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Director Clinical Development - Respiratory
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.
Job
• 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.
Profile
• Advanced Medical & Scientific Expertise: MD, DO, or equivalent education combined with relevant industry experience. Exceptional PhD, PharmD, and DVM candidates with a proven leadership track record will also be considered.
• Strategic Clinical Leadership: experience in pharmaceutical industry or clinical trial management, with demonstrated ability to lead teams and drive projects forward. MD/DO candidates with deep clinical trial knowledge will also be considered, even without prior industry experience.
• Therapeutic Expertise: Strong preference for Respiratory, Pulmonary, or Allergy therapeutic areas, with an ability to shape research strategies and drive advancements.
• Influential Communication & Decision-Making: Exceptional interpersonal, verbal, and written communication skills to effectively collaborate with global cross-functional teams and present strategic insights.
• Agility & High-Performance Leadership: Ability to thrive in a dynamic, fast-paced environment, managing multiple priorities under time-sensitive conditions while maintaining a clear vision for success.
Company profile
Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.
