Medical Director, Clinical Development
- Employer
- Catalyst Biosciences, Inc.
- Location
- South San Francisco, CA
- Start date
- Jun 27, 2019
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- Discipline
- Clinical, Clinical Development, Clinical Medicine, Clinical Testing/Monitoring, Clinical Trials
- Required Education
- Doctorate/PHD/MD
- Position Type
- Full time
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Responsibilities
- Act as a product and disease area expert and point of contact for other members of the team, working cross functionally with all the disciplines engaged in drug development activities, such as pre-clinical, CMC, QA,, regulatory, medical affairs, biostatistics/data management, pharmacovigilance, medical writing, and clinical operations.
- Design and execute clinical trials
- Support writing clinical trial protocols
- Serve as a Medical Monitor for clinical trials, which could include assistance with site identification and communication, attendance at investigator meetings, development and participation in advisory boards, and data review
- Assist with development of EDC, data analysis and presentation internally and externally
- Contribute to drafting and reviewing clinical documents, abstracts, presentations, manuscripts, and regulatory submissions, such as investigator brochures, clinical study reports, protocols, IND’s, BLA’s, MAA’s and informed consent forms.
- Cultivate relationships with key opinion leaders to represent the interests of the company
- Work closely with Regulatory affairs in communications with health authorities, briefing books, and regulatory pathway submissions
Requirements
- Excellent communication skills (interpersonal, written and verbal)
- Must be well organized, polished, proactive, detail-oriented, mature and have a professional demeanor
- Ability to multi-task and work efficiently in an environment with changing priorities
- Demonstrate independence
- Act with the highest integrity
- Experience in a start-up environment
- Travel time is 15-20% to investigative and CRO sites, regulatory agencies, and hematology meetings
Education and Training
- Medical Degree required
- At least 5 years of industry or academic experience; at least 3 years of experience with clinical trial design and execution
- Experience in rare disease, especially benign hematology and hemophilia is preferred
- Specialty training in hematology a plus
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