Position: Chief Medical Officer/Medical Director
The Chief Medical Officer/Medical Director position is responsible for providing medical and scientific support to Biothera’s clinical development efforts in oncological immunotherapy projects. Plays a critical role in developing strategy and the design, conduct, analysis and reporting of Phase 1 – 3 studies.
Responsibilities
- Provide medical expertise and leadership to clinical and nonclinical activities of the Pharma Group.
- With senior Pharma leaders, evaluate and assess exploratory indications and market potential of compound; draft clinical development plans for Biothera’s proprietary compound.
- Conceive study designs, draft protocol synopses, and guide protocol writing.
- Oversee safety monitoring activities including data safety monitoring boards; evaluate clinical/safety data generated by studies; present clinical data/findings as required at internal/external/regulatory meetings.
- Work with cross-functional team members to facilitate data management, statistical analysis, and medical writing.
- Interact with participating clinical investigators at US/EU/Asian sites.
- Prepare and/or review regulatory submissions from clinical and safety aspect including INDs, Annual Reports, CSRs, and BLAs.
- As requested, conduct/participate on internal marketing/licensing teams.
- Develop and foster outside relationships with key opinion leaders, collaborating researchers, and research sites.
Candidate Qualifications
- Medical degree from accredited institution.
- Medical oncology board eligibility/certification.
- Experience with cancer immunotherapy, anti-tumor monoclonal antibodies and solid tumors.
- Relevant pharmaceutical/biotech experience (minimum 4 years), specifically clinical development of biologics.
- Strong verbal written and oral communication, problem solving, and interpersonal skills.
Travel Requirements
- Minimal travel; some international travel may be required.
Email resume to jobs@biothera.com. No calls please.