This Clinical Stage Pharmaceutical company has an immediate need for an MD (ideally with specialty in Hematology or Oncology)
The SVP or EVP (DOE) will provide leadership to the organization, moving the progression of the company’s lead drug candidates through all phases of clinical development.
Design and execute clinical trials, running programs focused on targeted therapeutic indications, and collaborating with key internal stakeholders, external stakeholders including CROs and key opinion leaders.
- Leads the clinical development organization and executes efficient, high quality therapeutic programs based on the highest scientific, medical and regulatory standards
- Represents the company to outside medical/scientific experts; investigator selection; organizes investigators meetings and conducts other relevant activities to support development objectives.
- Responsible for developing and implementing the companies medical communications strategy
- Designs, implements and monitors clinical studies of novel hematology-oncology product candidates through clinical trials and successful product approvals
- Prepares the clinical portion of INDs, New Drug Applications (NDAs) and Biologic License Applications (BLAs), including protocols, investigator brochures, informed consent forms, case report forms, medical reports, safety and efficacy summaries, scientific rationales and benefit/risk ratios.
- Assures the Good Clinical Practices (GCPs) are followed; assures timely completion of studies; monitors safety and efficacy trends by reviewing clinical data; and writes clinical reports upon completion of studies.
- Ensures that appropriate objectives are met and that Company resources are effectively utilized to meet strategic product development plans by developing a timetable, budget and resource analysis for clinical programs and personnel administration.