Medical Director, Clinical Development

Clinical Development San Diego, California


Description

Medical Director, Clinical Development - San Diego, California

 

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, starting first with inflammatory bowel disease (IBD).

The Company’s precision medicine platform, Prometheus360™, 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 headquartered in San Diego, CA.

Summary

Prometheus Biosciences is seeking a highly motivated hands-on physician leader to serve as Medical Director in Clinical Development who will lead the execution of the company’s clinical studies in immune-mediated diseases.

This position will be responsible for the oversight of advancing the company’s clinical studies, will serve as a medical liaison between investigators and the internal study team, and will maintain established relationships with key opinion leaders as well as Health Authorities.  The ideal candidate should be trained in internal medicine with subspecialty training or drug development experience in GI, rheumatology or pulmonary medicine preferred. 

Key Duties and Responsibilities

  • Provide clinical leadership of trial execution from first-in-human through registrational studies
  • Contribute to the formulation of study designs, protocol development, regulatory documents in collaboration with cross-functional teams
  • Provide clinical leadership in the conduct of clinical activities including recruitment, data review, analysis, and reporting that conforms to the highest ethical, safety and quality standards and in compliance with GCP and regulatory standards
  • Remain current on the therapeutic landscape in the relevant therapeutic areas through review of the scientific literature, interactions with key opinion leaders and other external experts and attendance at relevant scientific meetings, in order to provide input and guidance for the strategic direction of Prometheus Biosciences’ programs
  • Attend and present at investigator meetings and site initiation visits as applicable
  • Provide clinical leadership in the preparation of Clinical Study Reports, Annual Reports and other safety reports, Health Authority pre-meeting packages, Investigator Brochures and other periodic clinical reports
  • Collaborating with cross-functional groups to provide input in publication strategy including active participation in authoring, preparation and review of manuscripts, conference abstracts and presentations and other external presentations of clinical data
  • Partner with R&D to provide clinical perspective to target selection and development strategy

Education and Experience

  • MD degree or equivalent is required
  • Board Certification or Board Eligibility in internal medicine, subspecialty training or experience in drug development in gastroenterology, rheumatology, immunology, or pulmonary medicine is highly desirable
  • 4+ years of experience in clinical research including the design and execution of clinical trials, preferably within a pharmaceutical or biotech environment; experience in a contract research organization or academic institution is acceptable
  • Experience with U.S. and European Health Authority interactions and submission of clinical regulatory documents is desirable

Skills and Abilities

  • Strong written and verbal communication skills; willingness to engage with investigators, key opinion leaders, external advisors, and regulatory authorities; and ability to effectively give presentations at conferences, advisory meetings and other public forums
  • Willingness to educate and mentor internal and external colleagues and collaborators
  • 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, hands-on, independent and goal-oriented mentality; 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
  • Self-motivated; strong commitment to follow up on tasks and action items; organizational, analytical, and problem-solving skills; risk identification and management; creative and innovative thinking all highly desirable
  • Strong ability to work within and lead and motivate a cross-functional matrixed team
  • The requisite scientific acumen and communication skills to influence and collaborate with key scientific, regulatory, and business leaders
  • 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.