Senior /Executive Medical Director, Oncology

Located – Whippany, NJ

 

The Medical Director will be the point of contact and responsibility for all medical aspects of a trial within the study team, in order to ensure patient safety, quality of medical data, and the best possible drug development within the framework of the trial. The Medical Director will support the global clinical project team with expert knowledge and insight into the study.

Provide medical support for the study team

• Global primary contact person during the course of the study for medical/safety questions

• Responsible for content of medical sections of protocol/amendments

• Facilitates center identification and medical discussions with investigators

• Participates in CRO selection to ensure that the CRO staff have the requisite subspecialty experience and defines outsourced medical activities

• Trains study team, monitors, site staff and CRO staff (if applicable) on medical aspects of the study, indication and compound

• Provides medical input at investigators’ meetings and presents the medical background and rationale for the trial

• Writes the medical review plan

• Reviews patient medical data (blinded) during the course of the study to identify possible safety or data quality issues (consults with international drug safety manager, clinical team and other relevant functions as needed).

• Reviews medical narratives and ensures that the narratives meet an acceptable medical standard in the Clinical Study Report (CSR)

• Gives input into the EDC checks and statistical tables/listings

• Supports the coding team for medical history, concomitant medications and adverse event Coding

• Reviews the statistical tables and interprets clinical data for the CSR

• Responsible for the content of the medical section of the CSR

Support the Global Clinical Development Project Team

• Brings expertise on the indication studied

• Brings in depth knowledge about the study and its patients

• Helps select the best countries to perform the trial

• Provides input into the project standards

• May support writing of study-related publication

Medical point of contact regarding the trial to outside bodies

• Defending the trial to regulators, IRBs,

• Preparing for DSMBs, steering committee and external consultants

• Able to answer and discuss in depth questions about the trial and its results

Point of reference for the Country Medical contact person

• Provides consistent replies across the countries / regions regarding the trial both to IRBs and health authorities

• Helps/ guides the country medical contact people in their study-specific local tasks

• Keeps updated medical FAQ lists for the study

Source of expert knowledge in the therapeutic area/ pathology

• Keeps up to date with scientific progress/ literature in the area

• Supports the participating countries in their needs of medical knowledge, e.g. through

• training/presentations to top KOLs etc.

• Participates in important local/regional/global advisory boards

• May help prepare/ negotiate Health Authority Approvals and reimbursement

Work interactions

Works closely with the Study Manager and study team, the Clinical Lead, the Principal Investigator/ Steering Committee of the trial and the global scientific community in the indication/TA.

Requirements   • M.D. degree is required; Board Certification in Oncology is preferred

• 0-5 years’ development experience in the pharmaceutical industry, Academia or Practice or combination

• Must be fluent in English, both written and spoken

• Familiar with the regulatory and legal environment

• Collaborative and a team player

• Sensitive to different global cultures/needs

• Good communication skills