Senior Director, Clinical Development

Senior Director, Clinical Development — Role Responsibilities
- Provide clinical and medical oversight and guidance for gene therapy-based development programs at clinical development stages.
- Collaborate with the VP and Clinical Development Leader on clinical development strategies and study concept generation.
- Design, implement, execute, and oversee clinical studies across pipeline phases; ensure compliance with applicable regulations, SOPs, and internal guidelines.
- Submit to/seek approval from Health Authorities and Health technology assessment bodies (in collaboration with Medical Affairs and Market Access) to support commercial success.
- Support the research organization in the therapeutic area of expertise and help identify current and future pipeline needs.
- Act as internal and external subject matter expert for Huntington’s Disease and other undisclosed programs.
- Represent and defend assigned programs in matrixed Core Project Teams.
- Proactively identify program risks and implement mitigation strategies.
- Provide medical expertise internally across responsible project activities.
- Provide medical expertise externally based on scientific review of product data and consultation with internal/external experts.
- Organize and lead medical aspects of clinical advisory boards and study-specific committees (steering, data monitoring, safety event).
- Cross-functionally develop CDP, clinical protocols, investigator brochures, target product profiles, IND reports, safety reports, and clinical study reports.
- Interpret and analyze clinical trial results (e.g., PK/PD, lab, neuroimaging, antibody data); review/approve clinical trial coding and safety monitoring with pharmacovigilance.
- Participate in scientific advice meetings with EMA, FDA, and other regulatory bodies.
- Continually review and analyze disease-specific medical literature.
- Supervise preparation/delivery of abstracts, posters, conference presentations, and manuscripts for peer-reviewed journals.
- Interface with Research to bring a medical disease perspective and unmet-need analysis to differentiate gene therapy candidates and identify opportunities beyond initial AAV indication.
- Conduct focused medical review of emerging pre-clinical candidates at Stage Gate #1 and design an early high-level clinical development plan.
- Collaborate with Commercial on disease incidence/prevalence of orphan indications and ensure alignment with commercial expectations.
- With Business Development, support company due diligence for potential in-licensing of pipeline gene therapy programs.

Qualifications & Skills
- MD with at least 7 years post-qualification clinical research experience in a Pharmaceutical/Biotech company (investigator experience is a plus).
- Proven record leading and managing teams.
- Deep knowledge of drug development and clinical trial processes.
- Excellent knowledge of regulatory requirements/ICH guidelines.
- Demonstrated experience working across multiple project teams through late-stage development and submission.
- Experience interacting with Health Authorities (FDA, CHMP/EMA, PMDA Japan).
- Clinical research experience in at least one indication within the assigned therapeutic area (preferred).
- Strong organizational, problem-solving, interpersonal, and communication skills; hands-on, results-driven, and sense of urgency.
- Experience negotiating with key stakeholders to gain buy-in.
- Global thinking and ability to understand the big picture.
- Excellent written and spoken English communication.
- Ability to meet strict deadlines; manage competing priorities and changing demands.
- Sound time management; strong attention to detail and accuracy while maintaining high-quality GCP standards.
- Flexibility with changing process demands; willingness to learn and support across service lines.
- Ability to build effective relationships across culturally diverse teams; create buy-in from functional groups.
- Confident, independent, decisive self-starter with high performance standards.
- Understanding of and willingness to meet regulatory, quality, and compliance standards; high integrity with ethics and scientific standards.
- Willingness to travel (domestic/international ~30%) to oversee trials, meet investigators, attend conferences, and participate in advisory boards.