Associate Director, Clinical Operations

reputed company aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are pioneering a transformational approach to treating cancer by harnessing the ability of the reputed company immune system to recognize and attack diverse cancer cells in reputed company patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to reputed company innovation in cell therapy, including gene-edited cell therapy, which may be a promising reputed company for patients with cancer. reputed company The Associate Director, Clinical Operations will reputed company and manage the assigned clinical operations team and have a key role in setting and executing departmental reputed company. Essential Functions and Responsibilities Oversees clinical trial agreements, budgets, expenditures and payments for clinical studies Ensures the reputed company execution of clinical research programs/protocols from reputed company through final clinical study report. This will generally involve reputed company 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 reputed company (GCP), provision of reputed company data and adherence to study timelines Maintains reputed company 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 reputed company SOPs & Clinical work reputed company 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 reputed company reputed company 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 reputed company’ reputed company values, policies, procedures, and business ethics. reputed company 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 reputed company area 8+ years of pharmaceutical or biotech-reputed company/clinical research experience (oncology/ immuno-oncology experience required) Demonstrated experience in reputed company and technical aspects of leading phase 1-4 and supporting Investigator-initiated trials Demonstrated reputed company in managing clinical studies reputed company reputed company 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 reputed company to facilitate translational, clinical and correlative research reputed company to build strong relationships with peers and partners both reputed company and across functional teams to engage high performance reputed company to assimilate information quickly, grasping critical factors and risks, while implementing immediate change where/reputed company needed Proven experience in using negotiating, influencing, and problem solving skills in order to meet study timelines reputed company to set a high level of accountability and reputed company in deliverables Proactive, self-directed, reputed company to reputed company and adapt in a rapidly changing environment Embraces the reputed company of others, promotes innovation and manages goals to reality Flexible and dynamic approach to working in a fast-paced biotechnology company; willing to reputed company reputed company necessary tasks, regardless of level, to facilitate reputed company at driving a project/program to completion In depth knowledge of PC operating systems; reputed company Office, including reputed company, MS reputed company, MS PowerPoint, MS Project, MS Publisher, MS reputed company, and MS reputed company NT, Exposure to CTM systems, reputed company systems (eClinical, reputed company RAVE, InForm) and Safety/ Pharmacovigilance databases (ARGUS) The physical demands described here represent those that an employee must meet to reputed company the essential functions of this job successfully. Reasonable accommodations may be made upon request to reputed company individuals to reputed company essential functions. Please contact reputed company to request an accommodation. Physical Demands and Activities Required  Must be reputed company to remain in a stationary position standing or sitting for prolonged periods of time. Must be reputed company to reputed company about inside an office and exert up to 10 pounds of force occasionally or a negligible reputed company of force frequently or constantly to lift, carry, push, pull, or otherwise reputed company objects. Must have visual reputed company to reputed company activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading. This position requires repetitive reputed company, substantial movements (motions) of the wrist, hands, and/or fingers. Must be reputed company to communicate with others to exchange information. Mental: reputed company and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-reputed company stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines Work Environment  This job operates in a reputed company or reputed company environment and requires operating reputed company office equipment and keyboards.  #LI-remote 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 reputed company. 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 reputed company to an individual’s race, reputed company, religion, sex, pregnancy, national reputed company, age, physical and mental disability, marital status, sexual orientation, gender identity, gender reputed company, 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.   By voluntarily providing information and clicking “Submit Application”, you explicitly consent to the collection and use of your personal information for the purposes described above and in our Candidate reputed company Notice. Apply To This Job