Senior Medical Director

The Medical Director , oversees the direction, planning, execution, and interpretation of clinical trials and the data collection activities.

Essential Duties/ 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 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 and comprehending biomarker exploration

• 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 IND submissions, investigator brochure authorship and communication with US and international regulatory agencies

Requirements

• 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

• Travel time is approximately 5-10% (as needed) including visits to investigative sites, regulatory agencies

Education/ Training

• MD or MD/PhD

• Minimum three years of industry experience

• Subspecialty training in oncology and/or hematology preferred

• Outstanding academic achievement and significant clinical trial experience preferred