Senior Director, Clinical Scientist – San Diego Preferred but will consider remote

Senior Director, Clinical Scientist – SD Preferred but will consider remote

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.   Headquartered in San Diego, Prometheus Biosciences, Inc. was named Best Places to Work by Biospace, San Diego Business Journal and is a Great Place to Work-Certified™ Company. 

Summary

Prometheus Biosciences is seeking a highly motivated hands-on Clinical Scientist who will help with the execution of the company’s clinical studies in immune-mediated diseases.  This position reports to the VP, Clinical Development and will be responsible for execution of clinical trials including regular data review, respond to site questions, review of study-related documents (e.g., informed consent forms, protocol amendments, study newsletters, etc.).  This position will also contribute to the oversight of advancing the Company’s clinical studies and will serve as one of the medical liaisons between investigators and the internal study team. 

Responsibilities

• Provide clinical expertise for trial execution from first-in-human through registrational studies.
• Conduct clinical activities focusing on data review, analysis, and reporting that conforms to the highest ethical, safety and quality standards and in compliance with GCP and regulatory standards.
• Provide clinical expertise in the preparation of Protocols, Protocol Amendments, Clinical Study Reports, Annual Reports and other safety reports, Health Authority pre-meeting packages, Investigator Brochures and other periodic clinical reports.

Experience and Qualifications

• Advanced degree such as PharmD, PhD, DVM, BSN, RN or equivalent is required
• 5 or more years of experience in clinical research or clinical science preferably within a pharmaceutical or biotech environment; experience in a contract research organization or academic institution is an acceptable alternative
• Proficient knowledge and skills to support data listing review, trend identification, data interpretation
• Familiarity with Medidata, RAVE, J-review or other clinical databases or other data review tools (patient profiles, listings) desirable but not required

Skills and Abilities

• Strong written and verbal communication skills, attention to detail, problem solving skills and flexible working hours
• A hands-on, entrepreneurial style with a sense of urgency, a bias toward action, comfort with calculated risk, and the ability to analyze situations rapidly and make prudent decisions
• Engaged, independent and goal-oriented; willingness to work in highly dynamic work environment and embrace uncertainty
• Ability to multi-task and willingness to flexibly contribute simultaneously in multiple facets of drug development; willingness to learn new therapeutic areas
• Sound strategic, clinical, technical, operational, and ethical judgment with uncompromising integrity
• Willingness to travel, depending on business needs

The anticipated base pay range for this position is $200,000 to $300,000.  Individual pay is determined by job-related skills, experience, and relevant education or training.