Clinical Trial Assistant

Clinical Development San Diego, California


Description

COMPANY DESCRIPTION

  • IPO, clinical stage biotech with lead asset in Ph 1 and potential for first-in-class mechanism
  • First precision medicine approach to GI therapeutics, with platform attracting strong partners
  • Global exclusive license to Cedars-Sinai’s GI biobank and bioinformatics platform
  • Fully capitalized with top-tier investor syndicate

 

Prometheus is a IPO biotechnology company pioneering a precision medicine approach to the discovery, development, and commercialization of novel therapeutic and companion diagnostic products for the treatment and diagnosis of inflammatory bowel disease (IBD). The company's precision medicine platform, Prometheus 360, combines proprietary bioinformatics discovery methods with one of the world's largest gastrointestinal bioinformatics databases to identify novel therapeutic targets and develop therapeutic candidates to engage those targets. Prometheus is a spin out of Cedars-Sinai Medical Center and partners with the hospital system for its biospecimens, clinical data, and bioinformatics.

 

The company is led by an exceptional management team bringing deep experience in GI and autoimmune therapies. CEO Mark McKenna joined in 2019 to refocus the organization around a precision therapeutics strategy after orchestrating a successful turnaround effort at Salix Pharmaceuticals. Mark and the executive team are guided by Prometheus’ board of directors, led by Chairman Tachi Yamada, M.D., and a scientific advisory board composed of key opinion leaders in IBD, including Stephan Targan, M.D., William Sandborn, M.D. and Dermot P. McGovern, M.D., Ph.D.

 

The company recently secured a $130 million Series D financing with a top-tier syndicate and is attracting best-in-class collaboration partners such as Takeda and Dr. Falk. With a lead therapeutic program in Phase 1 studies and a robust emerging pipeline, the company is seeking a best-in-class immunologist to lead all of Prometheus’ preclinical development efforts and be accountable for delivering a sustainable pipeline of drug candidates, from target validation through IND submission.


SUMMARY

Responsible for providing administrative support for all Prometheus sponsored clinical trials.  Under the direction of the Sr. Director, Clinical Operations or designee, this position will serve as the primary administrative support for the clinical study team. 

ESSENTIAL DUTIES AND RESPONSIBILITIES

  • Prepare, handle, distribute, file (paper and electronic), and archive clinical documentation and reports.
  • Review of study files periodically for accuracy and completeness.
  • Implement company policies and procedures for assigned functions.
  • Initiate clinical trial supportive tasks in a pro-active manner to accomplish company objectives.
  • Assist with study vendor and site payment tracking.
  • Provide operational support for clinical trials (e.g., organize study information, maintain tracking lists, ship clinical trial materials).
  • May act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.
  • Perform administrative tasks to support team members with clinical trial execution as needed.
  • Other tasks as assigned.

 
QUALIFICATIONS 

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION and/or EXPERIENCE

  • BA, BS, RN, BSN or equivalent
  • Basic knowledge and adherence to GCPs
  • Strong attention to detail
  • Ability to multi-task
  • Minimum of 2 years experience in biopharmaceutical industry
  • Unquestionable integrity and highest ethical standards
  • Excellent written and verbal communication skills
  • Self-motivated, assertive, and driven


PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is frequently required to sit and talk or hear.  The employee is occasionally required to stand, walk, use hands and/or  fingers to grasp handle, or feel; and reach with hands and arms.  Specific vision abilities required by this job include close vision, distance vision, and ability to adjust focus.

Minimal amount of travel is expected of this job; may require travel to meet with vendors.


WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The noise level in the work environment is usually quiet.

Travel up to 10% may be required.


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.