Are you a CMO looking for an early stage, rising star biopharma company where you can lead strategically and operationally? Our client is advancing to clinic with a lead small molecule compound and full, preclinical pipeline. Having just closed another a round of funding, they are well positioned for clinical trials. The science and technology of this company is innovative, timely, and applicable to a wide range of diseases. Young, but well-financed and rapidly growing, the company is ready to hire their CMO to position themselves for future success. Initially targeting oncology therapeutics, additional indications are likely. This leadership position will provide direction, strategy, and execution of the company’s clinical development.
- An MD with Board Certification
- Extensive management experience leading a clinical group including clinical & medical affairs
- Knowledge and experience with science-driven and data-driven drug development
- Understanding of FDA/ICH regulations and guidelines
- Must have previously interacted with FDA personnel
- Proven record of success in clinical trial design and IND submission
- Preferred: hematology, oncology, and/or immune-oncology training
- Pre-clinical and clinical development coordination of multiple therapeutic degrader programs
- Provide direction and plans for development of clinical strategies to advance therapeutic compounds into clinical trials (oncology, pain, and etc.).
- Prepare clinical documents and manage regulatory strategies
- Manage interactions with the FDA
- Oversee the analysis of clinical trial data
- Interpret the clinical trial data and report clinical trial results
- Recruit, lead, and mentor clinical management team
To apply for this position, confidentially email us here.