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Director, Safety Scientist and Operations
Remote

Company Background

The mission of Neurogene is to treat devastating neurological diseases to improve the lives of patients and families impacted by these rare diseases. Neurogene is developing novel approaches and treatments to address the limitations of conventional gene therapy in central nervous system disorders. This includes selecting a delivery approach to maximize distribution to target tissues and designing products to maximize potency and purity for an optimized efficacy and safety profile. The Company’s novel and proprietary EXACT transgene regulation platform technology allows for the delivery of therapeutic levels while limiting transgene toxicity associated with conventional gene therapy. Neurogene has constructed a state-of-the-art gene therapy manufacturing facility in Houston, Texas. CGMP production of NGN-401 was conducted in this facility and will support pivotal clinical development activities. This transformative work is driven by our highly collaborative people who come together each day to bring us closer to achieving our mission. As an employee of Neurogene, you will be part of building a culture that honors patient and caregiver mindsets and nurtures innovation, creative problem solving and a strong sense of purpose.

 

Position Overview

The Director, Safety Scientist and Operations focuses on ensuring safety and regulatory compliance across Neurogene’s development programs, managing reporting, risk management planning and safety data exchange agreements. This role is responsible for implementing and maintaining safety systems, SOPs and protocol for real-time data access and operational efficiency. In addition, this role will support audits, inspections and adherence to safety regulations, while partnering cross-functionally to ensure safety during clinical trials. Finally, Safety Science and Operations will be accountable for developing safety protocols and risk assessments.

 

Accountabilities and Responsibilities

  • Responsible for efficient and compliant execution of the Drug Safety/Pharmacovigilance (DSPV) activities across all Neurogene development projects, under supervision of the PV Head.
  • Support the organization of DSPV process through a set of Standard Operating Procedures (SOPs) with the approval and guidance of the PV Head.
  • Track and ensure compliance with all PV obligations.
  • Support the review of ongoing safety information (individual AE reports) and ensure compliance to process and deadlines.
  • Review safety related sections of clinical development documents (e.g., safety reporting in protocol, alignment of informed consent with investigator brochure).
  • Monitor incoming safety information from clinical trials and other sources (such as literature) to prepare signal detection activities.
  • Provide operational support to study teams for DSPV activities (e.g., investigator safety training, processing of (Serious) Adverse Events ((S)AEs) per protocols, supporting safety assessments activities).
  • Attend routine and ad-hoc meetings related to DSPV and generate/review minutes, as required.
  • Support the development of Safety Management Plans (SMPs) with PV vendors for the approval by the PV Head. Responsible for the compliant execution of the SMP and PV vendor oversight through regular communications/meeting and review of quality and compliance metrics.
  • Support the development of Safety Data Exchange Agreement (SDEA) with partners when appropriate. Responsible for ensuring the compliant execution of the SDEA obligations.
  • Support other Neurogene functions including Regulatory and Clinical Development in order to maximize efficient and compliant DSPV activities including safety reports distribution or submission to Health Authorities.
  • Escalate promptly non-compliance issue or potential safety issues to the PV Head. Prepare as needed material require to support the decisions of the safety governance bodies.
  • Collaborate with other functions (e.g., Medical Directors) or PV Vendors on signal detection process and in preparing aggregate reports (e.g., Development Safety Update Reports (DSURs) as well as supporting development New drug Application (NDA)/Biologics License Application (BLA) Safety Updates, IND (Investigational New Drug) safety reports, investigator safety communications, safety communications with license/development partners, safety sections of clinical study reports (CSRs), and other safety reports, as necessary, under supervision of the PV Head.
  • Act as Quality representative for the PV function. Support the PV Head during PV audits or inspections of DSPV activities. Support the PV Head during PV vendor selection or external PV audits.
  • Participate in training activities (e.g., create training material, provide live trainings) on DSPV topics for other relevant Neurogene functions.
  • Remain current regarding knowledge of relevant DSPV regulations and guidance (e.g., International Council for Harmonisation (ICH) , United States (US) Food and Drug Administration (FDA), European Union (EU) and local/regional) required for Neurogene. Review new and changed DSPV regulations, share learnings with impacted functions and lead other activities to ensure regulatory compliance (e.g., SOP updates).

 

Minimum Requirements

  • Education
    • Bachelor’s degree in a healthcare field (e.g., nursing, pharmacist)
  • Experience
    • Significant DSPV experience in clinical or post-marketing settings; minimum of five (5) years or equivalent of DSPV clinical experience
  • Licenses or Certifications
    • US Licensure and/or Board Certification preferred.
  • Knowledge & Skills
    • Clear knowledge of ICH guidance and country specific regulations and guidance (e.g., FDA, EMA); proficient in technical safety systems (PV Databases) and medical coding (Medical Dictionary for Regulatory Activities (MedDRA))
    • High level of interpersonal skills and ability to work effectively in a cooperative and collaborative manner across functional teams both internally and externally
    • Excellent project planning and implementation skills in a cross-disciplinary and multi-cultural team, including detail-oriented problem solving
    • Excellent oral and written communication skills
    • Flexibility in a changing environment (e.g., priorities organizational needs)
    • Ability to track and measure performance against defined metrics.
    • Self-starter with high degree of energy, independence, initiative, and self-motivation, as illustrated by the ability to instill a sense of pace and urgency into the team.
    • Someone who moves fast and decisively in a balanced manner, with a passion for the growing company.
    • Passionate, collaborative, creative, willing to take prudent risks, and motivated by the creation of a company focused on transformative treatments for patients and their families.
    • Ability to track and measure performance against defined metrics.
    • Self-starter with high degree of energy, independence, initiative, and self-motivation, as illustrated by the ability to instill a sense of pace and urgency into the team.
    • Someone who moves fast and decisively in a balanced manner, with a passion for the growing company.
    • Passionate, collaborative, creative, willing to take prudent risks, and motivated by the creation of a company focused on transformative treatments for patients and their families.
  • Work Environment 
    • Remote, office-based work with some travel
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