Director, Clinical (Oncology/M.D.)

Responsibilities

Develop, advocate for, and implement clinical development plans, protocols, and strategies for oncology indications. Develop and maintain relationships with academic investigators, pharmaceutical sponsors/partners, and key opinion leaders. Identify clinical investigators and coordinate their activities in clinical trials and advisory board meetings. Represent the company to external audiences in the medical, financial, and pharmaceutical industry communities. Work with clinical research associates, clinical pharmacologists, medical writers, statisticians, data management, members of multidisciplinary project teams and their managers to review and interpret data. Provide guidance for clinical data organization and analyze clinical data to support advancement of drug candidate product for all phases. Oversee timely reporting of safety signals to regulatory authorities and the generation of clinical study reports. Prepare clinical portions of INDs and New Drug Applications ( NDAs ), investigator brochures, medical reports, and safety summaries. Prepare manuscripts for technical journals and make presentations at scientific meetings.



Qualifications

A M.D. or M.D. /Ph.D. degree in a relevant scientific discipline with a minimum 3 -5 years' experience in Oncology clinical research, preferably in the biotech/pharmaceutical industry. Board certification in Oncology strongly preferred. Experience designing and conducting clinical trials. Strong management and organizational skills.