Life Scientist - Clinical Development (m/f/d)
Core
Lead global clinical development programs for autoimmune and immunology therapies, overseeing Phase I-III trials and strategic lifecycle management.
Role type
Senior clinical scientific program lead
Builds
Integrated clinical development programs, Clinical Development Plans (CDPs), Target Product Profiles (TPPs), and regulatory submission strategies
Domain
Biopharmaceuticals, Autoimmune diseases, Immunology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Global clinical development strategy (Phase I-III), Asset evaluation and due diligence, Regulatory interaction (EMA/FDA), Cross-functional team leadership, Clinical Development Plan (CDP) design, Target Product Profile (TPP) development
Preferred skills
Indication extension strategy, Territory expansion planning, Pharmacology expertise
Technologies
GCP/ICH regulations
Responsibilities
Lead global clinical development programs across Phase I-III trials, Design and drive efficient, integrated clinical development strategies, Conduct due diligence and evaluation of new assets, Serve as key medical interface with regulatory authorities, Oversee development and quality of core clinical and regulatory documents
Seniority
Senior, hands-on IC
