Position: Chief Medical Officer/Medical Director/Safety Officer
This position is responsible for providing medical guidance and overseeing patient safety for Biothera’s clinical studies. In addition, the Chief Medical Officer/Medical Director/Safety Officer 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
Send resume to jobs@biothera.com. No calls please.