Located in Redmond WA, SystImmune Inc. is a bio-pharmaceutical company focused on the treatment of cancer through developing novel therapeutic bi-specific, and tri-specific antibodies, as well as antibody-drug conjugates (ADC's). Our objective is to create biologics that work through systematic intervention on the solid tumor micro-environment, to either directly attack the tumor and/or to activate the immune system to attack the tumor. We are a group of highly experienced immuno-oncology scientists utilizing several technology platforms to develop world class advanced antibody-based drug therapies.
Essential Duties and Responsibilities
- Provides strong regulatory guidance and support to assigned clinical development project teams in the development plan and implementation of regulatory strategy to maximize probability of regulatory success.
- Leads and/or participates in the formulation and implementation of project regulatory strategy.
- Identifies potential regulatory risks to the strategy/operations plan and propose risk mitigation options.
- Provides regulatory review and approve of clinical trial documents (e.g. trial protocols and reports, investigator brochures and regulatory submission packages, etc.) to ensure regulatory compliance.
- Serves as primary contact with FDA and other Regulatory Agencies, including preparing meeting and communications, to promote accelerated approval of original applications and supplements.
- Explains and communicates regulatory expectations to internal teams and external CRO to implement planned objectives in accordance with applicable regulations.
- Maintains current awareness of regulatory knowledge or new requirements across oncology areas and develops regulatory intelligence.
- Assists to develop regulatory strategy and update strategy according to regulatory change.
- Provides support for responding to regulatory authorities questions and prepares meetings with regulatory agencies.
- Willingness and ability to travel domestically and internationally, particularly China, as required (up to 25%).
Education and Experience
- MS or PhD degree in a scientific or medical discipline with a minimum of 15 years in regulatory affairs management and 10 years in a leadership role.
- Strong understanding of US and global regulations as they apply to pharmaceutical drug development.
- Demonstrates successful experience in the preparation and submission of INDs, BLAs, NDAs and other global clinical trial application development.
- Proven ability to plan and execute complex projects.
- Experience in directing interaction/negotiation regulatory agency (e.g. FDA) interactions and meetings.
- Proven ability to collaborate across departments and with outside investigators and CROs.
- Excellent written and verbal communication skills.