Medical Director
About the job
• Leading the direction, planning, execution of clinical trials and interpretation of clinical data
• Establishing scientific methods for design, implementation of clinical protocols, and ensuring trial subject safety
• Leading clinical trials, phases I - IV, for company products under development
• Building and managing the clinical research scientist team supporting clinical trials and overseeing CROs and other vendors
• Building reliable relationship with clinical investigators, discussing trial design, leading investigator’s meetings and advisory boards
• Monitoring safety and reporting adverse events
• Coordinating and developing information for reports submitted to the FDA and other health authorities and representing the Company at different forums
• Monitoring adherence to protocols and determining study completion
• Reviewing clinical data and leading/authoring reports and study related documents, such as IBs, study protocols, publications and regulatory filings including briefing documents, reports, and IND/BLA submissions
• Evaluating products for in/out licensing
• Participating in cross-functional teams, working in a highly matrixed team environment to advance preclinical programs to clinical evaluation
• Staying abreast on the clinical development and regulatory issues related to other competitive or relevant compounds in development and providing recommendations on changes needed to our strategy or clinical development plan as a result
• Provide medical review, assessment and interpretation of clinical data reported in clinical study reports to ensure that the data are correct and presented with the appropriate medical interpretation
• Adhere to both Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) aligned with the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH)
• Ensure consistent practices with the highest ethical standards in compliance with internal SOPs, local regulations, and laws
Requirements
- MD degree or equivalent
- Hematology expertise
- Prior experience in cell therapy products
- Experience in clinical trial planning and implementation
- Experience or exposure to FDA/EMA/PMDA/ or other regulatory agencies interactions
- Excellent verbal and written communication skills
- Contributing to the Clinical Strategy and Clinical Development Plans for the Company’s assets
- Proven ability to work independently, as well as to collaborate with peers and work effectively in a fast-paced team-oriented environment
- Strong organizational, time management, communication, and interpersonal skills
- Capable of managing multiple diverse projects simultaneously
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Hard Skills
- clinical trial planning
- clinical trial execution
- clinical data interpretation
- clinical protocol design
- regulatory submissions
- adverse event reporting
- medical review
- cell therapy expertise
- clinical strategy development
- project management
Soft Skills
- leadership
- communication
- organizational skills
- interpersonal skills
- time management
- collaboration
- independence
- team-oriented
- relationship building
- problem-solving
Certifications & Qualifications
- MD degree
- Good Clinical Practice (GCP)
- Good Pharmacovigilance Practice (GVP)
- ICH compliance
