Clinical Pharmacologist

About USDM

USDM Life Sciences is a premier consulting company with 20+ years of experience assisting heavily regulated biotech, medical device, and pharmaceutical companies with their GxP technologies to accelerate growth. Our deep domain knowledge and technology expertise in life sciences business processes are what set us apart. From strategy to implementation and adoption, we have delivered thousands of GxP projects globally.

As part of the USDM team, you have the opportunity to work with cutting-edge technologies through our many partnerships with companies like Microsoft, Google, Oracle, DocuSign, Box, and many more. From molecule to market, you will help connect technology, people, and data in new ways to generate real-time insights to improve business outcomes for USDM’s clients. Are you ready to make an impact and drive real digital transformation in life sciences?

Founded in Santa Barbara in 1999, USDM has grown to a progressive, global company with 300+ remote employees and offices throughout the US, Canada, and Germany.

Nature and Scope of Job

Clinical Pharmacology, Director will support the PK/PD aspects of clinical studies (from protocol to CSR) and related regulatory submission activities. This role requires a strong pharmacokinetics/pharmacodynamics/pharmacometrics knowledge.

Primary Responsibilities

• Support PK/PD aspects of clinical studies, including synopsis/protocol development, statistical analysis plan and clinical pharmacology data analysis plan review, TLF shell and dry-run reviews, and CSR.
• Oversee relevant PK/PD data analyses: non-compartmental PK, population PK and PK/PD, and other modeling and simulation activities as needed.
• Contribute to regulatory documents including Investigator Brochures, Labeling and those required for regulatory meetings and regulatory filings.
  
  

Additional Responsibilities

• Performs other related duties and assignments as required
  
  

Qualifications

• Educational background in clinical pharmacology, biopharmaceutics, pharmaceutical sciences, biomedical engineering, statistics or a related field.
• Excellent verbal and written communication skills
• Detail-oriented skills
  
  

Education & Certifications

• A Ph.D. or equivalent degree with at least 5 years of experience OR an MS or equivalent degree with at least 10 years of experience, where experience means having a proven track record within the duties mentioned above in pharmaceutical industry, regulatory agency, or academia.
  
  

Working Conditions

The working conditions described here are representative of those that must be met by an employee to successfully perform the essential responsibilities and functions of the job and are not meant to be all-inclusive. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential responsibilities and functions of the job.

Unless reasonable accommodations can be made, while performing this job the staff member shall:

• Prolonged periods of sitting or standing at a desk and working on a computer in an environmentally controlled home office environment.
• Operate other office productivity machinery, such as a calculator, scanner, or printer.
• Frequently communicate with stakeholders via telephone, email, or instant message. Must be able to exchange accurate information in these situations.
  
  

Equal Opportunity Statement

USDM Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Disclaimer

This job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. USDM Life Sciences reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

Compensation

Salary/Hourly Rate Range (W2): USD $270 - $280

The base salary/hourly rate range represents the anticipated low and high end of the USDM’s compensation range for this position. Actual salaries/hourly rates will vary and will be based on various factors, such as the candidate’s qualifications, skills, competencies, and proficiency for the role. The compensation described above is subject to change and could be higher or lower than the range described based on market survey data or budget.

Full-time employees are eligible for health, vision, and dental insurance, life insurance, short and long-term disability, hospital indemnity, accident, and critical care coverage.

Both full and part-time employees, who are at least 21 years of age, are eligible to participate in USDM's 401k plan. Full and part-time employees may be eligible for paid time off.

All employees are eligible for USDM's rewards and recognition program.

For more details about our benefits, visit us here: https://usdm.com/careers " href=" https://usdm.com/careers " target="_blank"> https://usdm.com/careers