Sr. Medical Director, Clinical Development
144007 Posted : 07th May 2024
- 325000 USD - 350000 USD
- San Carlos, United States
- Permanent
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
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