Related skills
regulatory affairs biostatistics clinical trials medical writing clinical developmentπ Description
- Lead regulatory strategy for autoimmune and/or oncology programs.
- Drive clinical development across drugs, biologics, and cell/gene therapies.
- Provide medical and strategic support for global business development.
- Develop and revise protocols, CRFs, analysis plans, and IND/NDA docs.
- Ensure high quality, data-driven deliverables with scientific integrity.
- Collaborate with senior leadership and clients to drive timelines.
π― Requirements
- MD/MBBS or equivalent; fellowship; board cert preferred.
- 10+ years senior leadership in clinical research.
- Experience with US/EU Regulatory Authorities.
- Knowledge of safety reporting globally.
- Ability to travel domestically and internationally.
- Strong strategic, medical and regulatory communications.
π Benefits
- Discretionary annual bonus
- Health insurance and wellbeing benefits
- Retirement savings plan
- Life and disability insurance
- Parental leave
- Paid time off
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