Director, Medical Monitor

Job Responsibilities:

• Serve as the primary medical and safety contact for assigned clinical trials, ensuring adherence to protocols by both internal and external investigators and study teams.
• Act as the main point of contact for all medical-related inquiries from investigators, regulatory agencies, and internal/external teams, ensuring consistent interpretation and clarification of protocols.
• Monitor clinical trials to safeguard participant safety, ensure data accuracy, and confirm protocol compliance, addressing any medical issues that arise.
• Oversee the review, assessment, escalation, documentation, and reporting of adverse events (AEs), serious adverse events (SAEs), and other safety-related events.
• Support the clinical development of assigned programs and participate in the design and execution of development strategies; provide strategic clinical science support for assigned studies and programs.
• Lead conference calls with investigators to discuss inclusion/exclusion criteria and assist with site selection and patient recruitment efforts.
• Assist in the design and execution of assigned clinical trials and/or programs, collaborating closely with clinical operations study leads and cross-functional study team members to carry out clinical trial activities.
• Support medical monitoring activities, associated documentation, and represent the clinical sciences organization on relevant sub-teams and forums. Act as the primary point of contact for clinical science-related activities, conduct ongoing medical/safety data reviews, and provide clinical science input into study reporting.
• Engage in external interactions with health authorities and regularly collaborate with internal and external partners, including cooperative groups, key opinion leaders (KOLs), clinical investigators, scientists, and multidisciplinary teams.
• Work cross-functionally to develop protocol and informed consent form (ICF) documents/amendments, presenting these to governance committees and early clinical development teams as required.
• Develop and/or provide input into clinical presentation slides and other materials for internal/external meetings (e.g., DSMB, EOC, site training, and investigator meetings), as well as ongoing communications in collaboration with Clinical Science Physicians.
• Lead the development of clinical contributions to internal documents and presentations for assigned studies, including clinical study reports (CSRs) and regulatory documents (e.g., Investigator’s Brochure (IB), DSUR, PSUR, Orphan Annual Reports, and responses to health authorities), as well as external publications (abstracts, posters, manuscripts).

Job Requirements:

• Medical Degree (MD or DO) required.
• Expertise in Oncology/Hematology.
• Minimum of 10-15 years of experience in the pharmaceutical/biotech industry, or relevant clinical or laboratory research experience.
• At least 6 years of experience in clinical trials in the role of Medical Monitor.
• Proven experience in clinical trial safety monitoring, adverse event reporting, data review, and regulatory interactions/responses.
• In-depth knowledge of current Good Clinical Practices (cGCP) and clinical trial design; comprehensive understanding of the global drug development process.
• Familiarity with the external regulatory environment, including FDA, EMA, and other global requirements related to clinical development.
• Demonstrated ability to work independently and exercise sound medical and clinical judgment to resolve critical issues not always addressed by existing standards, policies, and procedures.