Senior Medical Director, Clinical Development - 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.
Prometheus Biosciences is seeking a highly motivated hands-on physician leader to serve as Senior Medical Director in Clinical Development who will drive the clinical design, execution, and interpretation of the company’s clinical studies in immune-mediated diseases within a therapeutic area or indication.
This position will be responsible for the oversight of advancing the company’s clinical studies. The candidate will be the primary source of medical accountability and oversight for clinical trial(s) in respective therapeutic area and will serve as a medical lead. The candidate will liaise 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 in immune -mediated disease and with drug development experience preferred.
Key Duties and Responsibilities
- Medical strategic oversight and accountable for the formulation of study designs, protocol development, and regulatory documents in collaboration with cross-functional team
- Provide clinical leadership of trial execution and manages from first-in-human through registrational studies. Provide clinical leadership in the conduct of clinical activities including executional delivery of the study, recruitment, site activation, 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, including regulatory 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, to provide input and guidance for the strategic direction of Prometheus Biosciences’ programs
- Keeps abreast of development and regulatory issues related to competitive compounds in development and how our program(s) or portfolio fits into the competitive landscape
- Attend and present at investigator meetings and site initiation visits as applicable
- Provide clinical leadership and contribute to the preparation of protocols, 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/DO degree or equivalent is required
- Board Certification or Board Eligibility in internal medicine, subspecialty training or experience in drug development in applicable therapeutic area 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 may be 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