Overview
The Senior 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, marketing, 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
Supports commercial teams, through the communication of medical issues to the commercial group, and by helping to formulate medical opportunities for the marketing team
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, and attendance at major oncology meetings
Required Education, Skills, and Knowledge
Board Certified MD with minimum 5 years of industry experience
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 or organ 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. Please contact Human Resources to request an accommodation.
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