The posting
SHIFT:
Day (United States of America)
Seeking Breakthrough Makers
Children’s Hospital of Philadelphia (CHOP) offers countless ways to change lives. Our diverse community of more than 20,000 Breakthrough Makers will inspire you to pursue passions, develop expertise, and drive innovation.
At CHOP, your experience is valued; your voice is heard; and your contributions make a difference for patients and families. Join us as we build on our promise to advance pediatric care—and your career.
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A Brief Overview The Children's Hospital of Philadelphia (CHOP) is dedicated to advancing the development and clinical translation of genome editing therapies. The Senior Executive Director of Regulatory Affairs for Advanced Genetic Medicines provides strategic leadership for regulatory affairs across a diverse development portfolio, enabling the efficient advancement of innovative medicines while ensuring compliance with worldwide regulatory standards.
This individual serves as a key R&D leader, shaping portfolio strategy, regulatory policy, and organizational capabilities. This role is responsible for overseeing the Institution's regulatory activities related to gene editing and other advanced genetic therapies. In addition, they will support clinical research and product development efforts. This individual is part of a team responsible for regulatory advice and strategy related to investigational products and assets.
The candidate is expected to provide regulatory strategy and operational leadership for investigational therapies, including INDs, BLAs, and associated interactions, and ensure compliance with FDA regulations and institutional policies. This position serves as a key regulatory partner to investigators, sponsors, and cross-functional teams to facilitate efficient development and conduct of clinical trials. Success in this role requires extensive experience in regulatory affairs and FDA interactions, strong project management expertise, advanced knowledge of FDA regulations and ICH/GCP guidelines, along with demonstrated leadership and communication skills in complex research environments
What you will do
- Lead regulatory planning from preclinical development through marketing authorization and lifecycle management for advanced genetic therapies, such as gene editing products
- Provide strategic guidance for INDs, CTAs, BLAs, MAAs, and post-approval activities
- Contribute to executive decision-making regarding development strategy and regulatory risk
- Serve as primary regulatory liaison with the FDA and other regulatory agencies for submissions, communications, and inquiries
- Assist research teams to navigate the pre-IND and IND filing process for Phase I/II human trials and beyond
- Provide regulatory guidance to investigators and study teams on requirements, timelines, and compliance
- Lead regulatory document management ensuring accuracy, completeness, and audit readiness
- Coordinate responses to FDA information requests and regulatory submissions
- Participate in FDA meetings including pre-IND and Type B/C meetings
- In collaboration with the faculty, the Clinical In Vivo Gene Therapy group, and the Orphan Disease Center serve as a resource for developing IND/IDE studies, substantial amendments to their ongoing IND/IDE studies, or development or revision of industry-sponsored protocols
- Fully accountable for the timely development and submission of regulatory documents (e.g., pre-IND and end-of-phase briefing books, INDs, NDA/BLAs, CTAs, MAAs, responses to regulatory queries, IND safety reports, etc.)
- Lead cross-functional teams in preparation for regulatory agency meetings
- Ensure compliance with FDA regulations; establish quality policies, practices, procedures, and standards by which operations are performed; develop and maintain a quality management system for GxP activities; and implement process improvements to enhance regulatory effectiveness and compliance
- In collaboration with faculty and Clinical In Vivo Gene Therapy group members, interact with relevant academic and industry collaborators and serve as key point of contact on behalf of CHOP
- Recruit and mentor regulatory and research team
- Anticipate changes in regulatory policy and incorporate evolving requirements into development strategies
- Align regulatory activities with clinical, scientific, manufacturing, and quality stakeholders
- Assist staff involved in genome editing work with development and implementation of relevant investigator and coordinator education and training modalities to improve the overall quality of clinical trials research at CHOP
- Serve as a resource to investigators to develop Data Safety Monitoring Plans and assure that the studies proposed at CHOP comply with applicable federal, state and international guidelines or regulations governing the conduct of clinical trials research
- Work closely with academic and/or industry manufacturing colleagues on CMC regulatory package strategy and preparation
Education Qualifications
- Bachelor's Degree - Required
- Master's Degree - Preferred
Experience Qualifications
- At least twelve (12) years of gene therapy clinical research experience - Required
- At least twelve (12) years of related regulatory experience including gene therapy INDs, BLA preparation and FDA, IRB & other regulatory authority collaboration - Required
- At least twelve (12) years of gene therapy grant writing experience - Required
- At least twelve (12) years of intellectual property development experience - Required
Skills and Abilities
- Advanced proficiency with establishing novel treatment U.S. and E.U. regulatory and clinical strategy and implementation, including from preclinical to registration phases across multiple therapeutic areas
- Advanced proficiency with clinical research management, trial conduct, and clinical trial oversight
- Advanced knowledge of FDA and other regulatory agency gene therapy guidelines, including IND/IDE requirements, DSMP and DSMB charter development
- Advanced knowledge of federal, state, and local regulations for human research subject protections including ICH/GLP/GCP/GMP guidelines
- Advanced knowledge of gene therapy regulatory pathways, designations and pharmaceuticals including FDA Orphan Designation, breakthrough therapy and novel potential regulatory pathways
- Advanced knowledge of product manufacturing including related quality assurance & quality control systems
- Ability to effectively manage competing priorities
To carry out its mission, CHOP is committed to supporting the health of our patients, families, workforce, and global community. As a condition of employment, CHOP employees who work in patient care buildings or who have patient facing responsibilities must receive an annual influenza vaccine. Learn more.
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SALARY RANGE:
$100,000.00 - $375,000.00 Annually
Salary ranges are shown for full-time jobs. If you're working part-time, your pay will be adjusted accordingly.
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This job is eligible for an incentive program.
At CHOP, we are committed to fair and transparent pay practices. Factors such as skills and experience could result in an offer above the salary range noted in this job posting. Click here for more information regarding CHOP's Compensation and Benefits.
