CATO SMS and Pharm-Olam, LLC have merged to form Allucent!

Allucent is a full-service contract research and development organization with international resources dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in order to bring new drugs, biologics, and medical devices to the people who need them. Allucent is a non-laboratory environment. At Allucent, our mission is to help bring new therapies to light. When you work at Allucent, that means rolling up your sleeves and applying your scientific knowledge, clinical expertise, and experience to partnerships with our clients in small and mid-sized biotech companies.

These customers have new therapeutic ideas but want a partner who can assist with the clinical trial process, the complexities of certain disease states, or other critical capacities. You’ll work with them on the newest treatment breakthroughs for some of the most perplexing conditions. And ultimately, you’ll help make a positive difference in patients’ lives.

Summary:

We are currently recruiting for a Pharmacokineticist II to join our team. The Pharmacokineticist II (PHARCOK2) is responsible for directing and/or conducting and reporting pharmacokinetic portions of nonclinical and clinical studies within the CPMS group of Allucent. The PHARCOK2is a member of the Pharmacokinetics Director team. The Pharmacokineticist II will serve on project teams in various capacities, including, but not limited to: PK Analyst, Quality Control reviewer, and Author. The successful candidate will possess an understanding of clinical PK and PK/PD concepts and applications.

Responsibilities:

• Direct and/or conduct noncompartmental and compartmental pharmacokinetic analysis using Phoenix® WinNonlin®.
• Design, analyze, and interpret clinical pharmacology studies (renal, hepatic, TQT, ADME, DDI, BE/BA, SAD, MAD, etc.) and provide guidance to optimize pharmacokinetic sampling and dosing strategies.
• Contribute to or conduct PK and PK-PD analyses, compartmental or population PK modeling and simulation (if needed but experience not required for the position).
• Take ownership/responsibility for client deliverables.
• Work with others to prepare and review PK reports and other clinical pharmacology documents.
• Author and Quality Control review clinical pharmacology and pharmacokinetic reports, pharmacokinetic sections of Clinical Study Reports and regulatory documents, including INDs, NDAs, Briefing Packets, Investigator Brochures, etc.
• Maintain current knowledge of advancements in PK and PK/PD science, regulatory guidance documents, FDA rulings, internal SOPs, and internal guidance to be able to contribute ideas to improve technologies and procedures for PK practices.
• Promote a culture of scientific and technical excellence.
• Mentor junior level pharmacokineticists
• Contribute to development of best-practices and standard operating procedures for clinical and preclinical kinetic analyses.
• Maintain up-to-date training on GLP regulations, appropriate company SOPs and guidance.
• Contribute to the implementation of the business strategy for the PK group within CPMS
• Contribute to operating procedures / business processes
• Collaborate and ensure open communication with other areas
• Ensure activities meet and integrate with organizational requirements for quality management, health and safety, legal stipulations, environmental policies and general duty of care

Requirements

Qualifications:

• Life science, healthcare and/or business degree
• Minimum 2yearsof relevant work experience
• Minimum 2yearsof experience in drug development and/or clinical research
• Thorough knowledge of GxP, GDPR/HIPAA, CFR and applicable (local) regulatory requirements
• Experienced in Phoenix and R software
• Strong communication skills with proficiency in Word
• Strong analytical skills

Skills:

• Strong written and verbal communication skills including good command of English language
• Representative, outgoing and client focused
• Ability to work in a fast-paced challenging environment of a growing company
• Administrative excellence
• Proficiency with various computer applications such as Word, Excel, Phoenix WinNonlin, and PowerPoint required
• Strong leadership skills
• Effective at problem solving, strategic thinking and conflict resolution
• Strong presentation and networking capabilities
• Excellent organizational skills

Benefits

• Comprehensive benefits package
• Competitive salaries per location
• Departmental Study/Training Budget for furthering professional development
• Flexible Working hours (within reason)
• Opportunity for fully remote working or Hybrid Working Model

• Leadership and mentoring opportunities
• Internal growth opportunities and career progression
• More task variety
• Financially rewarding internal employee referral program
• Access to online soft-skills and technical training via GoodHabitz and internal platforms

To all recruitment agencies: Allucent does not accept agency resumes. Please do not forward resumes to our careers alias or other Allucent employees. Allucent is not responsible for any fees related to unsolicited resumes

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