Director, Regulatory
Description
Summary:
Lumen Bioscience is a privately held, clinical-stage biopharma company. Unusually for a modern biotech, Lumen is vertically integrated: everything from hit-to-lead discovery through GMP manufacturing and regulatory affairs is operated directly out of its Seattle campus. There is very little outsourcing to CDMOs and consultants compared with most biotechs.
Lumen was founded in 2017 with a vision to use genetically engineered spirulina—the common food algae sold in grocery stores—to make and deliver biologic drugs (mostly protein therapeutics) directly to gastrointestinal, airway, and topical surfaces. These biologic drugs include antibodies, peptides, enzymes, cytokines, and recombinant vaccine antigens. Therapeutic areas of interest encompass infectious diseases, cardiometabolic diseases, inflammatory diseases, and enzyme deficiencies.
The Head of FDA Regulatory Affairs will play a leading role in assembling regulatory submissions to the FDA and overseas governmental agencies. As of this writing, Lumen has two open INDs with the FDA and three active clinical trials in the U.S. and Australia, including the RePreve Study with LMN-201 (NCT05330182). Several additional clinical trials are in planning. This position requires comprehensive knowledge of FDA regulations and a strategic mindset capable of leading Lumen through its first BLA submission and beyond.
Essential Duties and Responsibilities
The following activities will be key to a successful first six months at Lumen:
- Interactions with Regulators: Serve as the primary contact for FDA and other regulatory authorities. Prepare teams and coordinate for regulatory meetings (pre-IND, end-of-phase, pre-BLA, etc.).
- Regulatory Submissions: Lead preparation, review, and submission of regulatory documents, including INDs, BLAs, NDAs, annual reports, meeting requests, and other regulatory filings with the FDA and other regulators. These submissions require working closely with Lumen’s CEO and heads of clinical, R&D, quality, and GMP manufacturing as appropriate.
- Regulatory Intelligence: Monitor and analyze regulatory landscape, industry trends, and competitor activities. Provide strategic insights and recommendations to the leadership team regarding regulatory implications for product development and commercialization. The novelty of Lumen’s products and GMP biomanufacturing process create many opportunities to think creatively about improving conventional biopharmaceutical development, including the regulatory process. We do not want to overlook these.
Once up to speed on Lumen’s technology platform and regulatory history:
- Regulatory Strategy: With the CEO and heads of clinical, R&D, quality, and GMP manufacturing, further develop Lumen’s regulatory strategy for the pipeline, including new drug programs and additional regulatory jurisdictions (may include the E.U., Japan, China, and WHO).
- Leadership and Supervision: Build and lead Lumen’s regulatory affairs team as the size and complexity of Lumen’s clinical portfolio grows.
- SOP Development and Implementation: Begin to develop automated tools and standard operating procedures (SOPs) for recurring regulatory affairs activities, with an eye toward improving both efficiency and execution precision.
Depending on prior experience and interests, the following may or may not also be relevant to the role over the long term:
- GMP & GCP: Lumen directly operates two GMP manufacturing facilities at its Seattle R&D/GMP campus. Initially the quality assurance and quality control functions and clinical data quality will remain in their existing reporting structures, but this may evolve.
Qualifications and Requirements
- Bachelor’s degree.
- Advanced degree in a scientific, healthcare, or related field preferred. Lawyers with experience in FDA law are encouraged to apply.
- Minimum of 10 years of experience in regulatory affairs in biopharmaceuticals.
- Deep knowledge of:
- drug regulations (FDA, ICH, etc.); familiarity with GMP, GCP, and GLP; and
- regulatory filings, including INDs, BLAs, NDAs, and post-approval activities.
- Experience managing the process of drafting and submitting regulatory submissions, including FDA.
- Project lead experience preferred.
- Experience with the Australian regulatory process is helpful but not strictly necessary.
- Proven ability to develop and execute regulatory strategies, navigating complex regulatory landscapes and achieving successful regulatory outcomes.
The successful employee will have the following attributes:
- Strong leadership skills, fostering a collaborative and high-performing team environment.
- Strong writing and editing skills; particularly helping others learn to write in “FDA regulatory style,” including some for whom English is not the first language.
- Strong negotiation skills in interactions with regulatory authorities and internal stakeholders.
- Impatience for the slow pace and extreme cost of conventional biopharmaceutical development; a distaste for mindless proceduralism for its own sake.
- A willingness to “roll up the sleeves” and dive into the work deeply; comfort with operating in a lean staffing environment without Big Pharma staffing levels.
- Deep understanding of the fundamental basis of FDA and other regulatory systems, and the ability to use this not just to copy regulatory precedents, but instead develop regulatory strategies from first principles, highly tailored to each product’s unique biological and clinical attributes.
- Detail-oriented personality.
- Continuous learner; passion for staying up with evolving regulatory requirements and best practices.
This is a full-time position with a salary range of $150,000 to $200,000 + stock bonus. The base salary range represents the anticipated low and high end of the salary range for this position. Individual placement within a salary range will vary based upon factors including but not limited to a candidate’s skillset, experience, knowledge, education, and performance.