À propos de ce poste Associate Medical Director chez Iovance Biotherapeutics
Iovance Biotherapeutics 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 human immune system to recognize and attack diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer.
Overview
The Associate Medical Director is primarily responsible for physician-supported clinical trial support and overseeing the direction, planning, execution, and interpretation of IOVANCE clinical trials.
Essential Functions and Responsibilities
- Primary point of clinical contact for IOVANCE clinical trials. Directs protocol implementation including site identification and communication with Clinical Operations, attendance at investigators’ meetings (virtual and live), correspondence with sites regarding patient eligibility and safety considerations, and interaction with US- and Global Medical Affairs teams
- Co-manages program development and reports directly to Executive Medical Director. Responsible for cross-functional collaboration with all of the disciplines necessary for successful drug/therapy development (Study Management Team level): clinical, manufacturing, quality assurance, regulatory, medical affairs, legal, biostatistics, global patient safety, data management, pharmacovigilance, and clinical operations
- Monitors clinical trials including the oversight of all aspects of trial conduct and safety, contact with investigators and site study staff, and CRO medical monitors
- Supports data analysis and assembly, including IDMC meetings, interim analyses, IB authoring, and clinical study report writing
- Contributes to the preparation of abstracts, presentations, and manuscripts in partnership with Publications Team
- Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
- Perform miscellaneous duties as assigned.
Travel
- Travel time is approximately 10-15% including visits to investigative sites and attendance at major oncology meetings
Required Education, Skills, and Knowledge
- Board Certified MD (Hematology/Oncology highly desired) with minimum of 1-2 years of oncology clinical trials experience (may be within industry or academia)
- Effective oral and written communication skills and excellent interpersonal skills with demonstrated ability to work with a team
- Demonstrated independence, initiative and the ability to work well in a fast-paced environment
Preferred Education, Skills, and Knowledge
- Subspecialty training in oncology and/or hematopoietic transplantation preferred
- Outstanding academic achievement and significant clinical trial experience preferred
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.
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 or remote office environment and requires operating standard office equipment and keyboards.
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The annual base salary we reasonably expect to pay is listed. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of the role, job duties/requirements, and relevant education, experience and skills.
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 [email protected].
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