PK Scientist I

Your New Company!

At Altasciences we all move in unison to assist and work in the discovery, development, and manufacturing of new drug therapies to get them faster to people who need them. No matter your role, we all play an important part and you will have a significant impact on the health and well-being of people across the globe. By living our values of Employee Development, Customer Focus, Quality and Excellence, Respect and Integrity, we look to foster a passionate and collaborative work environment and we are looking for talented and enthusiastic people, like you, to join our growing team! Whether you’re a recent college graduate or seeking your next career opportunity, it’s time to discover your future at Altasciences.

We are better together and together We Are Altasciences.

About The Role

The PK Scientist I is responsible for gathering and synthesizing scientific information, performing PK analysis, and providing high-quality documents to support sponsors' research programs.

What You'll Do Here

• Serve as the PK representative or nonclinical principal investigator or contributing scientist on assigned project teams.
• Review of protocols for studies of moderate complexity.
• Contribute to risk assessment and management plans (RAMPs) for assigned studies.
• Prepare and/or review data transfer agreements (DTAs).
• Prepare and/or review protocol deviation impact assessments, sample inventory summaries (SIS), and PK population determinations.
• Prepare and/or review PK sections of statistical analysis plans (SAPs) for studies of simple to moderate complexity.
• Perform non-compartmental PK analysis for studies of simple to moderate complexity using Phoenix WinNonlin software.
• Perform toxicokinetic (TK) analysis and prepare nonclinical reports in accordance with project/client specifications and Good Laboratory Practice (GLP).
• Provide critical interpretation of PK results.
• Prepare and/or review of PK sections of clinical study reports (CSRs), preliminary results summaries, and standalone reports for studies of simple to moderate complexity in
  
  

accordance with project/client specifications and International Conference on Harmonisation (ICH) E3 guidance.

• Review and provide assistance in answering deficiency letters from regulatory agencies, as required.
• Perform literature searches/reviews as necessary to obtain background information for analyses and interpretation.
• Perform quality control (QC) review of analyses and documents prepared by other team members for completeness, accuracy, consistency, and structure.
• Actively participate in internal and external project team meetings, as required.
• Coordinate with internal team to deliver high-quality documents in accordance with agreed upon timelines.
• Conduct all work in compliance with standard operating procedures (SOPs), Good Clinical Practice (GCP), and all regulatory guidelines.
• Maintain familiarity with client expectations and produce analyses and documents consistent with these.
• Have awareness of regulatory guidelines of related authorities (Therapeutic Products Directorate [TPD], Food and Drug Administration [FDA], European Medicines Agency [EMA], etc) as well as ICH and GCP procedures.
• May participate in departmental or interdepartmental quality improvement initiatives.
• Maintain and participate in the objectives of the department.
  
  

What You'll Need To Succeed

• Master’s Degree in Pharmacy, Pharmacology, or relevant field (experience may be substituted for education)
• Excellent verbal and written communication skills.
• Professional attitude and strong interpersonal skills.
• Ability to acquire and apply knowledge quickly.
• Ability to work well with a multi-disciplinary team of professionals.
• Client-focused approach to work.
• Flexible attitude with respect to work assignments and new learning.
• Ability to prioritize workload.
• Understanding of clinical research, pharmacology and PK, drug development process, and applicable regulatory guidelines.
• Good computer skills (Microsoft Word, Excel, and Power Point and Phoenix WinNonlin) and ability to understand and adapt to various information technology (IT) systems.
  
  

What We Offer

• Permanent, full-time position.
• Remote position.
  
  

The pay range estimated for this position is salary range: $70000 - $90 000. Please note that hourly rates/salaries vary within the range based on factors including, but not limited to, prior relevant experience, skills, education, certification, location as well as internal equity and market data.

Altasciences offers a wide variety of benefits to help our employees live healthy and fulfilling lives both at and outside of work.

Altasciences’ Benefits Package Includes

• Health/Dental/Vision Insurance Plans
• 401(k)/RRSP with Employer Match
• Paid Vacation and Holidays
• Paid Sick and Bereavement Leave
• Employee Assistance & Telehealth Programs
  
  

Altasciences’ Incentive Programs Include

• Training & Development Programs
• Employee Referral Bonus Program
• Annual Performance Reviews
  
  

MOVING IN UNISON TO DELIVER A BIG IMPACT WITH A PERSONAL TOUCH

Altasciences is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, creed, sex, sexual orientation, gender identity, national origin, disability or any other protected grounds under applicable legislation. Reasonable accommodations for persons with disabilities during the recruitment process are available upon request. Join us at Altasciences!