Vice President, Clinical Development

Vice President, Clinical Development- San Diego

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 physician leader to serve as Vice President, Clinical Development who will lead a portfolio of the company’s clinical studies to include the company’s Phase II SSC-ILD program, PRA052 currently in Phase I for Ulcerative Colitis, as well as future indications that are to be selected. 

This position will play a key role in driving the execution of studies from indication selection, protocol concept, design, and conduct, to final report including interpretation of clinical data, and preparation of documents for filing with regulatory agencies.

As a subject matter expert, the incumbent will work with key stakeholders on the development of clinical protocols to support the company’s product strategy, data collection and management, and final reports development in compliance with appropriate standard operating procedures, and regulatory and medical standards. This position interacts with various groups within the company and externally to the business to ensure alignment and oversee clinical research activities.

There is an opportunity for the position to be developed to lead global product development based on a candidate’s experience and interests.

Key Duties and Responsibilities

• Provide clinical leadership of trial execution from first-in-human through registrational studies.
• 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.
• 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. Offer clinical input/direction on early-stage, pre-clinical projects.
• 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.
• Partner with Medical Affairs on the overall strategy for Target Product Profiles, clinical trial design, and ensuring dissemination of medically accurate information related to Prometheus’ product candidates.

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.

• A minimum of 10+ years of experience in pharmaceutical clinical drug development in industry including protocol development; study initiation and follow-up; IRB/EC submissions and interactions; review of clinical study data listings; review and/or preparation of clinical study reports.
• The candidate should have experience with U.S. and European Health Authority interactions and have experience with submissions of clinical regulatory documents.
• A clinical background that includes experience in inflammatory or immune-mediated diseases a plus (rheumatology, dermatology, pulmonology, etc). However, experience working across broad disease areas with an aptitude for learning equally desired.
• Exceptional execution, and implementation of practices and initiatives to ensure timelines and budgets are met.
• The ability to build and maintain excellent interpersonal relationships, both within and outside the company, at all levels.
• 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 a highly dynamic work environment and embrace uncertainty.

Skills and Abilities

• 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.