Senior Medical Director

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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