Principal Scientist, Clinical Pharmacokinetic

Job Description

Job Description

SITUATION

Prometheus Laboratories is a forward-thinking clinical diagnostics company that is dedicated to disrupting the treatment paradigm of GI and autoimmune diseases.

We do this by discovering and developing a broad portfolio of novel, precision-based diagnostic testing solutions that meaningfully impact patient care throughout their individual healthcare journey.

From patient-personalized diagnosis and prognosis, disease profiling, therapeutic selection through disease monitoring, the Prometheus suite of tests is purpose-built to take the guess work out of critical patient care needs.

Our ambition is to expand our team with like-minded leaders with shared passion and dedication for transforming the future of precision-guided patient care.

SUMMARY

Prometheus is developing a state-of-the-art precision guided dosing solution for the management of immune mediated inflammatory bowel disease across gastrointestinal, rheumatological, dermatological and neurological segments.

The incumbent will be responsible for creating, developing, validating and transferring precision guided scientific plan and testing solutions to the clinical laboratory setting to improve the outcome of patients suffering from autoimmune disease.

The incumbent will also be responsible to produce a solid academic peer reviewed publication plan to support the evidence development plan, clinical validity and utility of the precision guided solutions while also developing an intellectual property portfolio to protect discoveries and inventions.

Ideally the candidate for that position is also eligible to take duties in the clinical PK section of the clinical laboratory, and has a proven track record of excellence in publishing in peer reviewed scientific journals.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties as assigned.

• Responsible for diverse problem solving in the areas of clinical pharmacokinetics and dynamics and in autoimmune disorders with a large focus on inflammatory bowel disease.
• Interacts scientifically with world class pharmaceutical companies to develop diagnostics strategies and precision guided dosing tools for disease management and dosing optimization.
• Detects / identifies best current and new therapeutic / diagnostic precision guided strategy on an individualized patient basis current patient database mining and any other methods to improve diagnostic results.
• Communicates effectively with clinicians and scientists to address current and future clinical best practice concerns and technical needs with possible therapeutic and diagnostic solutions.
• Communicates and consults with management on new discoveries and technologies to aid in establishing the long-range technical strategies for best diagnostic approaches to improve personalized medicine therapeutic opportunities.
• Writes or advises on the development of patents and intellectual property.
• Considered technical expert by peers, subordinates and management and is recognized as the go to person to answer difficult questions and issues concerning our current and future clinical diagnostic products and technology.
• Attends scientific meetings and presents new and innovative technical developments to promote companies capabilities.
• Develops a reputation in the medical and scientific community as a national expert in technologies and methods developed and practiced by the company.
• Publishes in peer reviewed journals technologies and methods recognized as significant achievements in medical and scientist communities associated in the companies areas of interest.

SUPERVISORY RESPONSIBILITIES

May supervise employees within the clinical pharmacokinetic Research and Development department either directly or via matrix management .

Carry out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring, and some training of employees;

planning, assigning, and directing work, appraising performance; rewarding and disciplining performance; addressing complaints and resolving problems.

QUALIFICATIONS

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.

EDUCATION and / or EXPERIENCE

The successful candidate will requires a PharmD, PhD degree with 5+ years postdoctoral experience in clinical pharmacokinetic and 5+ years of managerial / leadership experience required.

Junior candidates will be considered with the right spirit and can-do attitude. Deep understanding and expertise in basic and applied clinical pharmacokinetics to identify and stratify specific precision guided dosing and therapeutic selection is essential.

Has leadership and collaboration skills to build strong relationships, both internally and externally. Demonstrated ability to drive technical needs to ensure strategy alignment from the top through the organization as required.

Nationally recognized within the fields of interest such as personalized medicine and diagnostic methods to indicate therapeutic selection through peer reviewed publications, patent, meetings and / or work strongly preferred.

LANGUAGE SKILLS

Ability to reads, analyzes, and interprets highly complex documents. Ability to respond effectively to sensitive inquiries or issues with key opinion leaders in a field of interest.

Ability to write speeches and articles and peer reviewed publications using accepted or innovative techniques or style. Ability to deliver effective and persuasive presentations on complex topics to top management and at outside venues.

MATHEMATICAL SKILLS

Ability to apply advanced mathematical concepts such as exponents, logarithms, algorithms, quadratic equations, and permutations.

Deep expertise in population PK is essential for that position (e.g. NONMEM, Monolix). Expertise with coding in R a plus.

Ability to perform data management and population PK analysis with covariate and Bayesian priorsAbility to operate personal computer and perform complex word processing and data handling programs including bioinformatics and complex statistical analysis such as algorithms.

REASONING ABILITY

Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems. Ability to deal with nonverbal symbolism (formulas, scientific equations, graphs, etc.

in its most difficult phases. Ability to deal with a variety of abstract and concrete variables. Works on abstract problems across functional areas of the business and has the ability to communicate high level technical findings.

CERTIFICATES, LICENSES, REGISTRATIONS

None required but eligibility for California licensure a plus.

PHYSICAL DEMANDS

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 regularly required to sit. The employee frequently is required to use hands to finger, handle, or feel;

reach with hands and arms; and talk or hear. The employee is occasionally required to stand and walk. The employee must occasionally lift and / or move up to 25 pounds.

Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.

WORK ENVIRONMENT

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, fumes or airborne particles, toxic or caustic chemicals, and extreme cold.

The noise level in the work environment is moderate with background sounds from instruments and freezers.

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.