Director, Clinical Operations

Overview

The Director, Clinical Operations will lead and manage the assigned clinical operations team and have a key role in setting and executing departmental strategy.

Essential Functions and Responsibilities

• Oversees clinical trial agreements, budgets, expenditures and payments for clinical studies.
• Ensures the timely execution of clinical research programs / protocols from conception through final clinical study report.

This will generally involve close supervision of external contract organizations who will have responsibility for site interaction, site monitoring, data management, biostatistics, IRB interaction, central laboratory function, clinical research budget negotiation, medical writing, pharmacovigilance, and other critical activities.

• Establishes and maintains good working relationships with clinical study site personnel to ensure adherence to protocols and Good Clinical Practice (GCP), provision of quality data and adherence to study timelines.
• Maintains oversight of the conduct of the studies at the study centers (site selection, start up, monitor adherence to protocols and Good Clinical Practices (GCP), applicable guidance and study closure)
• Key contributor to the preparation and management of clinical study protocols and protocol amendments
• Assists with preparation of key documents e.g. Investigator Brochures, FDA Briefing Documents, internal or external presentations, etc.
• Contributes to the review of Investigator Sponsored Trials (ISTs) & the relevant documentation to support these trials.
• Contributes to the creation of internal Iovance Biotherapeutics SOPs & Clinical work practice documents and implementation of these plans for Clinical Operations to operate in accordance with FDA & EMA regulations.
• Interfaces with Chief Medical Officer / Medical Monitor and cross-functional team members including Data Management, Drug Safety, Logistics / Manufacturing, Project Management, Regulatory Affairs, and Biostatistics
• Provide direct supervision of Clinical Operations team members, including performance management and development planning.
• Serve as company representative at external meetings, scientific congresses, etc.
• Must adhere to Iovance Biotherapeutics' core values, policies, procedures, and business ethics.
• Perform miscellaneous duties as assigned.

Travel

Available to travel up to 20% of the time.

Required Education, Skills, and Knowledge

• Bachelor's Degree in health, or science related area
• 12 to 16 years of pharmaceutical or biotech-related / clinical research experience (oncology / immuno-oncology experience required)
• Demonstrated experience in core and technical aspects of leading phase 1-4 and supporting Investigator-initiated trials.
• Demonstrated success in managing clinical studies within timeline and budget.
• Demonstrated managerial skills and strong interpersonal and communication (verbal and written) skills in interacting with clinical monitors, investigators, and various individuals in specialized areas or internal groups to facilitate translational, clinical, and correlative research.
• Able to build strong relationships with peers and partners both within and across functional teams to engage high performance.
• Able to assimilate information quickly, grasping critical factors and risks, while implementing immediate change where / when needed.
• Proven experience in using negotiating, influencing, and problem-solving skills in order to meet study timelines.
• Able to set a high level of accountability and quality in deliverables.
• Proactive, self-directed, able to thrive and adapt in a rapidly changing environment.
• Embraces the ideas of others, promotes innovation and manages goals to reality.
• Flexible and dynamic approach to working in a fast-paced biotechnology company; willing to perform all necessary tasks, regardless of level, to facilitate success at driving a project / program to completion.
• In depth knowledge of PC operating systems; Microsoft Office, including MS Word, MS Excel, MS PowerPoint, MS Project, MS Publisher, MS Outlook, and MS Windows NT,
• Exposure to CTM systems, EDC systems (eClinical, Medidata RAVE, InForm) and Safety / Pharmacovigilance databases (ARGUS)

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully.

Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.

Physical Demands and Activities Required (This would need to be adjusted by HRBP depending on the position and needs using the assessment form)

• 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 or remote office environment and requires operating standard office equipment and keyboards.

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 redacted .

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