Job description
LuminaCura Therapeutics is seeking a Senior Medical Director to lead medical strategy for its Specialized Medicine portfolio. The ideal candidate will combine deep scientific expertise with strategic leadership to advance novel therapies for rare and complex diseases.
In this high-impact role, you will collaborate with R&D, Regulatory, Market Access, and Commercial teams to shape clinical development plans, medical communications, and post marketing activities that improve patient outcomes.
We offer a premium, growth-minded environment with competitive compensation, comprehensive benefits, and a strong emphasis on work-life balance.
Responsibility
- Lead the medical strategy and execution for the Specialized Medicine portfolio, aligning with R&D, Regulatory, and Commercial teams.
- Oversee protocol development, trial design, and execution; drive real-world evidence and translational research efforts.
- Serve as medical lead for regulatory interactions, medical review, and risk management for development programs.
- Build and sustain relationships with key opinion leaders, investigators, patient groups, and external partners.
- Collaborate with Clinical Operations, Biostatistics, and Market Access to ensure robust data, publications, and communication plans.
- Oversee medical communications, publications strategy, medical education initiatives, and scientific exchange activities.
- Ensure compliance with regulatory standards, GxP, ICH guidelines, and ethical medical practices across all activities.
- Guide lifecycle planning and post-marketing evidence generation to support product value and patient outcomes.
Qualification
- MD or DO or PhD in life sciences; board certification in a relevant specialty preferred.
- 5+ years of experience in specialized medicine, rare diseases, or related therapeutic areas; strong clinical development and medical affairs background.
- Proven leadership abilities with cross-functional collaboration and people management.
- Demonstrated experience engaging KOLs, investigators, and senior leadership; strong scientific communication and publication track record.
- Experience with regulatory submissions, medical strategy development, and medical review processes.
- Solid understanding of clinical trial design, endpoints, statistics, and evidence generation; working knowledge of GCP and ICH guidelines.
- Excellent written and verbal communication skills; ability to translate complex data into external communications.
- Ability to travel as needed (approximately 20-30%).