Director Regulatory Affairs

At Houston Methodist The Director Regulatory Affairs position is responsible for providing regulatory guidance regarding pre-clinical and clinical research as well as product development support in compliance with applicable regulations and standards for Houston Methodist Research Institute (HMRI). This position assists research teams with understanding and development of clinical investigational plans, expectations for data needed to support product development programs or regulatory reporting or application. The Director position responsibilities include overseeing the activities of the department staff, ensuring quality, productivity, functional excellence and efficiency to accomplish strategic and operational objectives. In addition, this position is accountable for employee engagement, adequate staffing levels, budget development and compliance, staffing decisions such as hiring and terminating employment, coaching and counseling employees on work-related performance, and developing and implementing policies and procedures to ensure a safe and effective work environment. This position also ensures training, monitoring and operations initiatives are implemented which secure compliance with ethical and legal business practices and accreditation/regulatory/government regulations. FLSA STATUS Exempt

QUALIFICATIONS EDUCATION

Advanced degree (MS, PharmD, MD) in scientific or related field

EXPERIENCE

Eight years of Regulatory Affairs experience within an FDA regulated industry, preferably devices, diagnostics, or pharmaceuticals and/or within an academic medical center setting that routinely requires investigational or marketing submissions to FDA or similar Health Authorities Experience in reviewing and successful submission of applications to Health Authority including Investigational Drug, Device (IND/IDE) compassionate use, pre-submission requests, market applications Prior experience representing Regulatory Affairs on cross-functional teams is desirable; Must be capable of effectively leading teams in preparation of submissions. Previous managerial or leadership or lead positions

LICENSES AND CERTIFICATIONS

Required RAC-DRUG - Regulatory Affairs Certifications Pharmaceuticals (RAPS) - Regulatory Affairs Professionals Society_PSV Preferred RAC-DEVICE - Regulatory Affairs Certifications Medical Devices (RAPS)

KNOWLEDGE AND ABILITIES

Demonstrates the skills and competencies necessary to safely perform the assigned job, determined through ongoing skills, competency assessments, and performance evaluations Sufficient proficiency in speaking, reading, and writing the English language necessary to perform the essential functions of this job, especially about activities impacting patient or employee safety or security Demonstrates the ability to interact with others in a way that gives them confidence in one’s intentions and those of the organization Ability to use appropriate interpersonal styles and techniques to gain acceptance of ideas or plans; modifying one’s own behavior to accommodate tasks, situations and individuals involved Demonstrates leadership qualities and critical thinking through self-direction initiative and effective interpersonal skills and oral/written communication skills Ability to identify and understand issues, problems and opportunities, comparing data from different sources to draw conclusions; using effective approaches for choosing a course of action or developing appropriate solutions; taking action that is consistent with available facts, constraints and probable consequences Extensive knowledge of regulatory and accreditation agency requirements that impact department; stays abreast of industry changes Demonstrates highly effective communication skills—strong written communications and platform presentation abilities Ability to work effectively in a fast-paced environment Demonstrates flexibility and adaptability in the workplace Capable of leading teams/facilitating groups, building consensus and garnering highest confidence in professionalism and work product by senior leadership Ability to work under pressure and balance many competing priorities; highly responsive and solution/action oriented Proficiency in spreadsheet, word processing, and presentation software Maintains a positive and supportive attitude and demeanor Professional handling of exposure to confidential/sensitive information Prior experience with successful submission of regulatory applications for investigations, Investigational New Drug/Investigational Device Exemption Demonstrated expertise in IND/IDE processes, GMP production, GLP, GCP investigations including Phase I/II and early phase trial design ESSENTIAL FUNCTIONS PEOPLE ESSENTIAL FUNCTIONS Directs, develops and implements strategic and operational/high level projects and processes either through independent/highly autonomous work or through the facilitation of work teams to enable the effective and efficient completion of objectives. Oversees management of and ensures development for staff to meet overall objectives in terms of quality, service and cost effectiveness. Provides timely guidance and feedback to help others strengthen specific knowledge/skill areas needed to accomplish a task or solve a problem. Directs management responsibilities of selection, scheduling, supervision, retention, and evaluation of employees. Meets or exceeds threshold goal for department turnover and/or system metrics on employee engagement indicators. Provides leadership and communication to maintain a competent and engaged employee group by conducting regular department meetings to review policies and procedures and operational matters, rounding on all employees, completing performance appraisals, conducting new hire feedback sessions, coaching/corrective counseling, and providing recognition/commendations to achieve desired outcomes. Identifies opportunities and takes action to build strategic relationships between one’s area and other areas, teams, departments, and units to achieve business goals. Drives the promotion of teamwork within and between departments; participates and/or leads and facilitates department process improvements as needed. Reviews, manages, coordinates resources as appropriate for workloads of direct reports as needed and cross-functional team members to maximize project performance. Serves as liaison, interfacing with key stakeholders, committees, and team leaders to bring translational research projects into operation. SERVICE ESSENTIAL FUNCTIONS Oversees the regulatory affairs department operations, designated projects, schedules and activities as needed to ensure that goals or objectives are accomplished within the prescribed time frame. Sets priorities and functional standards, giving direction to staff as necessary to ensure the best possible delivery of service and high customer/patient satisfaction. Drives department service standards and activities to impact department and/or system score for patient/customer-based satisfaction through role modeling and fostering accountability. Serves and actively participates on various entity committees as a voice for the department. Provides comprehensive management oversight and regulatory guidance to move projects forward from basic laboratory research to regulated environments: Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), First in Human (FIH), early phase clinical trials. Provides strategy, regulatory review for submissions including Investigational New Drug (IND), Investigational Device Exception (IDE), New Drug Application (NDA), Biologics License Application (BLA), Premarket Approval (PMA), 510 (k). Provides assistance and guidance in all aspects of moving projects from the lab to a regulated environment, including advisement on SOP development, project feasibility, experimental design, completion of appropriate documentation for required reporting. QUALITY/SAFETY ESSENTIAL FUNCTIONS Ensures a safe and effective working environment; monitors and/or revises the department safety plan and/or any specific accreditation/regulatory required safety guidelines. Responsible for staff maintenance of credentials and competencies, per accrediting/ licensing agency and/or department guidelines as applicable. Employs a proactive approach in the optimization of safe outcomes and information systems by monitoring and improving the department workflow and enhancing operations, using peer-to-peer accountability and identifying solutions via collaboration. Implements process improvements utilizing tools such as lean principles. Role models situational awareness, using teachable moments to improve safety. Responsible for employee compliance to policies and procedures and performs associated actions upon non-compliance (i.e., licensure/certification compliance, focal point review requirements, disaster plan, in-services, influenza immunization, wage and hour, standard hours, timely termination submission, timely timecard approval, etc.). Assists, advises, consults and makes recommendations to basic research teams on project/investigation plans, areas of risk and potential risk mitigation plans, with understanding and development of translational investigation plans, expectations for data needed to support product development programs, regulatory reporting or applications. FINANCE ESSENTIAL FUNCTIONS Develops and manages department operational and capital budgets, approvals, and ongoing maintenance of the department(s), ensuring operation in a cost-effective manner. Proactively identifies and plans for capital needs related to current equipment and future department projects. Ensures staffing plans and schedules meet department needs that reflect understanding of the importance of cost-effectiveness. Creates department strategies to achieve financial target and staffing needs, through optimizing productivity, supply/resource efficiency, minimizing incidental overtime and overtime percentage, and other areas according to department specifications. Directs post-award management, resource allocation, oversight and conduct of Translational Research Initiative (TRI) and other assigned large-scale strategic institution projects. Reviews project plans, investigation designs and proposals with draft budgets to determine suitability. Obtains internal and external vendor or referred service proposals or contracts as necessary to carry out project plans. GROWTH/INNOVATION ESSENTIAL FUNCTIONS Identifies and implements innovative solutions for practice or workflow changes to improve department, entity or system operations by leading unit projects and/or other department/ system-directed activities. Proactively leads task forces and committees. May represent HM at assigned community or professional organization meetings. Drives change initiatives, maintaining effectiveness when experiencing major changes in work responsibilities or environment; adjusts effectively to work within new work structures, processes, requirements or cultures. Partners effectively with stakeholders as appropriate. Ensures own career discussions occur with appropriate management. Completes and updates the My Development plan on an ongoing basis. Conducts conversations with staff on their development. Monitors progress of technology through research investigations for readiness to proceed with next stage of development or licensing opportunity.

SUPPLEMENTAL REQUIREMENTS

WORK ATTIRE Uniform: No Scrubs: No Business professional: Yes Other (department approved): No

ON-CALL*

*Note that employees may be required to be on-call during emergencies (ie. Disaster, Severe Weather Events, etc) regardless of selection below. On Call* Yes TRAVEL Travel specifications may vary by department May require travel within the Houston Metropolitan area Yes May require travel outside Houston Metropolitan area Yes

QUALIFICATIONS EDUCATION

Advanced degree (MS, PharmD, MD) in scientific or related field

EXPERIENCE

Eight years of Regulatory Affairs experience within an FDA regulated industry, preferably devices, diagnostics, or pharmaceuticals and/or within an academic medical center setting that routinely requires investigational or marketing submissions to FDA or similar Health Authorities Experience in reviewing and successful submission of applications to Health Authority including Investigational Drug, Device (IND/IDE) compassionate use, pre-submission requests, market applications Prior experience representing Regulatory Affairs on cross-functional teams is desirable; Must be capable of effectively leading teams in preparation of submissions. Previous managerial or leadership or lead positions

LICENSES AND CERTIFICATIONS

Required RAC-DRUG - Regulatory Affairs Certifications Pharmaceuticals (RAPS) - Regulatory Affairs Professionals Society_PSV Preferred RAC-DEVICE - Regulatory Affairs Certifications Medical Devices (RAPS) #J-18808-Ljbffr Houston Methodist