Medical Director, Clinical Development #4003

Responsibilities:

• Act as a medical monitor for designated clinical and/or real-world evidence studies, serving as a member of the cross-functional clinical study management team
• Issue queries and communicate with clinical study site staff to ensure completeness and accuracy of clinical data
• Prepare and review answers to safety queries from regulatory authorities and IRBs as needed
• Collaborate with other medical directors, clinical scientists, clinical data managers, biostatisticians, data scientists, and other functional stakeholders on the design, conduct, and analysis of clinical studies
• Collaborate with colleagues from biostatistics to develop statistical analysis plans and serve as a co-author on clinical study reports and other study deliverables
• Contribute to the development and preparation of regulatory documents
• Provide scientific and medical support for publications and presentations to ensure scientific and medical accuracy and cross-functional alignment
• Support efforts to advance clinical development and scientific research plans (review and interpretation of study data; engagement of key opinion leaders; providing strategic and scientific input to study-level and program-level teams)
• Develop formal networks with external investigators and thought leaders to support clinical study programs
• Ensure compliance with industry regulations, policies, guidelines and standards

Preferred Qualifications:

• MD required, board certified/board eligible in oncology strongly preferred
• 2 + years of clinical practice experience
• 3 + years of experience in a diagnostics or pharmaceutical Clinical Development setting
• Experience in designing and conducting clinical studies, particularly registrational and/or clinical utility studies for reimbursement
• Prior experience in a medical monitoring role strongly preferred, including medical case review and assessment of adverse event reports to determine seriousness and reportability
• Experience in oncology, genomics, diagnostics, cell-free DNA-based applications, or similar applied medical fields is strongly preferred
• Familiarity with the development of real-world evidence from real-world data (e.g., healthcare claims or electronic health records)
• Knowledge of regulatory requirements (e.g. ICH, GCP, HIPAA, ISO) and a commitment to compliance
• Experience authoring Standard Operating Procedures (SOPs) and similar documents in support of the role and responsibilities of a Medical Director
• Excellent verbal and written communication skills, including clear and confident presentation skills
• Ability to network and partner within external investigator and national organizations
• Results oriented and strong attention to detail
• Strong leadership and collaboration skills