Successful completion of MD training mandatory; completion of training in a medical sub-specialty with a completed fellowship in a Hematology-Oncology program preferred.
Hematology or Oncology Board eligibility or certification preferred.
Clinical practice experience of a minimum of 3-5 years preferred.
7-10 years combined experience in academic and/or industry oncology clinical research an drug development, including experience as medical monitor or investigator on a clinical oncology trial.
At least 2 years in drug development industry in oncology and with previous exposure to clinical development, regulatory and statistical activities such as, e.g., (co-)authoring and reviewing of documents such as clinical trial protocols, statistical analysis plans, IND AR, NDA AR, PSUR, DSUR, IB, ICF, orphan drug designations, regulatory briefing document, etc. is preferable.
Other Skills and Abilities:
Working knowledge of the drug development process in the USA and EU is required.
Experience in direct interactions with US and/or EU Regulatory authorities is highly preferred.
Highly detail and quality oriented.
Excellent presentation skills.
Ability to learn, integrate complex information, and communicate clinical information in easily understandable fashion to non-clinical team members.
Ability to understand and implement prioritization of deliverables as well as recognize and highlight conflicts in priorities.
A positive attitude, flexibility and a proactive thought process.
Ability to read, analyze and interpret scientific and technical information and data.
Excellent English communication skills, both verbal and written.
Ability to define problems, collect data, establish facts, and draw valid conclusions.
Ability to interpret an extensive variety of technical information and deal with several abstract and concrete variables.
While performing the duties of this job, the employee is frequently required to sit, talk and hear.
The employee is occasionally required to walk.
Must be able to travel domestically and internationally on a reasonably frequent basis (approx. 15-20% of time including some weekend travel).
The noise level in the work environment is usually quiet. The noise level in the office work environment is usually quiet.
Domestic and international travel includes spending time at cancer trial sites/institutions, conference centers, offices and hotels.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The incumbent in this position may be required to perform other duties, as assigned.