PK Scientist I

🔥 3 minutes ago

🌐 Canada, United States – Remote

🇨🇦 Canada – Remote 🇺🇸 United States – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

👻 Ghost score 10%

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Altasciences

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1998

🏥 Healthcare

💼 Consulting

📦 Logistics

💰 Private Equity Round on 2017-06

Healthcare • Consulting • Logistics

Altasciences is a forward-thinking, mid-size early phase contract research organization located in Canada and the U. S. , catering to biopharmaceutical companies of all sizes. The company specializes in offering a flexible approach to early drug development, with services that include preclinical safety testing, clinical pharmacology from Phase I to Phase II, bioanalysis from preclinical to Phase IV, as well as research and manufacturing analytical services. Altasciences is committed to accelerating early-phase drug development, ensuring seamless transitions from lead candidate selection to proof of concept and beyond, thereby delivering impactful results with a personal touch.

📋 Description

• Gather and synthesize scientific information • Perform PK analysis and provide high-quality documents supporting sponsors' research programs • Serve as the PK representative, nonclinical principal investigator, or contributing scientist on assigned project teams • Review protocols for studies of moderate complexity • Prepare or review data transfer agreements, protocol deviation impact assessments, sample inventory summaries, and PK population determinations • Prepare or review PK sections of statistical analysis plans • Perform non-compartmental PK analysis using Phoenix WinNonlin • Perform toxicokinetic analysis and prepare nonclinical reports in accordance with project/client specifications and GLP • Interpret PK results • Prepare or review PK sections of clinical study reports, preliminary results summaries, and standalone reports in accordance with ICH E3 guidance • Review and assist with responses to regulatory-agency deficiency letters • Conduct literature searches and reviews • Perform quality-control reviews of analyses and documents • Participate in internal and external project-team meetings • Coordinate with internal teams to deliver documents within agreed timelines • Contribute to risk assessment and management plans • Conduct work in compliance with SOPs, GCP, and regulatory guidelines • Maintain familiarity with client expectations and produce consistent analyses and documents • Participate in quality-improvement initiatives and departmental objectives

🎯 Requirements

• Bachelor’s Degree in Pharmacy, Pharmacology, or relevant field (experience may be substituted for education) • Minimum of 2 years experience as PK • Experience in a non clinical TK setting an asset • Experience with Phoenix WinNonlin • 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 ability to understand and adapt to various information technology (IT) systems • Fluency in English is an essential requirement for the position

🏖️ Benefits

• Health/dental/vision insurance plans • RRSP with employer match • Paid vacation and statutory vacations • Paid sick leave and bereavement leave • Employee assistance and telehealth programs • Training and development programs • Employee orientation bonus program • Annual performance reviews

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