Head of Companion Diagnostic Development

Location
San Diego, California
Posted
Jan 14, 2022
Ref
oKEdifwD
Discipline
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time

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Head of Companion Diagnostic Development - San Diego, CA

 

We’re a different kind of biotech company.  And we’re here to make a difference.

 

Prometheus Biosciences, Inc. (Nasdaq: RXDX), is a clinical-stage biotechnology company pioneering a precision medicine approach for the discovery, development, and commercialization of novel therapeutic and companion diagnostic products for the treatment of immune-mediated diseases.  The Company’s precision medicine platform, Prometheus360™, combines proprietary machine learning-based analytical approaches with one of the world’s largest gastrointestinal bioinformatics databases to identify novel therapeutic targets and develop therapeutic candidates to engage those targets. Prometheus Biosciences is headquartered in San Diego, CA. 

 

The Company’s lead candidate, PRA023, is an IgG1 humanized monoclonal antibody (mAb) in development for the treatment of immune-mediated diseases, including ulcerative colitis (UC), Crohn’s disease (CD), and a recently announced third indication, systemic sclerosis-associated interstitial lung disease (SSc-ILD).  The Company is currently conducting a Phase 2 trial in UC patients and a Phase 2a trial in CD patients, each utilizing a genetics-based companion diagnostic designed to identify patients who are predisposed to increased expression of TL1A and therefore potentially more likely to respond to PRA023.  The company also plans to initiate a Phase 2 clinical trial for PRA023 in SSc-ILD in the first quarter of 2022.

 

Summary

Working in close collaboration with the executive team and reaching across multiple functional areas, the Head of CDx Development will lead all companion diagnostic product planning and development activities, from assay development all the way through PMA approval.

 

This critical development leader will interface closely with the biomarker discovery and clinical development teams; articulate CDx product requirements and designs; manage internal resources, external consultants and CROs in assay and software development; ensure alignment with regulatory requirements; and interface with FDA toward PMA approval.

 

Importantly, this leader will be breaking new scientific ground with the first companion diagnostics for inflammation and gastrointestinal therapies.  The successful candidate should be comfortable working with FDA to define regulatory paradigms for these novel products and building scalable infrastructure to support continued CDx development for a growing therapeutic pipeline.

 

This is a unique opportunity to join a top-tier organization pioneering precision medicine approaches in a large market with a dire unmet need and setting the scientific foundations to build a leading global precision therapies company.

 

Additional Responsibilities

  • Lead all Companion Diagnostic product planning and development activities
  • Foster close cooperative relationships with all functions inside and outside of the company to establish product plans and strategies, product specifications, resource planning, manufacturing scale-up, process adherence and improvements
  • Develop, drive and track project deliverables by evaluating internal and external resources while ensuring adherence to applicable regulations, guidelines and standard operating procedures
  • Ensure compliance to the company’s Quality System and external regulatory standards including ISO and FDA regulations as well as CMC requirements, including a strong understanding of the U.S. device design control process
  • Write, edit, assemble and maintain documentation for Companion Diagnostic FDA submissions; Serve as liaison between the company and the FDA in the Companion Diagnostic approval process
  • Review and/or prepare critical reports to monitoring agencies and serve as a company spokesperson to outside contacts
  • Demonstrate strong project management skills to oversee multiple projects

 

Experience and Qualifications

  • Experienced developer of companion diagnostics technologies, familiar with the entire development process as well as the regulatory requirements for both CDx and therapeutics. 
  • Will have brought CDx products from design through approval in a fast- paced biotechnology setting, ideally within a top-tier precision medicine organization.
  • Will work closely with both internal teams (early research, bioinformatics, regulatory, clinical, quality) and external consultants to bring these devices to market.

 

Additional qualifications:

  • 10 or more years of hands-on experience developing in vitro diagnostics under the current device design control regulations
  • Direct involvement in successful FDA submissions required; PMA or companion diagnostic submission experience desired
  • Fluent in the regulatory requirements for companion diagnostics and therapeutics (biologic and small molecule, ideally); able to interface productively with FDA and influence their thinking
  • Experience with genetic or molecular diagnostic tests required; startup experience preferred

 

Skills and Abilities

  • The successful candidate should be comfortable in uncharted territory, solving problems and figuring out solutions in an environment of discovery, uncertainty and innovation.
  • Proactive, highly communicative development leader who is keen to pioneer a novel scientific area and build the “precision” into the precision therapies differentiating this best-in-class immune therapies company.
  • Strong communication skills; able to build relationships and communicate complex scientific ideas to expert and lay audiences, both internally and externally
  • A hands-on, entrepreneurial style with a sense of urgency, a bias toward action, the ability to analyze situations rapidly and make prudent decisions
  • Sound strategic, clinical, technical, operational and ethical judgment with uncompromising integrity

 

 

All qualified applicants are considered for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, veteran status or other protected class.