Director Quantitative Pharmacologist

BioSpace; Village of Tarrytown (NY); On-site; USD 120,000 - 160,000; Full time

Job summary

A leading pharmaceutical company in New York is seeking a Director in Pharmacometrics to manage quantitative analyses for R&D programs. The successful candidate will have a PhD with over 8 years of experience, regulatory expertise, and a proven publication record. This role offers the opportunity to influence critical drug development strategies and ensure high-quality results in a scientific environment.

Qualifications

• 8+ years of experience in Quantitative Pharmacology or related field.
• Expertise in regulatory processes and drug development.
• Strong publication record and ability to communicate complex information.

Responsibilities

• Manage PK/PD evaluations for a portfolio of products.
• Deliver high-quality analyses and documentation.
• Inform management of program developments in a timely manner.

Skills

Quantitative Pharmacology

Pharmacokinetic/Pharmacodynamic Principles

Regulatory Experience

Interpersonal Skills

Education

PhD in Quantitative Pharmacology or related field

Tools

Quantitative Tools and Systems

Job description

Overview

As a Director in Pharmacometrics (Quantitative Pharmacology), this role is accountable for delivering support for one or more research & development programs within the pharmacometrics discipline, including timely and accurate quantitative analyses, interpretation, and messaging to PMx management, and the delivery of well-constructed reports for PMx review.

Responsibilities

• Manage and be accountable for the PK/PD evaluation of a small portfolio of products or projects.
• Work independently, with guidance only in the most complex situations.
• Inform PMx management of important program and regulatory developments in a timely manner.
• Ensure analyses and documentation are of the highest quality and accuracy.
• Ensure that reports and other documents have appropriate messaging and that a meaningful storyline is developed.
• Ensure study reports and other documents have an appropriate functional review and are suitable for review by senior management.
• Solve complex problems and take a broad perspective to identify solutions.
• Maintain a strong publication record and actively publish work in scientific literature.
• Contribute to multi-disciplinary meetings by sharing cross-functional skills and knowledge.
• Demonstrate excellent interpersonal and communication skills, both written and oral, with the ability to communicate complex information succinctly.

Qualifications

• PhD with 8+ years of experience in Quantitative Pharmacology (pharmacometrics) or a related field.
• Fully knowledgeable of pharmacokinetic/pharmacodynamic principles, pharmacology, biology, and quantitative aspects of drug development, with advanced knowledge of pharmaceutical drug development.
• Deep understanding of scientific literature and technical skills in multiple PK/PD methods; extensive knowledge of work in the broader scientific community within the discipline.
• Recognition as an expert in the area within the organization.
• Extensive regulatory experience, including authoring regulatory briefing books, CTD summaries, contributions at HA meetings, and negotiations through regulatory reviews and approvals of BLA or equivalent.
• Decision-making guided by policies, procedures, and business plans; receives guidance from head of function.
• Hands-on experience with a broad range of quantitative tools and systems; strong publication record in the field.
• Proven experience developing QP elements of regulatory strategy and interacting with regulatory agencies without supervision.

Additional notes: Roles may include related responsibilities as defined by the organization. Salary ranges and location details are provided per applicable laws and regulations and may vary by locale.