Overview
The Medical Director is primarily responsible for overseeing the direction, planning, execution, and interpretation of clinical trials and the data collection.
Essential Functions and Responsibilities
- Directs protocol implementation including site identification and communication, attendance at investigators’ meetings, correspondence with sites including IRBs and interaction with operations teams.
- Manages program development, including working cross-functionally with all of the disciplines necessary for successful drug/therapy development: pre-clinical, manufacturing, quality assurance, regulatory, medical affairs, legal, biostatistics and data management, pharmacovigilance, and clinical operations.
- Interacts closely with the pre-clinical team, to understand the scientific basis of targeted therapy, and to apply this knowledge to articulating therapeutic strategies.
- Monitors clinical trials including the oversight of all aspects of trial conduct and safety, contact with investigators and site study staff.
- Supports data analysis and assembly, including clinical study report writing, contributes to the preparation of abstracts, presentations, and manuscripts.
- Interacts closely with Medical Affairs in support of ISTs and publications.
- Interacts closely with the Regulatory group and regulatory agencies, taking part in regulatory submissions, investigator brochure authorship and communication with US and international regulatory agencies.
- Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
- Perform miscellaneous duties as assigned.
Travel
- Travel time is approximately 15% to 25% including visits to investigative sites, regulatory agencies, non-local company sites, and attendance at major oncology meetings.
Required Education, Skills, and Knowledge
- Board Certified MD with minimum of 3-5 years of industry experience.
- Prior experience in cell therapy is required.
- 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.
- Subspecialty training in hematology-oncology is required.
- Outstanding academic achievement and significant clinical trial experience are required.
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
- 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 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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