EXEC DIRECTOR, REGULATORY AFFAIRS & COMPLIANCE

Duties: The Gene Therapy Program (GTP) is a complex R&D organization consisting of research laboratories supported by multiple core functions which provide internal capacity to perform gene transfer studies from basic research through phase 1 proof-of-concept human trials. We currently employ ~150 FTEs with an annual operating budget of $55M based on a wide array of funding sources. The R&D organization has at its core a translational infrastructure that includes: technology discovery, specialized immunology assays operating under GLP, a Vector Core and Manufacturing unit that conducts GMP comparable work, and oversees CMOs in vector production, and a large nonclincal program for animal testing under GLP including large nonhuman primate and mouse vivaria.

Reporting to Director of the GTP and Orphan Disease Center (ODC), the Executive Director of Regulatory Affairs and Compliance (EDRAC) establishes and directs regulatory and compliance strategies for the development of novel therapeutics in humans that emerge from the R&D work of the Gene Therapy Program (GTP). The EDRAC will direct and oversee two areas of the Gene Therapy Program. On the Regulatory affairs side, the EDRAC will work with either our Sponsors and/or internal Penn personnel to execute RA strategies in the United States, Europe, Japan and other countries. The Gene Therapy Program collaborates with various Departments at Penn in the organization and conduct of phase I trials. These programs are conducted with multiple federal, nonprofit and commercial partners. The Executive Director of Regulatory Affairs and Compliance will work with applicable stakeholders to establish a regulatory strategy primarily focusing on preclinical and lead-in work to phase I/II clinical trials although s/he will participate and provide input to discussions regarding full clinical development plans. In virtually all programs, GTP will conduct the work from basic research to IND including: establishing enabling technology, creating the clinical candidate, proof-of-concept studies in animals, IND-enabling non-clinical studies, and manufacturing of vector for pre-clinical and clinical studies along with associated process development and analytical evaluations. The EDRAC will also work with the applicable regulatory sponsor on clinical issues. This will include the Office of Clinical Research when Penn is the regulatory sponsor and representatives/designees of external regulatory sponsors. S/he will work collaboratively with the Project Teams to execute programs, coordinate and help draft elements of all regulatory submissions, and partner with the functional teams to ensure compliance.

Additionally, the EDRAC will establish direction and oversee the Quality Assurance Unit (QAU) within the GTP. The QAU works with scientists and labs personnel to ensure overall compliance and Good Laboratory Practice (GLP) adherence supporting the development, manufacture, and nonclinical testing of viral vectors to enable early phase clinical trials. The QAU provides support for a GLP non-human primate (NHP) facility and GLP studies performed in a partial-GLP rodent facility, in addition to overall QAU support for GLP studies performed in the GTP labs (eg, analyses for IND-enabling studies). The EDRAC will ensure Quality Assurance support to the research-based portion of the GTP, in terms of SOP management, training, document management and archiving, and audit support. The position will interact with the senior management staff and directors of the other functional groups within GTP (Process Development, Facilities, Quality Control, and Operations) and will be responsible for ensuring GMP and GLP compliance across identified groups within the GTP. The EDRAC will ensure Quality Assurance oversight and auditing of all GTP groups working in the GLP environment as well as external audits of CROs working on behalf of GTP and their Sponsors.

Qualifications: *Master's degree and at least 7 years working in a regulatory capacity in the biotechnology or pharmaceutical industry or an equivalent combination of education and experience required.
* Preferred candidates will have experience working as a lead in Regulatory Affairs for regulatory strategy for IND submissions
* Preferred candidates will have experience with biologics submissions.
* Ability to interact effectively with external business partners and regulatory agencies
* Demonstrated excellence in leadership, with ability to motivate and lead people in a complex, changing environment
* Very strong strategic skills in creativity and effectiveness in identifying and addressing major strategic challenges,
* Ability to drive results within a cross-functional team/partnership environment, in a highly professional way.
* Excellent verbal and writing skills, with ability to analyze, define, and effectively convey difficult and complex issues in a way that accurately and persuasively communicates the issues to internal and external stakeholders
* Skilled in conflict resolution; fostering open communication, with attention to listening and facilitating discussion
* Strong negotiating skills with a creative solution-oriented focus.
* Ability to prioritize and handle multiple project priorities

Reference Number: 40-25420

Salary Grade: 031

Employment Type: Exempt

Org: DM-Gene Therapy Program

Special Requirements: Background check required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.

Job Family: B-Executive/Managerial Administration