Position: Medical Monitor
The Medical Monitor (MM) position is responsible for providing medical guidance and overseeing patient safety for Biothera’s clinical studies. In addition, the MM will provide scientific support to Biothera’s clinical development efforts in various oncology projects. Plays a critical role in developing strategy and the design, conduct, analysis and reporting of Phase 1 – 3 studies.
Responsibilities:
• Be accountable for safety across all studies including conducting safety reviews; resolving safety issues; interacting with Principal Investigators, CRO staff, regulatory bodies, and Data Safety Monitoring Boards; and guiding safety decisions.
• Be responsible for implementing a central safety database including evaluating safety database systems, implanting selected database, and working with CRO staff to maintain database.
• Participate in study design and protocol development, safety plan generation, and IND/CSR/Annual Report writing as part of Clinical team.
• Perform safety level data review; work with statisticians to generate listings and analyses; review patient narratives including CRFs, laboratory reports and other pertinent data; review coding and final data prior to data lock.
• As requested, conduct in-house, CRO, or site training and participate on internal marketing/licensing teams.
• Develop and foster outside relationships with key opinion leaders, collaborating researchers, and research sites.
Candidate Qualifications:
Preference will be given to candidates with the following qualifications:
• Medical degree from accredited institution
• Medical oncology board eligibility/certification
• Relevant pharmaceutical/biotech experience (minimum 4 years)
• Strong verbal written and oral communication, problem solving, and interpersonal skills.
Travel Requirements:
• Minimal travel; some international travel may be required