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 Barrington James Limited
...Are you ready to take complete ownership of the supply chain function, including logistics, inventory, and warehousing, for a successful company in motion? This is a newly created position resulting from growth, and it requires someone who is committed to delivering an...
...commercial and residential locations; including retail locations, office buildings, and malls from 1 to 3 stories. Some ladder work, travel between jobs, and minimal paperwork are required. You need reliable transportation, proof of insurance, and a valid driver's...
$20-$24/hour plus bonuses! Great part-time opportunity! Sares Regis Group of Newport Beach, California, is a privately held real estate development, investment and management firm that focuses on commercial properties and multifamily communities in the western U.S. Since...
...or above required. Three Clinical Pastoral Education (CPE) units required. Four CPEs preferred. One Unit = 400 hours, 300 clinical ministry, 100 group experience under supervision of certified supervisor of CPE program. Ordained, licensed, or commissioned to function in...
...itinerario establecido Orientar a los clientes sobre los productos disponibles con el fin de impulsar la compra del mismo Gestionar las... ...personal de la tienda Respetar y acatar las polticas de trabajo Ejecutar promociones a clientes y a vendedores de tienda...