ABOUT THE ROLE
As our new Medical Director of Oncology, you’ll already be a US based oncologist with CRO or Pharma experience from an oncology clinical trial background for phase 1 -3 medical monitoring activity.
You’ll be responsible for providing medical advisory support and leadership by overseeing medical issues in phase I – IV clinical trials with a primary focus on protecting the safety of study participants and ensuring that all medical issues are recorded and reported in accordance with the clinical trial protocol, standard operating procedures (SOPs), good clinical practice (GCP), and all other applicable regulatory requirements. *Please note, this role has the potential to be hired at the Senior Medical Director level depending upon individual experience.
Specific tasks would include:
- Provide management leadership to physicians and medical monitors for the Oncology Center of Development.
- Assists in the procurement, management, training, and work assignments of contractor and full-time medical monitor staff.
- Provide project physician support to clinical study teams during the execution of clinical research studies, including protocol development, eCRF development, therapeutic area training, protocol queries, patient eligibility determination, clinical/safety data review, and clinical summary report generation.
- Liaison with external clients, IRBs, DMCs, vendors, and regulatory agencies for study-related medical issues.
- Provide medical advisory input to business development activities including proposal development/budgeting, feasibility input, and sales presentations.
- Educates the study team on medical aspects of conducted or planned clinical trials.
- Participates in study start-up, investigator, client meetings, Federal Drug Administration (FDA) meetings, meetings with National authorities.
- Reviews and contributes to medical aspects of trial-related documents such as Medical Monitoring Plan, Study Protocol, and Investigator Brochure.
- Reviews medical aspects of protocol eligibility/compliance, waivers, deviations, dose-escalation determinations, CRFs, clinical study reports, and regulatory submissions.
- Reviews laboratory results and results of other examinations of study subjects.
- Collects monitors and analyzes information related to adverse events (AEs) and serious adverse events (SAEs). Reviews associated safety case narratives to assure claims of causality and expectedness are reasonable and medically sound.
- Reviews or assists in the review of medical coding to assure congruency with the terms reported in the case report form (CRF) and provides re -coding of the event if appropriate.
- Participates in masked or unmasked data review and Data Safety Monitoring Board activities.
- Medical Doctor or DO, board-certified US-based Oncologist is preferred
- Minimum of 5 years’ experience working as a medical advisor/medical monitor in oncology clinical trials.
- An active medical license is optimal, not mandatory.
- In-depth knowledge of medical terminology and of GCP, ICH guidelines relevant to global drug safety, and the drug development process and regulations.
- Proficiency in Microsoft Office; Word, Excel, PowerPoint, Outlook as required.
- Effective verbal and written communication skills in both English and local languages, if applicable.
- Ability to travel