Sr. Medical Director, Clinical Development
San Carlos, CA, United States
Sr. Medical Director, Clinical Development
Remote Based
Oncology-Hematology | Cell Therapy
Pay Range: $325,000 - $350,000
Overview:
Meet are exclusively partnering with a mid-sized biotech who have developed a T-cell based immunotherapy platform targeting both solid and liquid tumors. Off the back of their first FDA approval they are anticipating significant growth of 30% across multiple business sectors in H2 of this year.
Reporting to the SVP, Clinical Development we are seeking a Sr. Medical Director who will be responsible for overseeing the direction, planning, execution, and interpretation of assigned clinical trials/programs and data collection.
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 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 the Regulatory group and regulatory agencies, taking part in regulatory submissions, investigator brochure authorship and communication with US and international regulatory agencies
Education and Background: Board Certified MD with minimum 5 years of industry experience
Subspecialty training in oncology and/or specific industry experience in oncology preferred
Academic achievement and significant clinical trial experience preferred
To learn more about the position please contact [email protected] , or contact 628-229-9023