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Lumen Bioscience

1441 N. 34th St, Ste 300

Seattle, WA 98103

Open Position: Head of Pre-Clinical Development

STATUS:               Full-time, regular

REPORTS TO:      Chief Scientific Officer

Company Background

Lumen Bioscience develops orally delivered therapeutics for diseases of the G.I. tract. Its initial programs are in infectious disease, an area with well validated biological targets, significant unmet clinical need, readily available nondilutive financing, and straightforward regulatory paths. Lumen is VC-backed and commercially-minded, but enjoys considerable funding support from the Bill & Melinda Gates Foundation and the NIH.


Beyond this initial focus on infectious disease, we believe that the G.I. tract is full of therapeutic targets that have proven intractable for traditional drug development tools (e.g. small molecules, infusion antibodies, and vaccines). These longer-term opportunities include well-validated targets in inflammatory diseases (such as IBD and celiac disease), and other opportunities emerging from the large and rapidly growing scientific literature on the importance of the microbiome for human health.


Lumen’s first targets are C. difficile, norovirus and traveler’s diarrhea (campylobacter and E. coli). Research dating back decades for each of these supports Lumen’s therapeutic approach: oral delivery of large volumes of antibodies that neutralize the pathogen or its toxins. This therapeutic approach has been shown to be technically feasible in research dating back decades, including several successful trials in human subjects. Lumen’s technology allows — for the first time — therapeutic monoclonal antibodies to be manufactured and delivered at a cost that makes such products commercially feasible. Adding credibility to this bold claim, Lumen has built a large-scale manufacturing plant that has been operating under cGMP controls since late summer 2018, with third-party certification audits completed in January 2019.

Position Summary

 

The Head of Pre-clinical Development is a highly influential R&D team leader who will spearhead Lumen’s next wave of orally delivered therapeutics.


This position requires a professional with a strong background in pre-clinical drug development (hit to lead to IND), and a nimble, creative attitude toward the early-stage drug development process. The current team consists of several scientists and technicians, as well as a wide range of external resources e.g., CROs, academic collaborators, and key opinion leaders). Reporting structures will be worked out appropriately based on the successful candidate’s prior managerial experience, interests, and aptitude, but it is expected to comprise 6-12 team members altogether. As we continue to develop clinical assets and the team expands, there will be additional duties and responsibilities.

 

Essential Duties and Responsibilities

The major tasks for this position are as follows:

  • Leading a team of junior and senior scientists and technicians to design, engineer, optimize and validate neutralizing antibody therapeutics for oral delivery

  • Working at the interface between discovery and clinical trials

  • Working closely with the CSO and Lumen’s core services groups, overseeing Lumen’s therapeutic discovery activities:

    • helping to develop discovery strategy for new targets

    • drafting preliminary target product profiles

    • building external collaborations as necessary for preclinical development

    • hit identification and in vitro characterization

    • lead optimization

    • cell-line establishment

    • designing and executing proof-of-concept experiments to translate early in vitro findings

    • IND-enabling studies

  • Working with Lumen’s CMO, head of regulatory affairs, and head of manufacturing:

    • quickly attaining a functional awareness of the key regulatory considerations that are implicated in various kinds of early-stage drug development decisions, acknowledging that the unique context of Lumen’s products (orally delivered biologics) frequently throws up many novel questions that are not as clearly worked out in the relevant FDA/ICH guidance

    • planning and participating in pre-IND meetings (pharmacology sections)

    • drafting and filing new IND submissions (collaborating with the CMO and head of regulatory affairs)

    • providing programmatic support throughout the clinical trial process

  • Building on existing processes, continue to develop Lumen’s institutional capacity for R&D data generation and recordkeeping in accordance with commercial biopharma industry best practices

  • Working with inside and outside legal counsel, identifying opportunities to seek patent protection and ensure trade-secret protection

  • For new therapeutic targets, identifying the best available in vitro and in vivo animal models 

  • Recruiting, retaining, and developing a team of scientists that will deliver timely, high-quality data that tightly supports Lumen’s strategic business goals

  • Supporting Lumen’s continued success in garnering non-dilutive funding for its research, which to date includes funding support from the Bill & Melinda Gates Foundation, the Wellcome Trust, the NIH, USDA, and the US Department of Energy

Qualifications & Requirements

 

Education and Experience

  • PhD in a biotechnology, medical, or related field

  • Minimum of 6 years' drug development experience with a minimum of 4 years in biologics

  • Relationships with biopharma companies and/or thought leaders in a field targeted by one of Lumen’s lead pipeline products

  • 5 or more years of team leadership experience with evidence of progression

  • Experience in writing and authoring IND pharmacology sections

  • Understanding of the impact that preclinical program decisions can have on a product’s ultimate commercial success

  • Additional desirable education and experience:

    • Experience working with protein biologics 

    • Experience in a medium to large commercial-stage biopharma company

    • Experience participating in PDUFA meetings with FDA staff (pre-IND, EOP, pre-BLA, etc.)

 

The successful candidate will have the following attributes:

  • Prioritize productive collaboration among all discovery functions while maintaining an independent scientific approach that ensures the highest data quality and robustness

  • Strong attention to detail and organizational skills

  • Self-starter, able to contribute effectively in a fast-changing environment

  • Be a champion for Lumen’s scientific values

  • Work as a strong team player with the ability to partner effectively with large internal teams, cross-functional experts, and external collaborators

  • High integrity and ethics, and a focus on patient safety and well-being

  • Commitment to quality and timely delivery of results

  

Application Instructions

Please submit a resume and cover letter to jobs@lumen.bio with the job title in the subject line.


This position is available immediately. Applications will be reviewed upon receipt. Only successful applicants will be contacted.

About Lumen

Based in Seattle, Washington, Lumen Bioscience has developed proprietary technologies for synthesizing high-value products in a novel platform organism. Lumen completed its Series A financing in mid-2017 and is using these technologies to produce novel products that solve long-standing problems in human and animal health and nutrition, working out of a beautiful lab and office facility overlooking Lake Union in Fremont.  At Lumen, you’ll be challenged, you’ll be inspired, and you’ll be proud to be part of an innovative organization making a real impact on improving the quality of life globally.

Lumen is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.


NOTE TO EMPLOYMENT AGENCIES: Lumen values its relationships with recruitment partners and will only accept resumes from those partners that have been contracted by a member of the human resources team. Lumen is not responsible for any fees related to resumes that are unsolicited or are received by any employee of Lumen who is not a member of the human resources team.