Executive Medical Director

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July 4

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ResearchEd

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Education • Non-profit • Social Impact

ResearchEd is an education policy research nonprofit providing objective analysis, deep insights, and detailed recommendations for education institutions and research organizations seeking to support equitable student outcomes and promote community and economic development through education. ResearchEd conducts student-centered work, particularly focusing on underserved groups, and provides research, data capacity building support, and advocacy. Their mission is to empower action in education, aiming for equitable access to education as a catalyst for community success and social justice.

11 - 50 employees

Founded 2020

📚 Education

🤝 Non-profit

🌍 Social Impact

📋 Description

• 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. • 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. • 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.

🎯 Requirements

• Education : Doctor of Medicine or equivalent • Experience : Two years of oncology medical practice or 5 years of oncology clinical research experience in a medical role . • Required Certifications : Board eligible; prefer board certified; medical licensure strongly preferred • Required Skills : (Choose relevant skills & add position specific skills as needed.) Strong knowledge of the drug development process and FDA regulations, ICH GCP guidelines, and their application to clinical trials. Knowledge and experience with global regulatory reporting requirements for safety updates, Adverse Event reporting and other requires Medical and Safety submissions .