Senior Clinical Research Director, Rare

About This Role

Serve as the expert clinical lead for rare disease indications within R&D programs, driving breakthroughs and developing therapies for inherited disorders. Provide medical expertise, leadership, and organization skills to develop and execute clinical studies from early phases to life cycle management programs.

Responsibilities

• Provide medical expertise in the Study team to conduct the clinical studies from early phases to LCM programs
• Collaborate with medical and clinical scientific experts, Global Safety Officer, Regulatory Strategist, and other key functional representatives to deliver development strategy and prepare/assist with regulatory bodies interaction
• Develop the study level regulatory documentation (Abbreviated Protocol, Protocol, Amended protocol) for their project
• Lead operational development activities pertaining to study start-up (e.g. pressure test, competitive intelligence, patient engagement, cluster feasibility, study risk assessment)
• Provide appropriate medical input and support for all activities related to clinical studies conduct
• Develop the clinical part of Briefing regulatory documents, Common Technical Document for submission to regulatory bodies
• Be the medical reference in the Clinical Study team, ensuring the medical relevance of clinical data and acting as mentor for other DMDs/DSDs/CSs
• Lead and oversee the execution of clinical development and studies activities, ensuring compliance with GCP and regulations
• Represent the project in interactions with regulatory bodies, lead strategy, and write clinical sections of relevant documents
• Participate in and author manuscripts and abstracts, establishing collaborations with knowledge experts or advisory boards

Requirements

• 4+ years of clinical development experience in pharmaceutical industry, CRO, or healthcare institution
• Medical Doctor (MD) qualification
• Very good communication skills (verbal and written)
• Excellent problem-solving capability
• Demonstrated capability to challenge decision and status quo with a risk-management approach
• Quality-focused, able to develop good practices, using a critical data-driven and risk management approach
• Multiple tasks handling and prioritization
• Ability to negotiate to ensure operational resources are available for continued clinical conduct
• Mentoring skills and evaluation of resources performance capability
• Ability to work within a matrix model
• International/intercultural working skills
• Open-minded to apply new digital solutions
• Understanding of pharmaceutical product development and life cycle management
• Very good scientific and medical/clinical expertise
• Very good expertise in clinical development and methodology of clinical studies
• Acquired expertise (by training or experience) of interaction with Health Authorities

Qualifications

• Medical Doctor (MD) preferred, GP or specialist; training in pediatrics or pediatric neurology is a plus
• At least 4 years previous experience in clinical development in pharmaceutical industry or a CRO or medical experience in clinical development in an Healthcare institution

Nice to Have

• Training in pediatrics or pediatric neurology

Benefits