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

The Director of Scientific Communications is a critical team role with multi-faceted responsibilities and a high-level of accountability. This role delivers publications and medical education initiatives, scientific content development for a broad range of audiences, scientific onboarding and continuous training for R&D, and engagement and relationship building with both internal colleagues and external experts.  Essential to the role is the ability to effectively work within a fast-paced early start-up environment with cross functional partners.

Primary Responsibilities 

  • Direct accountability for the execution of strategic publication and conference plans for scientific, clinical, and real-world evidence for a broad audience including healthcare professionals, payers, and patients
  • Collaborate in building medical and scientific platforms
  • Responsible for development of slide decks for educational programs, congress symposia, advisory boards, and other key external scientific communications (standard response letters, FAQs, etc.)
  • Drive internal training on scientific and investigational product information
  • Closely monitor the published literature and follow medical developments and competitive landscape within Sio’s therapeutic areas and disseminate new information
  • Engage and collaborate with internal colleagues and external experts (healthcare professionals, payers, advocacy groups), investigators, journals, conference organizers and external bodies to deliver strategic publication and communication activities to develop and maintain relationships and gather insights
  • Responsible for ensuring all publications and scientific communications are aligned with the medical strategy, scientifically accurate and fair balanced, and in compliance with Sio’s policy and external publication guidelines
  • Responsible to work in close collaboration with the V.P. Medical Affairs to execute the strategic efforts of Medical Affairs in support of pre-launch products
  • Manage multiple projects and activities with minimal supervision by the VP Medical Affairs

Requirements

  • A minimum of an advanced life sciences degree, required. PhD or PharmD, preferred
  • 8+ years of relevant experience working directly in the Pharmaceutical/Biotechnology industry with at least 4 years of experience in Medical/Scientific Affairs
  • Broad understanding of drug development process, clinical research, and clinical trial design
  • Strong understanding of pharmaceutical industry laws, FDA and international regulations, and guidelines regarding medical information, scientific material review & management, and scientific communications
  • Demonstrated ability to establish and maintain professional relationships with external experts, investigators, journal editors and publishers and professional organizations
  • Demonstrated ability to present complex scientific and medical information to a range of audiences including scientists & researchers, patient advocates, key opinion leaders, payers, and policy influencers
  • Experience in the evolving healthcare system, with payers, IDNs or both
  • Ability to create new ways to visualize the scientific narrative and develop slide decks to support Clinical and Medical Affairs
  • Ability to effectively manage multiple stakeholders and projects to within budget
  • Scientific knowledge and experience in rare disease, neurology, gene therapy preferred
  • Experience in supporting the launch of multiple transformative drugs; preferably in the rare disease space
  • Proactive individual with ability to thrive in a fast-paced, entrepreneurial, dynamic environment with high performing colleagues
  • Ability to work independently, analyze and work with attention to detail, process and prioritize complex information, and problem solve
  • Microsoft Office (Word, Excel, PowerPoint, and Outlook) proficiency and the ability to learn new systems

Working Conditions (ability to travel)

  • 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 – Durham, NC or 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, Technical Administration.  Reporting to the Director of Bioanalytical, the Manager, Technical Administration will work closely with Early Development team Directors and be responsible for managing Contract Research and Testing Organization activities supporting clinical and nonclinical analytical development and nonclinical studies. 

Primary Responsibilities 

Include, but are not limited to:

  • Management of the Statement of Work or other contracts, from generation of initial quote through data delivery to team.
  • Serve as an interface between clinical / nonclinical sites and assay development to ensure that protocols, sample collection and processing procedures, and other activities defined in contracts are consistently defined, controlled, and executed.
  • Working with Clinical Operations team to oversee shipment/receipt of samples by analytical labs, maintaining data delivery timing expectations.
  • Working with Early Development team to oversee design, study execution, sample collection and analysis, and report generation are completed on time and according to protocol.

Requirements 

  • B.S. or M.S. in the life sciences, with 3-5 years of experience working with Contract Research and Testing Organizations
  • Experience with conducting and managing studies under quality control (GLP, CAP/CLIA, etc)
  • Excellent communication skills (written and verbal communication skills in English)
  • Skilled in negotiation, facilitation, and managing matrix team dynamics
  • Experience with assay development and troubleshooting and validation (ELISA, qPCR, LC-MS/MS, Potency Assays, ddPCR, Enzymatic activity assays, Neutralizing antibody assays) preferred.
  • Experience authoring of quality-controlled documents such as procedural SOP preferred.

Working Conditions

  • Ability to travel (10-25%)

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

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

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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