Regenxbio

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description The (Sr.) Director, GCP & GLP QA will ensure robust quality assurance systems and procedures are in place to cover REGENXBIO’s pre-clinical activities through clinical trial operations. You will also ensure non-clinical and clinical study execution are compliant with applicable GLP, GCLP, and GCP regulatory requirements as well as regulatory compliance of both internal functions and outsourced activities through oversight of audit activities, utilizing internal and external resources. You will have the opportunity to interface and collaborate with representatives from Clinical Operations, Biometrics, Clinical Development, Regulatory Affairs, Bioanalytical and Preclinical functions. - Develops/improves quality programs and procedures to promote, facilitate, and ensure compliance with domestic and international regulatory and industry standards and implement risk-based methodologies to improve efficiencies - Authors and/or reviews and approves Standard Operating Procedures (SOPs) - Reviews/approves or audits clinical and regulatory documentation and other clinical data to ensure accuracy and data integrity for GCP, GLP and GCLP activities as required - Evaluates internal systems and external clinical sites and vendors to determine acceptable compliance to applicable regulations and guidelines - Provides QA support for risk assessment and remediation, and identification and investigation/CAPA of Critical Quality Issues as needed - Oversees/approves non-clinical and clinical supplier and site audit/assessment schedules and facilitates the selection of contract auditors to support the clinical auditor program, as required and per defined budget - Participates in or leads internal and vendor audits to ensure patient safety and data integrity - Oversees clinical quality event and CAPA process - Develops and delivers training on good clinical practice concepts and specific GCP procedures - Represents QA at internal clinical and GCLP team meetings - Supports key quality processes, metrics and indicators to measure trends and improve key quality determinants of GCP and supporting GxP operations - Effectively communicates progress and issue resolution to appropriate internal/external stakeholders - Stays up-to-date with current regulatory changes and industry trends and translates new requirements back to the company’s policies and procedures - Facilitates/lead QA activities for GLP/GCP regulatory inspection management - Promotes a culture of quality and operational excellence through leadership of clinical quality function and partnering with other departments throughout the organization - Plans, resources, and manages staff to ensure efficient operations and encourage development of capabilities - Must be able to travel up to 10-20% of time Qualifications - BS, preferably in a biological science - Must have direct job experience in a Clinical QA or GLP QA role - Extensive experience conducting and overseeing audits - Extensive knowledge of FDA and EU regulations as well as ICH guidelines - Minimum of 10 years of experience in a Quality Assurance/Quality Systems/Clinical QA position in biopharma / biologics / cellular therapy / gene therapy in a regulated environment - Excellent interpersonal skills and ability to effectively interact with and influence different functional groups at multiple levels of the company - Ability to interpret regulations and practically apply them to procedures - Excellent oral and written communication skills for effectively interfacing with internal and external organizations - Strong project management skills - Ability to manage multiple priorities with aggressive timelines and changing priorities - Must have excellent attention to detail - Possesses strong critical and logical thinking - Basic proficiency in MS PowerPoint, Excel and Word Benefits - Market-competitive base salary - Annual performance-based bonus program - Stock grants at all levels - Health, dental, and vision insurance - Retirement plan with 401(k) match - Summer hours - Estimated compensation range for this role is $190,000 to $330,000 annually

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description As Associate Director, Commercial Insights & Strategy, you will serve as a strategic thought partner and analytical expert to the Commercial, Portfolio, and cross-functional teams. By connecting competitive intelligence, market research, and forecasting to shape marketing strategy, field effectiveness, and launch readiness, you will advance REGENXBIO’s insights capabilities. Additionally, you’ll evolve the current insights function from early-stage monitoring to a forward-looking commercial engine that informs brand planning, market development, and the design of the commercial insights and technology infrastructure. - Lead development and communication of integrated insights across teams to guide near- and long-term strategy. - Synthesize market research, competitive intelligence, and field feedback into clear, actionable insights that inform brand planning, launch readiness, and marketing strategy. - Help shape branding, messaging, and market metrics including awareness, perception, and adoption intent. - Lead proactive monitoring of the program, gene therapy, and rare disease landscapes, including REGENXBIO licensees and competitors, to inform commercial strategy and brand planning. - Coordinate and facilitate competitive intelligence collection at major medical conferences in partnership with Medical Affairs and Commercial teams, ensuring timely debriefs and actionable insights. - Work with cross-functional partners to refine forecasts and scenario planning to inform strategic decisions. - Integrate epidemiology, market dynamics, and insights data to support portfolio and program-level assumptions. - Manage vendor partnerships for market research, analytics, and CI to ensure high-quality, actionable deliverables on time and within budget. - Support development of a scalable insights and analytics technology stack for commercial use. - Engage with senior stakeholders across Commercial, R&D, and Corporate Development to communicate insights and recommendations that influence decision-making. - Present findings and implications in clear, concise formats tailored to different audiences. - Travel up to 25%. It is imperative that REGENXBIO employees embody our core values by working collaboratively, building strong relationships and using clear communication to meet shared objectives. Qualifications - Bachelor’s degree required; advanced degree (MS, PhD, MBA) in life sciences, business, or healthcare field preferred. - 7+ years of experience in commercial insights, market research, competitive intelligence, forecasting, or marketing within the biotech or pharmaceutical industry. - At least 2 years of experience supporting or leading activities related to product launch preparation, including market assessments, forecasting, brand strategy, or field enablement. - Strong understanding of drug development and commercialization processes, ideally within rare disease or gene therapy. - Demonstrated ability to integrate primary (qualitative and quantitative) and secondary research into clear strategic recommendations. - Excellent written and verbal communication skills with the ability to influence and engage stakeholders across all levels of the organization. - Track record of cross-functional collaboration with marketing, medical, market access, and field teams. - Highly organized self-starter with strong analytical and problem-solving skills and comfort operating in ambiguity. - Proficient with Excel, PowerPoint, and CI/MR databases and tools such as Citeline, BioMedtracker, EvaluatePharma, PubMed, and clinicaltrials.gov. - Experience managing vendors and external partners to deliver high-quality insights and analyses on time and within budget. - Experience in gene therapy, retinal diseases, or rare diseases strongly preferred. Benefits - Comprehensive and competitive benefit & compensation package. - Market-competitive salaries. - Annual bonus program. - Education assistance. - Retirement plan with employer match. - Stock options at all levels. - Summer hours and more! The estimated compensation range for this role is $170,000 to $225,000 annually. The actual salary offered to the final candidate depends on a number of factors such as relevant work experience, skills, education, and years of experience. In addition, professional development is important to us. By joining our team, you’ll have the opportunity to be exposed to challenging projects and have access to development resources to help you grow personally and professionally.