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.

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

As the project physician for clinical stage gene therapy programs with a special focus on GM1 and GM2 gangliosidosis, you will provide medical leadership and drive the design and execution of the clinical development plan under the guidance of the VP of Clinical Development.  You will be responsible for providing medical and clinical input to the programs and be accountable for the successful and timely delivery of multiple clinical trials.    contribute to the program strategy, regulatory agency interactions and engagement of external experts.


PRIMARY RESPONSIBILITIES

  • Accountable for design, delivery and scientific execution of the clinical studies to the highest standards
  • Key contributor to the clinical development and project strategy
  • Lead the design and execution of clinical study protocols
  • Medical monitor for multiple Phase I-II gene therapy programs
  • Medical/Clinical expert for the programs and liaison with development alliance partners and Trial Investigators to ensure optimal study designs and the timely and accurate execution of the programs
  • Protocol and clinical study report authoring
  • Scientific oversight of clinical data collection, data reviews and interpretation, and data reporting.
  • Contribute to regulatory agency interactions, briefing package and submission document authoring, regulatory reporting, and participate in Agency meetings
  • In collaboration with Medical Affairs, participate in Advisory Board Meetings, Key Opinion Leader engagement, and Patient Advisory board meetings as appropriate

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’ of biotechnology/pharmaceutical experience, ideally with gene therapy/precision genetic medicine in the therapeutic area of CNS and rare disease
  • Knowledge of Pediatric CNS diseases 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
  • Enjoys working in a team environment with proven ability to be effective in a matrixed organization
  • Excellent written and verbal 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

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

As the project physician supporting clinical stage gene therapy programs with a special focus on Parkinson Disease, you will provide medical leadership and drive the design and execution of the clinical development plan under the guidance of the VP of Clinical Development. You will be accountable for providing medical and clinical input to the program and will be responsible for the successful and timely delivery of Phase I-III clinical trials. You will contribute to the program strategy, regulatory agency interactions and external expert engagement.

PRIMARY RESPONSIBILITIES

  • Accountable for design, delivery and scientific execution of the clinical studies to the highest standards
  • Key contributor to the clinical development and project strategy
  • Lead the design and execute clinical study protocols
  • Medical monitor for multiple Phase I-III gene therapy programs
  • Medical/Clinical expert for the programs and liaison with development alliance partners and Trial Investigators to ensure optimal study designs and the timely and accurate execution of the programs
  • Protocol and clinical study report authoring
  • Scientific oversight of clinical data collection, data reviews and interpretation, and data reporting. regulatory submission document authoring and review.
  • Contribute to regulatory agency interactions, briefing package and submission document authoring, regulatory reporting, and participate in Agency meetings
  • In collaboration with Medical Affairs, participate in Advisory Board Meetings, Key Opinion Leader engagement, and Patient Advisory board meetings as appropriate

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’ of biotechnology/pharmaceutical experience, ideally with gene therapy/precision genetic medicine in the therapeutic area of CNS and rare-disease
  • Knowledge of movement disorders 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
  • Enjoys working in a team environment with proven ability to be effective in a matrixed organization
  • Excellent written and verbal communication skills
  • Hands-on, can do attitude
  • Critical thinker
  • Personal credibility and poise

Working conditions (ability to travel ….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 – Remote

COMPANY SUMMARY

Sio Gene Therapies is a biopharmaceutical company committed to developing treatments for severe 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 Sr/Director, Medical and Regulatory Writing, is responsible for determining and driving the medical writing strategy for the clinical programs, and for both the authoring of the documents and the provision of managerial oversight of vendor or contract medical writing when needed.  As a strategic partner to the rest of the R&D team, the incumbent is accountable for the efficient preparation of high-quality, strategically aligned medical writing deliverables that support the clinical development, safety and regulatory requirements of a clinical program

He / she will mitigate risk associated with medical writing and disclosure processes by establishing and maintaining Best Practices and SOPs. This will be an individual contributor role and reports to the VP, Regulatory Affairs.

PRIMARY RESPONSIBILITIES

  • Responsible for authoring, aligning, coordinating and building consistent information and messages across all individual documents within a clinical program, starting with initial strategic plans, continuing through study level documents to final program level deliverables (ie, regulatory submission or publication of key journal articles for a publication plan).
  • Builds convincing clinical or regulatory arguments using logic, analogy and therapeutic area science.
  • Coordinate timelines and processes for preparation, review and QC, approval of regulatory submissions
  • Understands issues affecting the design of clinical development strategy, and understands how study design, data capture and statistical analysis plan design will affect downstream documents.
  • Responsible for ensuring that statements included in the deliverables are accurate and supported by appropriate data.
  • Sets program-level standards (eg, style convention)
  • Liaises with functional groups within and external to R&D to ensure independent and interdependent communication needs and strategies are considered during document development (eg, communicating data in a CSR and regulatory documents to support NDA and Advisory Committee positioning)
  • Accountable for medical writing deliverable quality and ensures work on assigned projects adheres to industry / international standards
  • Drives the development, implementation and communication of Best Practices, SOPs, templates, work instructions, style guides and content guides to ensure efficient preparation of high quality medical writing deliverables.
  • Program forecasting and budgeting in resource planning
  • Building and maintaining collaborative relationships with medical writing partner(s) (CRO, vendor, alliance partner, etc) to ensure an effective, efficient, productive and professional working relationship (defines the scope of work to be outsourced, and is responsible for medical writing vendor

REQUIREMENTS

  • Scientific degree with Post Graduate training in biomedical science is desirable in one of the disciplines related to drug development or business
  • 5+ years of writing experience in the pharmaceutical industry
  • Exceptional English language skills and ability to write and edit complex material to ensure accuracy, clarity, and effectiveness
  • Understanding of statistical principles and medical terminology across a range of therapeutic areas
  • Thorough understanding of basic science and demonstrated ability to cogently and succinctly explain complex scientific concepts
  • Must have experience in writing clinical study reports (CSRs), protocols and Investigator Brochures (IBs), scientific advice documents, IND/BLA briefing documents, and all key regulatory submissions (IND/NDA/BLA)..
  • A solid understanding of the clinical development process, including the documents that are required at each stage.
  • Expert MS Office skills with a special focus on word processing, tables, spreadsheets, presentations, graphics and templates.
  • Knowledge of ICH and CTD guidelines for clinical and regulatory submission documents
  • Ability to think strategically; demonstrated negotiating skills and resourcefulness.
  • Demonstrated ability to manage several projects simultaneously.
  • Strong influencing skills, able to lead without formal authority.
  • Demonstrated ability to make decisions even in the absence of complete information.
  • Experience and insight on external clinical publication practices and standards (ICMJE, AMA, GPP).
  • Excellent organizational and time management skills.
  • Attention to detail.

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 Therapies 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 genetic CNS 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 Director, Global Project Management is responsible for directing the strategic and operational planning and delivery processes within Sio’s global development team(s). This leadership role serves as a partner working closely with the Global Project Leader and project team providing program management excellence to ensure robust cross-functional planning and alignment, facilitate decision-making and drive the implementation, monitoring, and reporting for one or more programs. The Director, GPM must be able to both guide the development of a unified strategic vision and drive the team to successfully execute on the agreed strategy. They will provide content expertise on the timing, costs and resources required to deliver to the defined program strategy, anticipate potential obstacles in the program and facilitate risk: benefit discussions driving the team to a clear direction and path forward.  In this role, the Director GPM will act as an operational leader to help the team achieve established objectives, facilitate governance interactions, and organize the needed tactics to make the project a success. The Director GPM will be responsible for one or more programs with significant complex cross-functional and/or cross-program initiatives within Sio’s pipeline.

Primary Responsibilities 

  • Strategic and tactical partner to the project team leader and line function representatives accountable to establish and deliver aligned cross functional plans across all relevant development functional groups into a cohesive development plan to deliver the agreed TPP and overall program.
  • Work closely with the Project Team Leader to facilitate the elaboration, approval and execution of the global program strategy and facilitate decision-making process through to Sio’s senior leadership team via the company’s governance process
  • Integrate, drive and deliver to ensure a cohesive project plan aligned to deliver an asset to a TPP.
  • Coordinate and drive development process planning activities of the project team including milestone setting, strategic integrated development plans, long range plans, budget inputs and go/no go criteria as appropriate.
  • Ensure transparency and understanding of the approved plan horizontally and vertically throughout the organization. Prepare and manage governance interactions to the Executive Team in partnership with the project leader and ensure timely input of program status/risks/issues throughout the organization.
  • Maintain the overall development plans for assigned program(s). Drive the cross-functional team to deliver to agreed goals.
  • Maintain all project management tools. Facilitate team meetings/agendas/minutes/action items including decision and action logs.
  • Coordinate team goal setting and tracking to ensure adherence to plan and agreed end of year milestones.
  • Manage set up of sub-teams and provide guidance on sub-team management. Participate in subteam meetings as appropriate to ensure alignment to the holistic project plan
  • In an alliance management role, liaise with partners, CMOs, etc. ensuring contractual obligations are met, and a healthy relationship is maintained. Participate in diligence in securing new relationships with partner as needed.
  • Partner with the VP, Project Management and other functional leaders to assess project management processes to ensure best practices are employed for the needs of the company

Requirements

  • Independent creative thinker and enabler requiring minimum oversight
  • A self-starter who is pro-active, motivates, and has tact, diplomacy, and is a team player
  • Excellent leadership skills with a history of delivering in a dynamic environment
  • Demonstrated ability to provide effective project management leadership in terms of setting project plans for the lifecycle of a program from discovery through launch
  • Proven track record of planning and managing complex programs in different phases of development including cross functional deliverables (Research, CMC and Commercial)
  • Solid understanding of the processes in drug development and appropriate regulatory guidelines
  • Strong influencing and interpersonal skills including negotiation, managing meetings and group dynamics, ability to balance concerns of line management with objectives of cross-functional team.
  • Ability to operate and motivate a team in a matrix environment and ability to work with / influence people at all levels in the organization without authority
  • Technical proficiency includes demonstrated proficiency in the use of project planning tools and systems (e.g. Microsoft Project or Smartsheet), resource forecasting, and the use of reporting tools.
  • Demonstrated understanding of program risk management and mitigation in order to simulate the likely obstacles to program progression.
  • Strong organizational skills with the ability to deal with competing priorities; high level of problem-solving capability and business acumen, ability to balance competing priorities and quickly and objectively drive the team towards a path which maximizes value
  • Excellent communication skills (written and verbal communication skills in English)
  • Highly skilled in negotiation, facilitation, and managing matrix team dynamics
  • At least 10 years of experience within one or more functional role(s) in pharmaceutical R&D drug development, biotechnology drug development, or related industry. Experience in gene therapy a plus. At least 5 years of cross-functional program management experience

WORKING CONDITIONS (ability to travel, lifting)

  • Ability to travel up to 25%

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.

Interested applicants should send a cover letter and resume to:  HR@Siogtx.com

Full time position – Remote

Company Summary

Sio Gene Therapies 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 genetic CNS 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

Reporting to the Chief R&D Officer, the S/VP of Regulatory Affairs will be responsible for the global regulatory strategy and worldwide submissions for SIO Gene Therapy’s development programs. The incumbent will provide leadership for the team responsible for planning and executing program applications, both in the US and ex-US, and will hold accountability for regulatory submissions, applicable communications, and GXP compliance across the company’s programs. S/he will focus on corporate goals while responding to the needs of project teams in a highly dynamic fast-moving environment. Beyond that, the VP will assess the current infrastructure and plan to build the team out as business dictates.

Desired Skills and Experience

 The ideal candidate will possess the following mix of personal and professional characteristics:

  • Advanced degree in a scientific discipline (MS, PhD, PharmD) preferred, with at least 10 years of relevant regulatory experience. Gene therapy experience is highly desirable and biologics experience is required.
  • Experience working with Neurology and/or Rare/Orphan Disease groups at the FDA highly desirable. Existing relationships with CBER is desired.
  • Proven success in delivering effective global regulatory strategies in coordination with clinical plans and marketing objectives leading to successful registration. Both IND and BLA experience required. • Ability to prepare, review, and submit high-quality documentation for INDs, CTAs, BLAs, and MAAS, and related filings to regulatory agencies within established timeframes. Responsibilities will include original applications and product maintenance, such as information amendments and annual reports.
  • Ability to lead the development of competitive regulatory strategies that expedite development, maximize the probability of success, and mitigate risks. Ensure regulatory requirements and strategy are understood by the project teams.
  • Expertise in working with global regulatory authorities; specifically communicating and negotiating with FDA and other global regulatory agencies.
  • Understanding of policy, laws, regulations, and guidelines as they apply to Regulatory Agencies for drug development and approval.
  • Proven history of strong leadership and management of a world class regulatory team covering all aspects of Regulatory Affairs, eg CMC, Regulatory Operations, etc.
  • As a member of the R&D leadership team willingness to provide leadership and role modeling for the members of the R&D team and other parts of the organization.
  • A “hands-on”, “roll-up-the-sleeves” when necessary leader that understands the need for involvement within a small company environment while recognizing when to delegate and seek results from the team.
  •  

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.

Interested applicants should send a cover letter and resume to:  HR@Siogtx.com

Full time position – Remote

Company Summary

Sio Gene Therapies 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 genetic CNS 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 Director/Sr. Director of Biostatistics will provide statistical support to the design and analyses of clinical trials, including the development of statistical models, statistical analysis plans, project management, report preparation, and advising/leading other contract and in-house project statisticians and statistical programmers.  You will function as the Biostatistics Project Lead across multiple protocols/projects at both the IND and BLA level and work closely with other clinical development staff and participate in regulatory agencies interactions as required.  The Director/Sr. Director will lead the effort to provide adequate biostatistical support for all SioGTX programs.

Primary Responsibilities 

  • Collaborate with the clinical and project teams on the development and implementation of statistical aspects of research protocols including, but not limited to, defining study objectives, randomization schemes, sample size assessments, efficacy and safety endpoint assessments, and data review.
  • Performs statistical analyses of clinical research data (demographic and other baseline characteristics, measurements of treatment effect/compliance, efficacy and safety evaluations, pharmacokinetic/bioanalytical evaluations, interim and final analyses, etc.)
  • Interface with external resources (CROs, KOLs, Steering Committees, etc.) as the program statistician for Sio
  • Investigates novel approaches for designing and analyzing clinical research projects and makes strategic recommendations accordingly
  • Provide input into timelines and ensure that timelines for biostatistics deliverables or milestones are met
  • Develop statistical analysis plans and lead the review and approval of these plans
  • Coordinate the development of statistical programming specifications to summarize clinical trial results and ensure consistent and accurate summarization of clinical data extracts and data displays
  • Performs statistical analyses including hypothesis testing and modeling
  • Interacts with Medical Writing to provide tabular and written summaries of analyses and statistical methodology and data inferences for clinical study reports
  • Creates integrated databases for submissions to regulatory authorities
  • Line manage /oversee the work of in-house/contract statistical programmers

Requirements 

  • PhD or MS in Biostatistics with 4-8 years of pharmaceutical or biotechnology industry experience
  • Ability to synthesize and communicate results in graphic, oral, and written reports/ presentations
  • Experience with statistical methods commonly used in the analysis of clinical trial data and experience with statistical software packages such as SAS, R, JMP, and Python
  • Understanding of the spectrum of drug development from IND enabling through late-phase development, with experience in rare diseases and gene transfer therapies as a plus.
  • Understanding of GCP, ICH, and FDA guidelines and regulations applicable to conducting clinical research
  • Good organizational skills with the ability to adapt and adjust to changing priorities
  • Ability to work creatively and cooperatively with cross functional team members

Working Conditions

  • We are a virtual company, and this position will be remote, but occasional (20%) travel required for company/other meetings. Access to reliable Wi-Fi service is required
  • Able to work upright and stationary for typical working hours
  • Ability to use and learn standard office equipment/technology with proficiency is required
  • Able to prioritize and handle multiple projects in a sometimes stressful environment

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.

Interested applicants should send a cover letter and resume to:  HR@Siogtx.com

Full time position – Remote

Company Summary

Sio Gene Therapies 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 genetic CNS 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/Sr. Director, Process Development and Manufacturing. Reporting to the Vice President, Process Development and Manufacturing, CMC. The candidate will be responsible for phase appropriate CMC development and manufacturing oversight, identifying, and implementing necessary process improvements, management of activities at contract development and manufacturing organizations (CDMOs), as well as authoring/review of relevant submissions to regulatory agencies.

Primary Responsibilities 

  • Oversight of cross functional teams to ensure clinical and commercial readiness for Sio programs internally and externally.
  • Development and implementation of phase appropriate CMC development and manufacturing activities from early clinical to commercial stages.
  • Identification of necessary process improvements, and management of development/ implementation of process improvements at external manufacturing sites.
  • Management and oversight of proper execution of manufacturing runs at external CDMOs.
  • In coordination with Supply Chain, Clinical Operations, Project Management and external CDMOs, management of manufacturing needs and scheduling of manufacturing runs in accordance with program timelines.
  • Interaction as process development and manufacturing SME with internal and external parties, including Program Management, Analytics, Regulatory Affairs, Quality Assurance and Supply Chain.
  • Responsibility to develop, author, review, and/or approve Standard Operating Procedures, specifications, reports, regulatory filings, or other controlled documents, as needed.
  • Act as process and technical expert during regulatory inspections, regulatory agency meetings, and in creating responses to agency questions
  • Review and approve BMRs, SOPs and Quality Systems (Change Controls, Deviations, CAPAs) at external CDMOs as process SME

Requirements 

  • S or equivalent in Chemistry, Biological Sciences, Engineering or related discipline, with 15+ years of experience; Ph.D. with 8+ years of experience.
  • Knowledge in interacting and coordinating efficiently with Analytics, Regulatory Affairs, Program Management and Quality Assurance.
  • Expertise in early development as well as late stage/commercial biologics or vaccines, preferably in gene therapy.
  • Experience managing external contract organizations.
  • Excellent written and oral communication and collaboration skills across levels and functions.
  • Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
  • 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.

WORKING CONDITIONS

  • Up to 20% travel to contract organizations within the US and to Europe required.
  • Remote work location expected

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.

Interested applicants should send a cover letter and resume to:  HR@Siogtx.com

Full time position – Remote

Company Summary

Sio Gene Therapies 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 genetic CNS 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

  • Responsible for managing the submission of IND’s and NDA’s for development practices.
  • Represent regulatory at internal and external development project meetings.
  • Organize and coordinate submissions in accordance with applicable regulations and guidance
  • Conduct completeness, scientific accuracy and ease of review of the submissions.
  • Prepare and review annual reports and liaise with the review branches of FDA throughout the review process.
  • Interface with clinical and pre-clinical groups, Regulatory CMC and other appropriate group within the company as required.
  • This position is an individual contributor, reports to the Sr. Director, Regulatory Affairs and is remote (in keeping with company policy).

Primary Responsibilities 

  • Proactively participate in design of US, EU, and Canada regulatory strategies for the development of gene therapy products for rare diseases
  • Oversee and manage the preparation of required documentation for regulatory submissions (including but not limited to pre-IND, IND/CTA, BLA/MAA and PIPs). This will require strong regulatory knowledge and experience, cross-functional interactions, excellent project/time management and writing skills, and an understanding of the underlying science.
  • Collaborate across the project teams (nonclinical, clinical, CMC, regulatory, quality) to ensure seamless integration and consistent messaging in submissions
  • Evaluate the adequacy of the content of regulatory submissions and identify deficiencies requiring further resolution.
  • Assist and train in Regulatory submission and review activities.
  • Prepare responses to requests from Health Authorities and acts as a key liaison with the FDA to schedule and lead meetings and carry out discussions and negotiations to solidify strategy and resolve issues.
  • Drive adherence with latest Health Authority requirements and guidelines.
  • Perform regulatory intelligence activities – monitor regulation/guidance changes and competitor trends/strategy
  • Communicates with outside vendors and consultants (i.e., CRO’s) as needed.

Requirements 

  • Education/Experience: Bachelor’s Degree in a life sciences discipline required, with advanced degree (Masters, Pharm.D., Ph.D) preferred but not required.
  • At least 5 years of relevant regulatory affairs experience required, preferably in biotechnology, ideally in gene therapy/ATMP applications.
  • Knowledgeable in ICH, FDA, EMA, and WHO regulations/guidelines.
  • Experience with EU CTA submissions preferred.
  • Experience with CTD/eCTD preparations required.
  • Experience in providing regulatory strategic input, regulatory science writing, and document management.
  • Ability to think strategically; demonstrated negotiating skills and resourcefulness.
  • Demonstrated ability to manage several projects simultaneously.
  • Strong communication skills.
  • Demonstrated ability to work collaboratively across the project team to drive efficient decision-making and execution of strategy.
  • Excellent organizational and time management skills.
  • Strong attention to detail.

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.

Interested applicants should send a cover letter and resume to:  HR@Siogtx.com

Full time position – Remote

Company Summary

Sio Gene Therapies 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 genetic CNS 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

Reporting to the Senior Director, Regulatory Affairs CMC, Sio Gene Therapies is seeking a highly motivated Associate Director Regulatory Affairs CMC. This role is responsible for defining regulatory CMC strategy and for planning and the preparation of global CMC regulatory submissions for INDs and CTAs  to achieve timely approvals.  Responsibilities include actively leading the development and implementation of CMC regulatory strategy in close collaboration with CMC teams, identifying and assessing regulatory risks, leading CMC Health Authority interactions, and providing regulatory CMC leadership on cross functional teams and with contract manufacturing organizations. 

Primary Responsibilities 

  • Accountable for strategy, planning, preparation, review and approval of global regulatory CMC submissions and responses to Health Authority questions
  • Leads cross-functional teams responsible for the preparation of submissions and responses to Health Authority CMC questions for assigned projects/products
  • Ensures effective communication of CMC regulatory strategy, risks, and overall plans to leadership and teams
  • Lead all regulatory CMC related interactions, resolution of CMC issues and negotiation of CMC approvals with health authorities in all regions
  • Act as Regulatory CMC Lead for assigned programs
  • Ensure that CMC-related regulatory submissions are complete, well written, and meet all relevant requirements
  • Assess proposed technical changes and provide strategic regulatory guidance to enable implementation
  • Drive adherence to CMC regulatory guidelines relevant for the development of gene therapies
  • Participate in regulatory intelligence activities as they pertain to global CMC regulations and guidance, and provide regulatory advice to program teams

Requirements 

  • Bachelor’s degree or equivalent with 7+ years experience in biotech/ CMC industry with at least 3 years in Regulatory CMC
  • Strong working knowledge of relevant FDA/EMA/health authority regulations and guidelines (as well as relevant ICH guidelines) for biotechnological/gene therapy products
  • Extensive experience with direct communication and negotiation with regulatory agencies on CMC topics
  • Direct experience preparing Regulatory applications in CTD format
  • Strong knowledge of biopharma industry and technical knowledge with end to end CMC biologics development
  • Communicates clearly and precisely in both written and verbal communications with internal and external partners at all levels of the organization
  • Ability to work both independently and collaboratively in a fast-paced, matrixed, team environment consisting of internal and external team members; maintaining strong business partner relationships

 

WORKING CONDITIONS (ability to travel, lifting)

  • This role is open to remote work locations.
  • Up to 30% travel to contract organizations within the US and to UK/Europe required.

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.

Interested applicants should send a cover letter and resume to:  HR@Siogtx.com

Full time position – Remote

Company Summary

Sio Gene Therapies 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 genetic CNS 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 Senior Manager/Manager, Supply Chain, for Sio’s AAV and Lentiviral gene therapy programs. Reporting to the Head of Supply Chain, the Senior Manager/Manager of Supply Chain will be responsible for the shipment, returns, and storage of Clinical Supply as well as storage and shipment of R&D material.

Primary Responsibilities 

  • Manage depot/site distribution/stocking requirements, as well as expiration and retest date requirements.
    • Proactively manage Clinical Trial Material and ancillary supplies inventory.
    • Formal documented management of materials which are near or past expiry.
  • Managing Importation/Exportation requirements for materials and drug products.
  • Support shipment and storage of Clinical and R&D material from internal and external sources.
  • Work with Clinical Operations, Quality, and Manufacturing to manage the distribution of clinical materials to sites and depots.
  • Create supply plans to meet the demands of multiple international clinical trials.
  • Oversee the execution of secondary packaging at packaging vendors and depots for global clinical studies and programs to ensure timely release.
  • Work with external distribution partners to ensure raw material levels are stocked appropriately based on manufacturing demand to meet the production schedule for all manufacturing sites.
  • Oversee Quality issues related to the clinical supply chain, including deviations, CAPA, and change control.
  • Provide support to the CMC team and closely work with Clinical Operations, Quality, and Regulatory Affairs to develop clinical supply requirement plans and support supply chain activities with internal organizations and external vendors.
  • Support the creation and update of labeling and kitting for study requirements, perform and report demand and forecast planning, and develop distribution plans to/from clinical sites.
  • Prepare regular inventory, distribution, and shipment reports.
  • Support implementation of IVRS and MRP/Inventory Management systems.

Requirements 

  • B.S. or equivalent in Chemistry, Biological Sciences, Pharmaceutical Sciences or related discipline.
  • At least 5+ years in Supply Chain Management, with some exposure to gene therapy products preferred, in a regulated environment in the biotech industry.
  • Demonstrated experience in the set-up, management, and close-out of phase 1-4 clinical trial supply programs.
  • Demonstrated experience across the spectrum of clinical supply activities, including packaging, labeling, distribution, returns, accountability, and destruction.
  • Knowledge of GCP, cGMP and GDP regulations pertaining to the procurement, manufacture, and distribution of clinical supplies.
  • Experience of GMP and GDP operations and a proven track record of successfully contributing to cross-functional teams.
  • Strong knowledge of quality systems, such as CAPA, deviations, change controls, and working in a regulated environment.
  • Ability to work independently and collaboratively, as required, 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.
  • Strong organizational and self-management skills.
  • Demonstrated planning, organization, and time management skills, including the ability to support and prioritize multiple projects.
  • Excellent communication and collaboration skills across levels and functions.
  • Must be proficient in the use of Microsoft software (Word, Excel, PowerPoint, MS Project, Excel).
  • Up to 20% travel may be required.
  • APICs or similar supply chain management certification, preferred.

WORKING CONDITIONS (ability to travel, lifting)

  • Remote work location with occasional office presence required.

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.

Interested applicants should send a cover letter and resume to:  HR@Siogtx.com

Full time position – Remote

Company Summary

Sio Gene Therapies 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 genetic CNS 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 Manager/Senior Manager, Quality Control, to support our gene therapy program. Reporting to the Associate Director, Analytical Development and Quality Control, the Manager/Senior Manager, Quality Control will be responsible for organization, management, and tracking of testing related to LVV and AAV-based gene therapy programs, including document management and data trending.

Primary Responsibilities 

  • Support the implementation of phase-appropriate testing strategies for viral gene therapy vectors.
  • Liaise with contract testing organizations performing assay development as well as product release testing.
  • Managing and reviewing controlled documentation related to QC testing.
  • Support technical transfer between laboratories, qualification/validation of assays and QC activities for material release.
  • Managing and tracking the performance of stability programs for gene therapy products.
  • Management, trending, and organization of analytical data for presentation and to inform decisions.
  • Coordination with internal and external parties, including Program Management, Process Development, Manufacturing, Supply Chain, Quality Assurance, Regulatory Affairs and Clinical Operations.
  • Identification and communication of risks in assay performance and their mitigation.
  • Responsibility to develop, author, review, and/or approve Standard Operating Procedures, specifications, regulatory filings, or other controlled documents as needed.

Desired Skills and Experiences

  • B.S. in Chemistry, Biological Sciences, Engineering, or related discipline with 8+ years of experience; M.S with 6+ years of experience; Ph.D. with 3+ years of experience preferred.
  • Expertise in gene therapy projects desired.
  • Working knowledge of analytical technologies employed in gene therapy (ddPCR/qPCR, HPLC, LC/MS, cell-based assays, ELISA, among others).
  • Experience managing, trending, and analyzing analytical data is essential.
  • Familiarity with assay development, qualification, and validation activities is essential.
  • Expertise in quality control, preferably in late stage/commercial pharmaceutical projects.
  • Experience managing contract organizations.
  • Expertise 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 to “rolling up their sleeves” and executing the ever-changing 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.

Interested applicants should send a cover letter and resume to:  HR@Siogtx.com

Full time position – Remote

Company Summary

Sio Gene Therapies 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 genetic CNS 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 Director, Clinical Operations is accountable for the leadership, strategic planning, oversight, execution of clinical operations and the management of staff responsible for our gene therapy products. The individual must have the ability to work independently and as an effective and engaged team member in a dynamic, fast-paced environment.

Primary Responsibilities 

These may include but are not limited to:

    • Build out and oversee the Clinical Operations function, processes and all activities related to execution of clinical studies and programs in accordance with regulatory guidelines.
    • Develop efficient, scalable system approaches to planning and implementing clinical trial operations that effectively integrate clinical operations and other functional areas.
    • Recruit, motivate and provide oversight for all in-house clinical operations and external department staff and resources associated within clinical operations, CRO’s and vendors.
    • Direct the successful execution of all clinical trials, programs, timelines, and clinical milestones.
    • Identify and resolve clinical operations issues related to data management, monitoring, timelines, drug distribution, safety assessment, regulatory compliance, and timely review of trial master files, etc.
    • Manage all budgets, contracts, agreements, vendor payments and processes to conduct clinical trial programs in an effective manner.
    • Oversee data collection activities for all clinical programs: CRF, SAE assessment, queries, and follow-up, annual reports, investigator brochures, BLA, etc.
    • Perform other duties as assigned.

Requirements

  • BS in a scientific discipline with 10+ years of Clinical Operations line management experience (an equivalent combination of education and experience may be considered). MS, PharmD or PhD is preferred.
  • Extensive background in pharmaceutical and biotech clinical research and development. Experience with cell or gene therapy clinical programs is highly desirable.
  • Proven history of strategic drug development, demonstrated through comprehensive clinical trial design and execution and prior regulatory accomplishments (NDAs/INDs).
  • Proven experience hiring, leading clinical operations teams, and overseeing their career growth skills.
  • Experience managing a rapidly changing organization and integrating new personnel is essential, as well as ability to evaluate and resolve complex problems.
  • Demonstrated experience in CRO and vendor management to support global clinical trials, including excellent senior leadership, project management, budgeting, and negotiation skills, required.
  • Strong knowledge of FDA/EMEA regulations and GCP/ICH guidelines regarding clinical trial management.
  • Excellent verbal and written communication skills and ability to relay vision/strong sense of department organization, processes, and change to management and staff.
  • Travel may be required up to 15%.

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.

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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