Director, Medical Monitor (MD) Location: New York, United States Summary: An experienced physician specializing in clinical development, providing strategic medical oversight and monitoring for innovative immuno-oncology programs. Expertise in leading clinical trial design, execution, and safety monitoring for early- and late-stage programs in oncology. Strong background in regulatory interactions, cross-functional leadership, and clinical trial operations. Key Responsibilities: Serve as the primary medical contact for assigned clinical trials, ensuring protocol adherence and safety oversight. Address medical inquiries from investigators, regulatory agencies, and internal teams, ensuring consistent application of protocol guidelines. Monitor clinical trial conduct, assessing safety data, adverse events (AEs), serious adverse events (SAEs), and emerging safety signals. Provide medical expertise in study design, protocol development, and execution, collaborating with cross-functional teams to advance clinical programs. Support site selection, patient recruitment, and investigator engagement through regular interactions and guidance. Lead or co-lead clinical study teams, facilitating discussions and decision-making processes. Participate in interactions with regulatory authorities, preparing clinical documentation and supporting regulatory submissions. Collaborate with key opinion leaders (KOLs), clinical investigators, and external stakeholders to advance clinical development objectives. Develop and review essential study documents, including protocols, investigator brochures (IBs), informed consent forms (ICFs), data review plans, and clinical study reports (CSRs). Contribute to internal governance processes and strategic development discussions. Support publication planning and contribute to abstracts, posters, and manuscripts. Qualifications & Experience: Medical Degree (MD or equivalent) with a strong background in oncology and hematology. 10+ years of experience in pharmaceutical/biotech clinical development or relevant clinical research roles. At least 5 years of experience serving as a medical monitor for clinical trials. Extensive knowledge of clinical trial safety monitoring, adverse event assessment, and regulatory requirements. Familiarity with global regulatory frameworks, including FDA and EMA guidelines. Strong ability to assess clinical data and provide medical judgment in complex situations. Excellent communication and leadership skills, with the ability to work in a dynamic, fast-paced environment. Willingness to travel up to 20% for clinical and regulatory engagements. Core Competencies: Strategic thinking and problem-solving in clinical development. Strong interpersonal and cross-functional collaboration skills. Ability to interpret and present clinical data effectively. Expertise in regulatory interactions and clinical trial operations. Adaptability in a biotech environment with a focus on innovation and efficiency. #J-18808-Ljbffr Jobleads-US
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