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.

Location: US or Canada (remote)

Summary:

The Senior Director, Clinical Pharmacology independently leads and oversees Clinical Pharmacology activities within the Clinical Pharmacology, Modeling, and Simulation area. Senior Director, Clinical Pharmacology is a member of the Clinical Pharmacology Director\xe2\x80\x99s team.

Responsibilities:

• Independently lead and oversee development of strategic advice to clients on clinical pharmacology and overall drug development activities as part of a cross functional team
• Independently lead and oversee the design, analysis, and interpretation of clinical pharmacology studies (renal, hepatic, TQT, ADME, DDI, BE/BA, SAD, MAD, etc.) and provide guidance to optimize pharmacokinetic sampling and dosing strategies
• Critically evaluate technical and scientific aspects of PK and PK/PD projects/programs for clients
• Familiarity with noncompartmental analysis and population PK/PBPK/QSP modeling
• Independently lead and oversee development of statistical and PK analysis plans, standalone PK/PD reports, and PK/PD CSR sections
• Independently lead and oversee the preparation and review of clinical protocols, clinical study reports, clinical pharmacology strategic plans, INDs, clinical pharmacology and safety sections of NDAs, Investigator Brochures, FDA briefing packets, and other clinical and regulatory documents
• Maintain up-to-date training on cGLP regulations, appropriate company SOPs, and relevant PK and clinical pharmacology guidance
• Contribute to development of best practices and standard operating procedures for clinical pharmacology

Requirements

• Ph.D.
• 10+ years of relevant work experience

• Strong written and verbal communication skills, including good command of English language
• Client focused
• Ability to work in a fast-paced environment
• Proficiency with various computer applications and PK analysis software

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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