- Start date: September
- Location: Germany
- Contract Length: 12 months, very likely extension
- FTE: FTE
- Language: English and German are essential
- Project: Autoimmune, Cell Therapy
- Clinical Development Strategy: Develop and implement strategic plans for the clinical development of the Phase I-II autoimmune, cell therapy program, including study design, protocol development, and regulatory strategy.
- Protocol Development: Lead the design and development of clinical trial protocols, including selection of study endpoints, patient population, and treatment regimens, in collaboration with cross-functional teams and external experts.
- Clinical Trial Execution: Oversee the execution of clinical trials, including site selection, patient recruitment, and study conduct, to ensure adherence to protocol, regulatory requirements, and Good Clinical Practice (GCP) guidelines.
- Safety Monitoring: Monitor and evaluate the safety profile of the investigational therapy, including adverse event reporting, safety data review, and risk mitigation strategies, in collaboration with pharmacovigilance and safety teams.
- Data Analysis and Interpretation: Analyze clinical trial data, interpret study results, and communicate findings to internal stakeholders, external partners, and regulatory authorities in support of regulatory submissions and product development decisions.
- Regulatory Affairs: Provide medical input and support for regulatory submissions, including IND/CTA filings, protocol amendments, and responses to regulatory inquiries, to facilitate the approval and commercialization of the investigational therapy.
- KOL Engagement: Establish and maintain collaborative relationships with key opinion leaders (KOLs), academic researchers, and clinical investigators to advance scientific understanding, facilitate study enrollment, and support scientific exchange.
- Cross-Functional Leadership: Collaborate closely with cross-functional teams, including clinical operations, translational research, biostatistics, and manufacturing, to ensure seamless execution of the clinical development program and alignment with corporate objectives.
- Strong (5+ years preferred) experience in the field of Clinical Development
- Advanced degree in health sciences (PharmD, DNP, MD, or PhD) preferred
- Experience (3+ years preferred) working with Autoimmune Diseases or Advanced Cell Therapies preferred but not essential.
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Beschreibung
EPM Scientific are currently working with a key client with a cutting edge pipeline, who are urgently seeking a Consultant Medical Director to join their team. See a short summary below;
Contract Conditions:
Key Responsibilities:
Requirements
If this role is of interest to you, please apply directly to learn more.
