The Director/ Senior Medical Director Oncology within the Clinical Development Department is responsible for providing the medical input and medical oversight for early or late stage Oncology clinical development programs. Strategic responsibilities include design and execution of clinical development plans for oncology products from preclinical research, First in Man studies through Phase I/II/III Clinical Trials.
The incumbent will successfully lead clinical trials Phase I - III, develop and author the necessary documents (e.g. NDA/CTA submissions, study protocols, Investigator Brochures, regulatory briefing books and regulatory response documents, clinical study reports, etc.) and provide expert clinical oncology input and review of the study data as well as lead publication of documents required. S(he) will provide medical oversight of all studies within their program as well as leadership of clinical study teams. S(he) will work closely with a clinical scientist to provide support for development of the program including preparation of briefing documents, supportive materials necessary to progress strategic development and discussion of the program internally and externally.
S(he) will be responsible for representing the company and its development program and the respective trials when engaging KOL’s or other leaders in the field.
A Medical Degree (MD or MD/PhD or DO) is required with a minimum of 2 years of industry experience. Board eligibility or certificationin Internal Medicine or Medical Oncology is preferred