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
Neurogene is seeking an Executive Director, Pharmacovigilance to plan and execute drug safety deliverables as part of cross-functional program teams. This role will proactively collaborate from a safety perspective to support the development of genetic medicines, ensuring operational efficiency and compliance with all regulatory safety obligations. This includes identifying and communicating potential emerging or urgent safety issues, creating risk management plans and being accountable to related outsourced partners, organizations and vendors. The role will ensure timely and accurate safety reporting in accordance with applicable regulatory requirements, Good Clinical Practice (GCP) and standard operating procedures (SOP).
Accountabilities and Responsibilities
- Lead strategic and operational activities for the PV department.
- Serve as the medical safety expert for adverse events (AEs) and other safety related information available for investigational products.
- Conduct/Oversee ongoing safety surveillance and signal detection, including independent analysis of safety risks and safety concerns related to the Neurogene products in development.
- Provide medical review, analysis and medical guidance during the case handling and reporting process for serious AEs (SAEs) received for the Neurogene investigational products.
- Ensure all relevant timelines and deliverables for the PV department (overall accountable).
- Ensure adequacy of PV service provider, including excellence and compliance in the operational execution of the services.
- Coordinate the preparation, review and approval, execution and maintenance of Safety Management Plans (SMPs). Ensure clear delineation of roles, responsibilities, process, timelines and compliance and quality metrics between the company and the responsible PV vendor(s).
- Ensure the preparation, review, approval and compliant execution of any Safety Data Exchange Agreements (SDEAs) with partners if applicable.
- Provide medical safety expertise and training to other Neurogene personnel or others, as required.
- Collaborate with the respective Medical Monitor to ensure alignment on PV process, including SAE and signal management processes.
- 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. Maintain knowledge of medical science applicable to the assigned therapeutic areas.
- Monitor industry best practices and changes in global safety regulations and guidelines. Recommends changes and upgrades to existing departmental policies, SOPs and systems to ensure global regulatory compliance.
- Plan, oversee and direct risk management activities for investigational compounds.
- Chair the relevant committees involved in the safety governance for the Neurogene’s products.
- Review and provide relevant safety input on clinical study documents (protocols, Investigator’s Brochures (IBs), Informed Consent Forms (ICFs)).
- Communicate promptly and escalate any potential issues to the relevant stakeholders including executive level.
- Serve as Neurogene business lead for DSPV audits or inspections. Respond and resolve any findings and ensure appropriate corrective action plans.
- Establish DSPV processes and clear roles and responsibilities between Neurogene and the selected PV vendor.
- Provide medical/safety input in the aggregate report preparation (DSURs) as well as ad hoc queries and responses to regulatory authorities for assigned products.
- Prepare and defend PV departmental budget.
- Manage allocated operational resources to support the timely and compliant execution of all PV responsibilities.
Minimum Requirements
- Education
- MD or DO with minimum of 12 years combined experience in pharmacovigilance/drug safety, pharmaceutical industry, and medical practice experience
- Experience
- Gene therapy or Immunology background preferred. Previous leadership and management experience required.
- Licenses or Certifications
- US Licensure and/or Board Certification preferred.
- Knowledge & Skills
- Expert knowledge of international regulatory safety reporting requirements including FDA/ICH guidances related to pharmacovigilance and ICH guidelines.
- Strong clinical background – preferably having had responsibility for patient-care in a clinical setting.
- Expertise in clinical safety assessments, safety signal detection and risk management, including interactions with regulatory authorities.
- Familiarity with ARGUS or other safety databases.
- Experience using coding dictionaries such as Medical Dictionary for Regulatory Activities (MedDRA).
- Strategic thinking orientation combined with focus on compliant and efficient execution.
- Strong written and verbal skills required.
- Possess strong leadership skills with demonstrated ability to solve problems with innovative solutions and collaborative input across functional areas.
- Continuous strong focus on meeting or exceeding expectations in executing deliverables, performance and results.
- 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 with some travel