Senior Director, Clinical Operations

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 executing the clinical development strategy to ensure that all clinical development activities within the company are conducted efficiently to agreed corporate timelines and in compliance with local and global requirements.

 

ESSENTIAL DUTIES AND RESPONSIBILITIES

  • Implement clinical development plans in order to meet corporate goals and objectives.
  • Work with other departments and functions to implement clinical trial protocols.
  • Participate and assist in design and preparation of protocols and case report forms.
  • Generate clinical SOPs, policies, charters, and plans according to US and international guidelines.
  • Evaluate potential clinical CROs and sites according to established criteria of acceptability.
  • Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions.
  • Supervise and oversee contract research organizations, clinical vendors, and consultants
  • Supervise and manage activities of clinical operations personnel.
  • Prepare clinical documents for regulatory submissions.
  • Attend scientific and external training meetings as needed.
  • Willingness to travel (up to 25%)

SUPERVISORY RESPONSIBILITIES

This job will supervise clinical staff, including but not limited to, CRAs and CTAs

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
  • Thorough knowledge and adherence to GCPs
  • Strong attention to detail
  • Ability to multi-task
  • Minimum of 10 years experience in study management
  • Prior experience in conducting international studies preferred
  • Unquestionable integrity and highest ethical standards
  • Excellent written and verbal communication skills
  • Self-motivated, assertive, driven, and hands-on leader
  • Ability to operate collaboratively with colleagues across functional areas in an entrepreneurial and science-driven environment
  • Ability to forge solid personal and professional relationships with key opinion leaders and investigators


LANGUAGE SKILLS

Ability to read, analyze, and interpret common scientific and technical journals and related documents. Ability to effectively respond verbally and/or in writing to technical inquires from clinical investigators, customers, sales force, or internal person on topics related to Prometheus products.  Ability to effectively prepare and present technical information/data for internal venues or at scientific meetings. Ability to write and submit final manuscripts for publication in peer-reviewed journals, and technical documents for regulatory submission.


MATHEMATICAL SKILLS

Ability to apply moderate to advanced mathematical concepts to clinical and research data analysis such as p values, regression analysis, analysis of variance, etc.

REASONING ABILITY

Ability to define the key issues or problems, to collect information and data for problem solving, and to recommend an effective approach to problem solving and project completion. Ability to understand and use abstract and concrete variables and concepts.

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 to finger, 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.

Certain amount of travel is expected of this job, to meet with vendors, regulators, and audits.


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 25% 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.