Responsibilities
- Lead clinical science strategy and direction for the clinical development function.
- Serve as medical leader for internal cross-functional teams, including pharmacovigilance, biostatistics, clinical operations, and regulatory affairs.
- Oversee medical safety aspects of clinical development initiatives.
- Work with pharmacovigilance teams to evaluate safety data from clinical trials.
- Partner closely with Clinical Operations to ensure trial execution meets timelines and deliverables.
- Design and author clinical protocols and related study documentation.
- Author clinical and safety content for key regulatory documents such as INDs, IBs, CSRs, DSURs, BLAs, and other submissions.
- Prepare, analyze, and present safety findings to internal and external safety monitoring committees.
- Lead clinical data presentations and support development of abstracts, posters, and presentations.
- Support publication planning and manuscript development.
- Follow company SOPs and comply with ICH, GCP, and applicable regulatory standards.
- Provide medical expertise during internal audits and regulatory inspections.
- Help prepare materials for advisory board and executive leadership meetings.
- Foster strong internal collaboration across departments.
- Represent the organization externally with investigators, key opinion leaders, and other stakeholders.
Benefits
- Comprehensive medical, dental, vision, 401k, and additional benefits
- Unlimited paid time off
- Parental leave policy
- Equity and supplementary compensation included in total rewards package
Compensation
Equity and supplementary compensation included in total rewards package
Team
Reports to the Chief Operating Officer
Team
Reports to: Chief Operating Officer
