Director, Clinical Operations Compliance, Standards and Training

Overview

The Director of Clinical Operations Compliance, Standards and Training is a new role in a fast-growing organization with locations in San Carlos (CA), Philadelphia (PA), Tampa (FL) and Europe (The UK and The Netherlands). This Director, located in the US, preferably in the San Francisco Bay Area, will provide GCP/ICH Clinical Operations leadership, strategic development, and tactical implementation of operational quality initiatives, supporting a quality culture in the execution of Iovance's clinical trials.

The successful candidate will provide guidance and support for Clinical Operations including implementation and oversight of clinical operations quality initiatives and ensuring that our clinical trials are conducted in compliance with SOPs, ICH/GCP/regulatory guidelines and company goals.

Essential Functions and Responsibilities

An entrepreneurial start-up mentality and an ability to work collaboratively:

• This person will provide strategic input and collaborate with study teams to maintain GCP compliance for the operational execution of Iovance's clinical operations programs.
• Be the Clinical Operations SME for GCP, non-compliance surveillance, Quality Events, process optimization, and audit/inspection readiness and responses
• Remain current on new and changing regulations globally and ensure that processes, SOPs and plans reflect current regulations and guidelines
• Lead Clinical Operations study teams in inspection readiness activities, and mock and real inspections
• Track quality issues, deviations, and corrective actions ensuring effectiveness and delivery
• Partner with Clinical Operations personnel in root cause analyses and advise on content of CAPAs/deviations/Clinical Quality Events/Serious Breaches and audit and inspection responses
• Drive the design, development, and implementation of SOPs, study document templates, change controls and training programs to support process quality, GCP compliance and inspection readiness
• Evaluate department needs to design, develop and implement annual training plans for Clinical Operations
• Partner with Clinical Quality Assurance and other clinical development departments to manage study specific training and ensure adherence to GCP compliance execution
• Partner with Clinical Quality Assurance on remediation of quality issues related to clinical study conduct. Act as a liaison with CQA to ensure coordination and communication of quality driven initiatives to ensure alignment of compliance decisions and recommended actions implementation
• Participate in development of KPIs aligned with clinical operations study teams and leadership goals focused on performance drivers and key issues, risks and business drivers
• Perform ad hoc analytics as required
• Create and sustain a culture of compliance accountability and decision making built on solid regulatory understanding and analysis
• Must adhere to Iovance Biotherapeutics' core values, policies, procedures, and business ethics.
• Perform miscellaneous duties as assigned.

Travel

• Minimal but occasional domestic and international travel required, must be able to attend meetings and mock and real inspections in any office location as necessary

Required and Preferred Education, Skills, and Knowledge

• Bachelor's degree or higher degree in a scientific or adjacent field
• ICH/GCP expert with a strong understanding of FDA and EMEA regulations related to Clinical Operations and experience with development and implementation of procedural standards
• Prefer prior regulatory agency inspection experience
• Strong electronic systems compliance knowledge specifically around computer system validation and ALCOA+
• 10+ years of progressively complex roles in a clinical operations and/or clinical quality assurance function, people management experience is a plus
• Strong communication and relationship building skills, with the ability to interpret and summarize data to aid teams and management in achieving operational goals.
• Excellent analytical, decision-making, project management, and problem solving skills.
• Ability to manage multiple priorities simultaneously, comfortable with ambiguity, work well under pressure and adapt quickly to change.
• Willingness and curiosity to take deep dives into the status quo and drive effective changes that scale, even or especially if it means establishing new processes or what hasn't been done before.
• Ability to partner cross-functionally, through strong relationship building, influencing, negotiating and communication skills, with all levels of management.

Physical Demands and Activities Required

• Must be able to remain in a stationary position standing or sitting for prolonged periods of time.
• Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects.
• Must have visual acuity to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading.
• This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers.
• Must be able to communicate with others to exchange information.

Mental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines

Work Environment

This job operates in a professional workplace or remote office environment and requires standard office equipment and keyboards. Employees who work remotely are expected to maintain their workspace and environment safely and free from safety hazards.

The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time.

Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual's race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law. If you need assistance or accommodation to apply to one of our opportunities, please contact careers@iovance.com.

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