לוח אפשרויות קריירה - הדרך החכמה להייטק

The opportunity
Possible working locations: Haarlem (NL), Krakow (PL), Runcorn (UK), Bucharest (RO), Zagreb (HR)
Are you ready to shape the future of global clinical programs? As Director, Clinical Development, you will drive the development, execution, and management of cutting-edge clinical research across all phases, ensuring innovation and excellence at every stage.
Your Impact:•    Strategic Leadership: Oversee and guide study teams, leading cross-functional collaborations in a dynamic matrix environment.•    Autonomy & Influence: Take charge of key clinical research projects with full ownership of protocols, Investigator’s Brochures, clinical study reports, and regulatory submissions.•    Cross-Functional Excellence: Work closely with commercial, regulatory, pharmacovigilance, CMC, early clinical, and pre-clinical teams to shape and execute asset strategy.•    Regulatory & Industry Leadership: Play a pivotal role in steering INDs, NDAs, BLAs, and global regulatory filings, influencing the future of drug development.
Join us in driving meaningful advancements in clinical research. If you're a visionary leader eager to make a global impact, we want to hear from you.How you’ll spend your day
As a core member of the Global Project Team, as the Director of Clinical Development you will lead and oversee critical aspects of the clinical development process, ensuring the successful advancement of products through various phases. This role demands deep expertise in clinical development, strategic oversight, and cross-functional leadership.
Key Responsibilities•    Strategic Leadership: Develop, manage, and refine multiple Clinical Development Plans, ensuring alignment with company objectives and regulatory requirements.•    Cross-Functional Oversight: Lead and guide the clinical development team, collaborating with Global Clinical Operations to drive study implementation, resource planning, and trial execution.•    Regulatory & Compliance Excellence: Ensure clinical trials adhere to ICH, GCP, country-specific regulations, and company SOPs while managing safety concerns with Global Drug Safety and          Pharmacovigilance teams.•    Scientific & Medical Contribution: Represent the organization at investigator meetings, advisory boards, and scientific conferences, delivering impactful presentations.•    Operational Execution: Secure necessary human resources, oversee clinical drug supply logistics, and partner cross-functionally with key stakeholders including Regulatory Affairs, Toxicology, Biostatistics, and more.•    Regulatory Documentation & Submissions: Lead the preparation of critical regulatory documents (IND/NDA), with the capability to spearhead NDA submissions independently.•    Data Interpretation & Publication: Guide the interpretation of clinical results, ensuring high-quality reporting in collaboration with Medical Writing. Author and review abstracts, manuscripts, and presentations for scientific dissemination.