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Sr. Director, Clinical Development & Medical Affairs at Prometheus Biosciences in San Diego, California

Posted in Other 30+ days ago.

Type: Full Time

Job Description:


About Prometheus Biosciences, Inc.
Prometheus Biosciences, Inc. is a privately held 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 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 guided by its 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. In addition, Prometheus has entered into collaborations to develop targeted therapies for IBD.

Responsible for overseeing the development and execution of clinical trial recruitment strategy, lead medical communication and education, and contribute to the medical strategy for target selection and development plan. This individual will also be expected to cultivate relationships with key opinion leaders and investigators, serve as an outward-facing representative of the company to the medical and scientific community.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
- Provide leadership to all aspects of medical communication and education
- Lead the recruitment effort for clinical studies
- Partner with preclinical to provide clinical perspective to target selection and development strategy
- Contribute to trial design
- Lead medical meeting preparation and presentation
- Develop publication plan
- Closely collaborate with the clinical operations team and CRO to effectively manage clinical trials and ensure the integrity of medical/scientific aspects of trial execution, analysis, and reporting
- Maintain a high level of understanding of competitive landscape in the relevant therapeutic areas
- Build and maintain solid working relationships with key opinion leaders, and lead clinical investigators. Establish and foster relationships with the international scientific and medical community.
- Attend scientific and external training meetings as needed.

This job has no supervisory responsibilities.

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.

- MD or MD/Ph.D. with gastroenterology training
- 15+ years of biopharmaceutical industry experience is required
- Subject matter expert with an exceptional command of medical literature in inflammatory bowel disease and peripheral areas
- Have demonstrated a track record of having led the recruitment in an IBD trial
- Unquestionable integrity and highest ethical standards
- Strong external presence with 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

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.

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

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.

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. The employee must occasionally lift and/or move up to 25 pounds. 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 clients, regulators, audit and conduct due diligence on API suppliers and final drug product manufacturers.

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.
While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts.
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.