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Executive Director, Clinical Development
vor 2 Wochen
**Place in the Organization**
At uniQure, we are delivering on the promise of gene therapy and delivering hope for patients facing urgent unmet medical needs. Every role in our organization carries profound purpose; whether you're in research, operations, access, or support, your contributions impact patients. We're seeking passionate professionals who thrive in high-stakes environments, uphold rigorous quality standards, and share our relentless commitment to transforming the lives of patients. Join us in making the impossible possible, where your expertise becomes a catalyst for life-changing treatments.
The Executive Director, Clinical Development is responsible for providing clinical and medical leadership on gene therapy-based development programs at the clinical development stages. Their leadership covers a wide spectrum of responsibilities from study concept generation to design, implementation, and execution of clinical studies, and supporting submission to/approval from Health Authorities and Health technology assessments bodies, in collaboration with medical Affairs and market access to ensure commercial success. This role also supports the Research organization in the therapeutic area of expertise.
**Key result areas (major duties, accountabilities and responsibilities)**
- Lead the European clinical development plan for uniQure’s lead asset projects, serving as a clinical leader within the matrixed Core Project Team.
- Drive the design, implementation, execution, medical monitoring, and reporting of clinical studies across all development phases.
- Collaborate with other functions to shape the scientific and operational strategy for current and upcoming projects.
- Evaluate literature to inform patient population selection, outcome measures, and study design.
- Contribute core medical/scientific content to clinical documents (e.g., protocols, informed consent forms, clinical study reports, safety documents) to ensure high quality and compliance.
- Support clinical/scientific content for regulatory submissions and respond to medical/scientific inquiries from Health Authorities and IRBs/ethics boards.
- Organize and lead clinical advisory boards, data monitoring committees, and safety event committees.
- Support preparation for regulatory interactions and perform data mining/literature assessments to inform current and future projects.
- Lead or assist in preparing abstracts, posters, oral presentations, and other materials for scientific meetings and public distribution.
- Author development of protocols and provide input for associated documents (e.g., ICF/assents, eCRF, CRF guidance, statistical analysis plans).
**Qualifications and experience**:
- MD, PhD, PharmD, MS, or equivalent qualification.
- Minimum of 10 years in clinical development or clinical trials.
- Experience in neurodegenerative diseases, particularly in movement disorder diseases, is highly desirable.
- Experience in gene therapy is an advantage.
- A proactive and driven professional, energetic and passionate about achieving goals is a must.
- Strong collaborator and team player.
- Excellent communication skills.
- International work experience, especially within Europe and the US.
