Careers

Join our Team

At Sio Gene Therapies, we are working together to develop gene therapies that will transform the lives of patients. Our team is committed to advancing our adult neurodegenerative and rare fatal pediatric programs through clinical development so that patients can access the therapies they need.

We are looking for people who are excited about cutting-edge science and want to build a world-class gene therapy company.

At Sio, we are location-agnostic and have capabilities to be fully virtual. We hire entrepreneurial, talented and passionate individuals regardless of location. Join our team if you want to push the boundaries of gene therapy to make a difference in the lives of patients.

Sio is Worldwide.

Full time position – Remote

Company Summary

Sio Gene Therapy is a biopharmaceutical company committed to developing treatments for CNS diseases. The company has rapidly built a diverse portfolio of gene therapy candidates with the potential to address debilitating CNS genetic diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are no approved therapies.  Additionally, the company is focused on more common debilitating CNS diseases, such as Parkinson’s Disease.

Developing new genetic treatments for these diseases is challenging work. It takes courage, talent, and dedication to look past the easy answers and uncover new solutions that can make a meaningful impact. At Sio we push each other to perform at our very best to make a difference in our patients’ lives.

Overall Summary

Sio Gene Therapies is seeking a highly motivated Director, Analytics, for Sio Gene Therapies’ AAV gene therapy programs. Reporting to the Vice President of Technical Operations, the Director, Analytical Development and Quality Control, will be responsible for the strategy and execution of development, qualification and validation activities related to AAV-based gene therapy programs, including oversight of activities at contract organizations, as well as providing support for relevant submissions to regulatory agencies.

Primary Responsibilities

These may include but are not limited to:

  • Development of phase-appropriate testing strategies for viral gene therapy vectors.
  • Identification and selection of contract testing organizations for performing development as well as product release testing.
  • Responsibility for the development and implementation of assays at contract laboratories.
  • Oversight of technical transfer between laboratories, qualification/validation of assays and QC activities for material release.
  • Coordination with internal and external parties, including Program Management, Process Development, Manufacturing, Supply chain, Quality Assurance, Regulatory Affairs and Clinical Operations.
  • Timely development of assays as well as testing of samples for material release.
  • Identification and communication of risks in assay performance and their mitigation.
  • Responsibility to develop, author, review, and/or approve Standard Operating Procedures, specifications, regulatory filing, or other controlled documents as needed.
  • Representation of the company as analytical expert.

Desired Skills and Experience

  • M.S or equivalent in Chemistry, Biological Sciences, Engineering or related discipline, with 10+ years of experience; Ph.D. with 6+ years of experience preferred.
  • Expertise in gene therapy projects required.
  • Familiar with assay development, qualification and validation activities essential.
  • Expertise in early development, preferably in late stage/commercial pharmaceutical projects.
  • Experience managing contract organizations.
  • Experience managing team members essential.
  • Familiar in efficiently interacting with Quality Assurance and Regulatory Affairs.
  • Occasional travel to contract organizations required.
  • Familiarity with regulatory requirement for testing of viral gene therapy products.
  • Excellent written and verbal communication skills, good interpersonal and management skills to collaborate with and direct the work of others on assigned projects (including both internal teams and external collaborators).
  • Results oriented, has a bias for action. Strong initiative, accountability and willingness to take ownership and drive projects to completion.
  • Accustomed “roll up their sleeves” and execute the tasks needed in a small company environment.
  • Ability to set priorities, work independently and deliver results in a timely manner. Display a sense of urgency.
  • Remote work location possible

This is an exciting time to join the field of gene therapy in general, and to become a part of Sio Gene Therapies’ fast-growing dedicated team. Sio Gene Therapies is a publicly traded company. We offer an exciting, meaningful and collaborative fast-paced environment with a foundation of sound and rigorous science. Competitive compensation and benefits package can be expected.

All interested applicants should send a cover letter and resume to:  HR@siogtx.com

Full time position – Remote

Company Summary

Sio Gene Therapy is a biopharmaceutical company committed to developing treatments for CNS diseases. The company has rapidly built a diverse portfolio of gene therapy candidates with the potential to address debilitating CNS genetic diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are no approved therapies.  Additionally, the company is focused on more common debilitating CNS diseases, such as Parkinson’s Disease.

Developing new genetic treatments for these diseases is challenging work. It takes courage, talent, and dedication to look past the easy answers and uncover new solutions that can make a meaningful impact. At Sio we push each other to perform at our very best to make a difference in our patients’ lives.

Primary Responsibilities

  • Provides quality assurance operations/compliance subject matter expertise, continuous quality oversight, support, and timely resolution of quality issues as it pertains to external global contract manufacturing and studies in support of CMC project teams, early development (GLP), and regulatory submissions for pipeline products.
  • Escalates significant quality/compliance issues to the Quality Head and other area Management.
  • Develops, implements, and maintains internal QMS procedures.
  • Monitors internal site and external vendor conformance with applicable QMS policies, SOPs, and regulations.
  • Manages the internal audit, departmental self-inspection, and mock inspection program to ensure continuous site compliance
  • Executes and maintains the external vendor GMP/GLP schedule, audit execution, reports, and follow ups.
  • Develops and executes on plans to ensure internal site/external vendor preparedness for Regulatory/Health Authority preapproval and routine inspections.
  • Supports regulatory inspection activities and generation of responses to related observations.
  • Develops and maintains systems for as well as executes quality review and approval of:
    • Production and quality-related investigations and deviations
    • OOS and laboratory investigations
    • CAPA management and change management
    • Customer complaints/inquiries
    • Audits and quality agreements
    • Risk assessments
    • CMC documentation/records:
      • Master and executed manufacturing records
      • Process validation protocols & reports
      • Analytical method qualification & validation
      • Product storage and distribution
    • GLP documentation/records:
      • Nonclinical animal/toxicology study protocols & reports
      • Bioassays validation protocols and reports
    • Document control and records retention
    • Voluntary/Regulatory Authority Field Actions and Recalls
  • Coordinates and/or performs employee training on behalf of the Quality Assurance department and maintains employee training files.
  • The colleague will be held accountable for development, contributing to, and/or and reporting of periodic metrics to management for assigned areas of responsibility to drive process improvement.

Support of the implementation and maintenance of an electronic QMS and other applicable software applications as needed

Requirements

  • Bachelor’s degree from an accredited university in a scientific/technical discipline or related discipline
  • 5-10 years of extensive experience in GMP/GLP Quality, preferably in a start-up, clinical stage and/or commercial Viral Vector Gene Therapy or similar Biotechnology company (an equivalent combination of education and experience may be considered)
    • Demonstrated proficiency in R&D, GMP, and GLP Quality Assurance Operations, Quality Management Systems (QMS) development/implementation, Quality Compliance, Performance Monitoring, Process Improvement, Training, and/or Document Management.
    • Demonstrated experience in GMP/GLP contract organization and vendor quality management in support of production, nonclinical studies, and bioassays
    • GMP/GLP Audit Experience
  • Project management, relationship building, collaboration, and negotiation skills with and various internal and external cross-functional teams.
  • Excellent verbal and written communication skills and ability to relay vision/strong sense of department organization, processes, and change to management and personnel
  • Proficiency in use of current hardware and software applications commonly used in a biotechnology or pharmaceutical company quality environment such as MS Office, Box, Veeva Vault, DocuSign.
  • Expertise in FDA/EMA Regulatory Authority requirements and industry standards related to Biotechnology, Pharmaceutical, and Medical Device product such as but not limited to, current GMP, GLP, ICH, Good Documentation Practices, electronic records, signatures, and computerized systems
  • The following are highly desirable:
    • Practical understanding of Gene Therapy manufacturing (LV and AAV), plasmid manufacturing, process validation, GMP/GLP bioanalytical methods (qualification/validation), regulatory submission requirements, medical device (for combination products), quality computer systems/software validation/implementation, other areas relevant to Phase 1 to 4 Clinical Trials/Materials and Commercial Drug Products
    • Familiarity FDA/EMA regulations and GCP/ICH guidelines regarding clinical trial management as well as with CAP/CLIA Guidelines
    • Good Distribution Practices

Working Conditions

  • Availability during Sio’s core business hours
  • Ability to travel up to 20% annually for conduct of quality audits, site visits, other business, and professional development.

This is an exciting time to join the field of gene therapy in general, and to become a part of Sio Gene Therapies’ fast-growing dedicated team. Sio Gene Therapies is a publicly traded company. We offer an exciting, meaningful and collaborative fast-paced environment with a foundation of sound and rigorous science. Competitive compensation and benefits package can be expected.

All interested applicants should send a cover letter and resume to:  HR@siogtx.com

Full time position – Remote

Company Summary

Sio Gene Therapy is a biopharmaceutical company committed to developing treatments for CNS diseases. The company has rapidly built a diverse portfolio of gene therapy candidates with the potential to address debilitating CNS genetic diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are no approved therapies.  Additionally, the company is focused on more common debilitating CNS diseases, such as Parkinson’s Disease.

Developing new genetic treatments for these diseases is challenging work. It takes courage, talent, and dedication to look past the easy answers and uncover new solutions that can make a meaningful impact. At Sio we push each other to perform at our very best to make a difference in our patients’ lives.

Primary Responsibilities

  • Provides quality assurance and compliance subject matter expertise, continuous quality oversight, support, and timely resolution of quality issues as it pertains to clinical studies and nonclinical studies in support of project teams, early development, and regulatory submissions for pipeline products.
  • Escalates significant quality/compliance issues to the Quality Head and other area Management.
  • Develops, implements, and maintains internal QMS procedures and their supporting documents.
  • Monitors conformance with applicable QMS policies, SOPs, regulations, guidelines, and industry best practices.
    • Manages and executes the GCP/GLP internal audit, departmental self-inspection, and mock inspection program to ensure continuous site compliance.
    • Executes the clinical site and external vendor GCP/GLP schedule, audit execution, reports, and follow ups through closure.
  • Develops and executes on plans to ensure internal site, external vendor, and clinical site preparedness for Regulatory/Health Authority inspections.
  • Supports regulatory inspections and preparation of responses.
  • Provides quality oversite of, or executes, Clinical (GCP) and Nonclinical Quality Assurance (GLP and CAP/CLIA), Systems, and Compliance activities pertaining to (as applicable):
    • Clinical trial documentation/records such as protocols, pharmacy manual etc.
    • GLP and CAP CLIA bioassay method validation protocols/reports
    • GLP animal studies
    • Deviations and investigations
    • CAPA management and change management (amendments)
    • Risk assessments
    • Voluntary/agency field actions and recalls
    • Document control and records retention
    • Drug safety update reports
    • Data integrity
    • Customer complaints/inquiries
    • CRO and external vendor quality agreements
  • Coordinate and/or performs employee training on behalf of the Quality Assurance department and maintains employee training files.
  • The colleague will be held accountable for development, contributing to, and/or reporting of periodic metrics to management for assigned areas of responsibility to drive process improvement.
  • Support of the implementation and maintenance of an electronic QMS and software applications as needed.

Requirements

  • Bachelor’s degree from an accredited university in a scientific/technical discipline or related discipline
  • 5-10 years of extensive experience in GCP/GLP quality, preferably in a start-up, clinical stage and/or commercial Gene Therapy or similar Biotechnology company (an equivalent combination of education and experience may be considered)
  • Demonstrated proficiency in GCP and GLP Quality Assurance Operations, Quality Management Systems (QMS) development/implementation, Quality Compliance, Performance Monitoring, Process Improvement, Training, and/or Document Management.
  • Demonstrated experience in GCP/GLP contract organization and vendor quality management
  • GCP and GLP Audit experience
  • Project management, relationship building, collaboration, and negotiation skills
  • Excellent verbal and written communication skills and ability to relay vision/strong sense of department organization, processes, and changes to management and personnel
  • Proficiency in use of current software applications commonly used in a biotechnology or pharmaceutical company quality environment such as MS Office, Box, Veeva Vault, DocuSign
  • Expertise in FDA/EMA Regulatory Authority requirements and industry standards related to Current GCP, GLP, Good Documentation Practices, Good Pharmacovigilance Practices, electronic record, signature, and computerized systems
  • Knowledge of CAP/CLIA Guidelines (GCLP)
  • The following are highly desirable:
    • Familiarity with current FDA/EMA GMP
    • Good Distribution Practices

Working Conditions

  • Availability during Sio’s core business hours
  • Ability to travel up to 20% annually for conduct of quality audits, site visits, other business, and professional development.

This is an exciting time to join the field of gene therapy in general, and to become a part of Sio Gene Therapies’ fast-growing dedicated team. Sio Gene Therapies is a publicly traded company. We offer an exciting, meaningful and collaborative fast-paced environment with a foundation of sound and rigorous science. Competitive compensation and benefits package can be expected.

All interested applicants should send a cover letter and resume to:  HR@siogtx.com

Full time position – Remote

Company Summary

Sio Gene Therapy is a biopharmaceutical company committed to developing treatments for CNS diseases. The company has rapidly built a diverse portfolio of gene therapy candidates with the potential to address debilitating CNS genetic diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are no approved therapies.  Additionally, the company is focused on more common debilitating CNS diseases, such as Parkinson’s Disease.

Developing new genetic treatments for these diseases is challenging work. It takes courage, talent, and dedication to look past the easy answers and uncover new solutions that can make a meaningful impact. At Sio we push each other to perform at our very best to make a difference in our patients’ lives.

Overall Summary 

Study clinician supporting gene therapy program(s). Member of the clinical study team(s) supporting execution of clinical program under guidance of SVP – Clinical Development, and accountable for successful and timely delivery of the clinical program. Responsible for supporting design and implementation of clinical protocols, medical monitoring, regulatory reporting, scientific oversight of data collection, and final study report. Contribute to preparation for regulatory meetings to and regulatory filings as applicable. Identification, approval and engagement of investigators.

Primary Responsibilities 

  • Include key interactions or dependencies with other jobs, functional areas and/or external service providers
  • If this role includes people management, describe this in one of the accountabilities below
  • If this role includes financial responsibility (e.g. budget management, forecasting…etc.)

Requirements

  • Protocol development
  • Preparation of documents for US and EU regulators
  • Interactions with development alliance partners
  • Engagement of Investigators and key opinion leaders
  • Support scientific execution of global clinical studies to the highest standards
  • Accountable for supporting the delivery of clinical study plan

Behavioral Requirements 

To achieve our Company’s vision and mission, we move with urgency to develop and deliver innovative gene therapies that could transform the treatment of neurological and neuromuscular diseases. Since every day matters in the lives of our patients, we are committed to hiring people with a sense of urgency and orientation to “do what is right” to develop and deliver innovative gene therapies. We harness breakthrough science to challenge the status quo on behalf of patients and their families. We know that patients cannot wait, and neither will we.

Given our commitment patients and ethics, we seek to hire likeminded individuals who are committed to ethically achieved performance. Behavioral requirements for this position include:

  • Being an integrity role model by visibly and consistently speaking and acting the values of our Global Code of Business Conduct and Ethics
  • Timely completing, and ensuring you understand the content of, all required legal and compliance training courses

Acting with respect and in a professional manner in all business relationships (with colleagues within Sio and with external stakeholders).

Additional Requirements 

Education:

  • MD or MD/PhD with Board certification in neurology preferred.

Experience (e.g. Jobs, supervisory, industry, international, etc…):

  • A minimum of 2 years’ in either biotechnology/pharmaceutical experience or relevant academic research, ideally with gene therapy/precision genetic medicine in the therapeutic area of CNS and rare-disease
  • Knowledge of Parkinson’s disease highly desirable
  • Experience within small biotech organizations a plus

Specialized knowledge, Licenses, etc.:

      1) Gene therapy/editing, precision genetic medicine development

      2) Working knowledge of industry Clinical Development process across Phases I – III

      3) Experience in neurodegenerative disorders including rare disease

Other skills/attributes:

  • Demonstrated alignment with Sio values and culture
  • Excellent written and communication skills
  • Hands-on, can do attitude
  • Critical thinker
  • Personal credibility and poise

Working Conditions (ability to travel, lifting… etc.)

    • Travel ± 10% time: domestic and international

This is an exciting time to join the field of gene therapy in general, and to become a part of Sio Gene Therapies’ fast-growing dedicated team. Sio Gene Therapies is a publicly traded company. We offer an exciting, meaningful and collaborative fast-paced environment with a foundation of sound and rigorous science. Competitive compensation and benefits package can be expected.

All interested applicants should send a cover letter and resume to:  HR@siogtx.com

Full time position – Durham, NC

Company Summary

Sio Gene Therapy is a biopharmaceutical company committed to developing treatments for CNS diseases. The company has rapidly built a diverse portfolio of gene therapy candidates with the potential to address debilitating CNS genetic diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are no approved therapies.  Additionally, the company is focused on more common debilitating CNS diseases, such as Parkinson’s Disease.

Developing new genetic treatments for these diseases is challenging work. It takes courage, talent, and dedication to look past the easy answers and uncover new solutions that can make a meaningful impact. At Sio we push each other to perform at our very best to make a difference in our patients’ lives.

Overall Summary 

The VP/SVP of Nonclinical Development will be a member of the Research and Development leadership team and is a key, high profile position within Sio. The incumbent will report to the Chief R&D Officer, and play a critical strategic role in the nonclinical, bioanalytical, and translational research strategy for the gene therapy products under development.

This role will liaise extensively with collaborators and partners to build and execute a world leading gene therapy pipeline. The ideal candidate will have experience working extensively with CROs and with partners to advance therapeutics targeting Central Nervous Disorders. The incumbent will be a visible and vocal spokesperson providing scientific and strategic input in shaping the R&D and Business Development strategy.

Primary Responsibilities 

  • The candidate will design, lead, and execute individualized nonclinical development plans for each of our gene therapy programs including all nonclinical studies to support the safety and scientific rationale of each gene therapy in the target clinical population, and the Bioanalytical methods supporting Nonclinical/Clinical activities. They will lead, manage, and support a diverse group of scientists working across all gene therapy programs to ensure well designed and executed nonclinical and bioanalytical efforts for each pipeline program through all stages of development.
  • Oversee final design, protocol development, execution, monitoring, and reporting of all pharmacology, biodistribution, safety/toxicology and dose range-finding studies with our gene therapies.
  • Lead partnering efforts including managing and developing relationships with a range of strategic and scientific collaborators (e.g., CROs, academic institutions, research hospitals, etc) in the advancement of our therapeutic targets.
  • Functional head for Nonclinical and Bioanalytical departments, representing these functional groups at the senior executive, project team and sub-team levels.
  • Provide strong scientific expertise leading the rapid development, validation, and implementation of bioanalytical assays to support non-clinical and clinical studies for the gene therapy programs in development.
  • The incumbent will have experience with GLP compliance, deep understanding of all current bioanalytical, nonclinical regulatory guidance and implementation of industry best practices. They will have knowledge of standard and novel assay platforms and the associated advantages and limitations of these technologies towards enhancing efficiency and scientific quality and regulatory compliance.
  • A key contributor to generating US/Ex-US program specific regulatory filing content in collaboration with the Regulatory Affairs and R&D teams and serve as nonclinical representative / knowledge expert at meetings with regulatory authorities.
  • Incumbant should have experience with running a laboratory faciility to provide input and oversight to the laboratory work that needs to be done to support the gene therapy programs as needed.
  • Design and oversee the execution of safety and tolerability aspects of translational research programs to support clinical stage programs.
  • Develop and maintain world leading expertise and recognition in CNS gene therapies as an emerging therapeutic modality.
  • Advance the concepts and practice of Good Research Practices within a quality culture within Sio Gene Therapies.

Requirements

  • Ph.D. or equivalent advanced degree in relevant scientific discipline (e.g. neuroscience, biochemistry, cell biology)
  • Expertise in in gene therapy, preferably AAV- and lentiviral platforms, for the treatment of neurologic diseases.
  • Experience as a study director, principal investigator and/or study monitor for pharmacology/toxicology studies evaluating gene therapies, preferably for the treatment of Central Nervous System disorders
  • 10 year’s biotech/pharma industry research and development experience preferably with experience in small and mid-size companies
  • Experience with Regulatory Agency interactions (most importantly FDA and EMA)
  • Outstanding collaboration skills required, as this is an extensive matrix role crossing both internal and external stakeholder management. Strong interpersonal, organizational, and multi-tasking skills are a must
  • Advanced written and oral communication skills, specifically, in drafting and review of regulatory documents (e.g., BLA, IND, pre-IND, INTERACT, and expedited programs). This individual will be required to represent the company at all levels of stakeholder engagement, internal and external
  • The individual must be willing to travel as needed, up to 25% of their time
  • The level of this position will be based on the final candidate’s qualifications
  •  

This is an exciting time to join the field of gene therapy in general, and to become a part of Sio Gene Therapies’ fast-growing dedicated team. Sio Gene Therapies is a publicly traded company. We offer an exciting, meaningful and collaborative fast-paced environment with a foundation of sound and rigorous science. Competitive compensation and benefits package can be expected.

All interested applicants should send a cover letter and resume to:  HR@siogtx.com

For questions about working at Sio, please email hr@siogtx.com

Agencies & Recruiters

We maintain a list of approved professional recruiting agencies with which we have signed agreements. Candidates will be considered only when the agency has a signed agreement and Human Resources authorization to present candidates for a specified position(s). Candidates submitted outside of this process are considered unsolicited and will not be considered. Agencies interested in establishing a relationship with Sio may send company information to hr@siogtx.com. A member of the Human Resources team will contact you if we require the services your company offers.

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