Job Description

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.

Summary:

The Director/Senior Director, Pharmacometrics is responsible for providing strategy and leadership to the Pharmacometrics team within the Clinical Pharmacology, Modeling and Simulation (CPMS) area. Responsibilities include directing or conducting modeling and simulation analyses, providing strategic advice to clients, collaborating with and mentoring other pharmacometricians, and representing clients at meetings with regulatory agencies.

The Director/Senior Director works directly with the CPMS leadership.

Location: Canada (Remote)

Responsibilities:

• Direct and/or conduct population PK analysis using appropriate software
• Develop novel population PK analysis approaches the increase the efficiency and accuracy of population PK analysis
• Assist in the 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
• Provide strategic advice to clients, develop clinical pharmacology strategic plans, and take ownership/responsibility for client deliverables
• Work with other consultants to prepare and review PK reports and other clinical pharmacology documents
• Author clinical pharmacology and pharmacokinetic sections of regulatory documents, including INDs, NDAs, briefing packets, Investigator Brochures, etc.
• Represent clients at meetings with US and ex-US regulatory agencies
• Support client\xe2\x80\x99s nonclinical efforts to ensure that sufficient preclinical PK data exists to design and execute clinical studies
• Maintain current knowledge of advancements in PK and PK/PD science, regulatory guidance documents, FDA rulings, internal SOPs, and internal company guidances to be able to contribute ideas to improve technologies and procedures for PK practices
• Support business development and marketing activities, foster client relationships, and bring new clients into the consulting firm
• Maintain up-to-date training on appropriate company SOP\'s and guidances

• Actively contribute to staff learning & development within the company

• Review, evaluate, and approve processes and procedures for the pharmacometrics division within the Quality Management System as required

• Monitor and assure client satisfaction on existing projects for the pharmacometrics division with related activities
• Identify key accounts and maintain strong long-lasting relationships to win new and repeat business

• Contribute to other areas of business as required

• Life science, healthcare and/or business degree
• Minimum 8-10 years of relevant work experience, including experience in drug development, clinical pharmacology, and pharmacometrics
• Proficiency in NONMEM, Pirana, and R software preferred
• Strong analytical 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, and PowerPoint required
• Strong leadership skills
• Effective at problem solving, strategic thinking, and conflict resolution
• Strong presentation and networking capabilities
• Excellent organizational, negotiating, and financial skills

Allucent