Senior Clinical Research Director, Rare

Role Summary

Senior Clinical Research Director within the RARE Therapeutic Area, acting as the expert clinical lead for one or several indications in the development program. The role requires medical leadership, strong organizational skills, and a strategically and operationally focused, resourceful individual capable of creating synergies within the team and with external stakeholders, while delivering multiple operational tasks.

Responsibilities

• Provide medical expertise in the study team to conduct clinical studies from early phases to late development programs.
• Collaborate with medical and clinical scientific experts and other key stakeholders to deliver development strategy and support regulatory interactions.
• Develop study-level regulatory documentation and lead start-up activities such as feasibility, risk assessment, and engagement activities.
• Provide medical input and support for all clinical study activities, including responses to IRBs/health authorities and training materials.
• Develop the clinical content of regulatory submissions and responses to health authorities; act as medical reference within the Clinical Study team and mentor others by indication.

Qualifications

• Required: At least 4 years of experience in clinical development in the pharmaceutical industry or CRO, or medical experience in clinical development within a healthcare institution.

Skills

• Very good communication skills (verbal and written) for interactions across functions and with regulatory agencies.
• Excellent problem-solving capability and a risk-management approach.
• Ability to manage multiple tasks, negotiate for resources, and work within a matrix organization.
• Mentoring and evaluation of resources, and ability to collaborate across international, intercultural contexts.
• Open-mindedness to apply new digital solutions; strong scientific and medical/clinical expertise; expertise in clinical development methodologies; interaction with Health Authorities.

Education

• Medical Doctor (MD) preferred: GP or specialist; training in pediatrics or pediatric neurology is a plus