Executive Medical Director

Catalyst Clinical Research provides customizable solutions to the biopharmaceutical and biotechnology industries through Catalyst Oncology, a full-service oncology CRO, and multi-therapeutic global functional and CRO services through Catalyst Flex. The company's customer-centric flexible service model, innovative technology, expert team members, and global presence advance clinical studies. Visit CatalystCR.com.  

As the Executive Medical Director you will take accountability for the following functions/activities:

• Protect subject safety in clinical trials and promote protocol compliance.
• Product Safety data review and evaluation
• Medical monitoring
• Medical strategy in support of proposals, bid defenses and new contract awards.

Position Responsibilities/Accountabilities:

Perform core medical monitoring activities for assigned studies, which may include:

• Input into study design, protocol and regulatory approval strategy.
• Response to inquiries from the sites, regulatory authorities, IRBs/IECs.
• Write or support the writing of study or safety monitoring plans.
• Perform the medical review of patient data during the study period and provide input for the clinical study report.
  Evaluation of patients’ eligibility, interpretation and appropriate management and reporting of patient safety data throughout the lifecycle of the study in accordance with ICH Good Clinical Practice, applicable regulatory guidelines and company standard operating procedures.
• Medical guidance to site personnel and the project team regarding Protocol and other study-specific medical aspects.
• Review adverse events (AEs), serious adverse events (SAEs) and AEs of Special Interest and participate in safety signal detection activities to identify emergent safety concerns and recommend appropriate action.
• Protocol deviations review with proposed grading from medical/safety perspective.
• 24/7 medical consultancy support to investigators and project team.
• Participation at Kick-off meetings, Investigator meetings and other study related meetings.
• Additional Medical Data Review, as agreed with the sponsor in the Scope of Work.
• Training of the project team and investigators on the indication, IMP, and medical aspects of the study.
• Support Business Development activities, including medical protocol considerations for proposals, help with feasibility assessments, marketing material development, review of proposals/contracts for medical services, and attendance at bid defense meetings.
• Act as medical advisor to sponsor companies when required.
• Function as medical representative in client meetings.
• The role also contributes to the development of Catalyst’s Site network.
• Provides oncology thought leadership and supports marketing efforts, meeting attendance, presentations.
• Support Regulatory consulting opportunities including client interactions and assigning appropriate consultants
• Prepare and review relevant board presentations and reports.
• Supporting our network of medical monitors including recruitment, hiring and training.
• Responsibility for medical monitoring budget updates on an ongoing basis per our change management process.

Managerial Requirements/ Responsibilities:

Position will have management responsibilities.  Development, oversight, and direction of departmental staff which may include interviewing, terminations, training, personal growth, retention plans, coaching/performance management, goal setting, & salary.

Position Qualification Requirements:

Education: Doctor of Medicine or equivalent