-based or biochemical assays to support ongoing discovery projects
• Use cellular or biochemical assays to characterize small molecules and biologics that modulate pathways relevant to pathological processes driving neurological diseases or cancer
• Analyze and report data to multidisciplinary teams of scientists internally
• Maintain excellent and detailed records in an electronic notebook
• Prepare laboratory reagents and order supplies and equipment

Qualifications

• Careful, thoughtful and collegial bench scientist with experience and proficiency with a variety of molecular and cell biology techniques such as cell culture, Westerns or ELISA, PCR, transfections or transformations, and protein purification
• Strong scientific curiosity, ability to rapidly learn new laboratory and data analysis methods
• Self-starter with strong problem-solving abilities and resourcefulness, and an outstanding team player with ability to work in groups as well as independently
• Highly detail-oriented and organized with strong analytical skills
• Ability to multitask, prioritize, and function in a fast-paced, entrepreneurial environment
• Bachelor’s degree in biology, biochemistry or a related field preferred, with at least 1-3 years of relevant lab experience
• Experience supporting drug discovery programs preferred

TO APPLY: Please visit https://axialtx.com/careers/

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Scope of Role

In this role, the Research Associate will apply critical thinking, careful technical execution and aptitude for developing new dosage forms. The individual will develop oral modified release solid dosage forms for different therapeutics. 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

• Utilize formulation equipment, such as fluidized bed coater, tableting machine, etc.
• Develop and execute design of experiments (DOE) to explore modified release formulations for tablet/capsule/bead dosage forms\
• Evaluate the effect of formulation and processing factors on the physical and release characteristics from the dosage forms
• 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

• Prior work experience with tableting, encapsulation and air suspension granulation/coating
• 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
• Graduate student or experienced undergraduate student in pharmaceutical sciences or relevant polymer sciences field

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About Axial Therapeutics:

At Axial, our focus is to revolutionize the way we treat neurological conditions and cancer by exploiting the ways the gut microbiome interacts with us.  We are a tight knit group of scientific, clinical development and operations professionals who are unrelenting in our pursuit to discover and develop new treatments for those patients in desperate need of them.

We successfully completed our first clinical study in Autism and moving forward with the next phase of development which created the opportunity for an enthusiastic and energetic CTM to join and complement our Clinical Operations team in preparing and driving the next phase in these therapeutic areas.  To be successful in this role, you need to be someone who shares our passions, commitment to patients and can thrive in the fast-paced environment of a small growing biotech company.

Your Role:

• Efficiently manage and oversee the setup, development, and management of global clinical trial programs and simultaneous clinical studies from concept through clinical study report completion and ensures that all aspects of the study are conducted in accordance with all applicable regulations and internal SOPs to support business strategic initiatives.

• Review and provide input to clinical protocols for feasibility of clinical trial conduct; identify potential risks and obstacles and identifies opportunities for accelerating the delivery of those studies.
• Lead the development of, and ensures adherence to clinical study plans (quality, vendor management and oversight, data management, site monitoring, TMF quality control, and study communication plans).
• Act as the main study focal point, establish and maintain key strategic relationships with service providers, networks of clinicians, and internal partners for effective roll-out of the trials.
• Develop, track, and ensure that clinical trial programs meet timelines and study budget while ensuring patient safety and data quality.
• Support and contribute to the ongoing improvement and review of clinical and regulatory documentation and processes for the group.

• Plan and manage multi-center, multi-national clinical trials including management of relationships with clinical sites and oversight of their activities; work with Clinical Operations Management and QA to resolve issues or problems with/at the sites.

• Develop study-specific strategies and executes associated plans that ensure robust patient enrollment.
• Proactively alerts Senior Management and QA to risks/challenges and provides appropriate solutions to mitigate them in collaboration with QA.
• Support the development of protocols, informed consent forms, investigational plans, and study materials (e.g., training materials, case report forms, Pharmacy Manual, Trial Master Files, Clinical supplies).
• Support regulatory filings and submissions, as necessary.
• Actively participates in the development of department initiatives by providing input on departmental initiatives and goals to enhance the capabilities of Axial’s Clinical Operations team.
• Participate in cross-functional teams to achieve clinical program objectives within the broader context of Axial’s business goals and future expansion.

Education & Experience Requirements

• Minimum of bachelor’s degree or equivalent in scientific, nursing, or medical discipline.
• Minimum of 7+ years of Clinical Trial Management experience
• Patient-focused and quality mindset
• Demonstrates thorough knowledge and understanding of key regulatory requirements, relevant ICH Guidelines including cGCP.
• Experience in communicating protocol requirements clearly and concisely to all key participants in trials.
• Proven ability to proactively identify, mitigate and resolve project risks.
• Proven ability to work collaboratively with multifunctional teams and relentless in pursuing successful outcomes.
• Experience in using EDC and CTMS systems
• Experience working in a neurodegenerative disease or neurodevelopmental disorder therapeutic areas strongly preferred.

Key Skills and Competencies

• Ability to manage key components of clinical trials independently with limited supervision.
• Strong verbal, written and presentation skills.
• Demonstrable advanced knowledge of relevant software packages (e.g., Microsoft Project, Word, Excel, PowerPoint).
• Ability to efficiently organize and prioritize work within a multifaceted framework and set deadlines.
• Flexibility in working hours and readiness to travel.
• Thrives in a fast paced, multi-tasking, startup environment.