Director Group Quantitative Pharmacology

About the role

This individual is accountable for the delivery of support for one or more research & development programs, within their pharmacometrics discipline. They manage and are accountable for the PK/PD evaluation of a small portfolio of products or projects, inform PMx management of important program and regulatory developments, ensure analyses and documentation are of the highest quality and accuracy, and ensure reports and other documents have the appropriate messaging and a meaningful "story-line".

Responsibilities

• Manages and is accountable for the PK/PD evaluation of a small portfolio of products or projects.
• Works independently, with guidance in only the most complex situations.
• Informs PMx management of important program and regulatory developments in a timely manner.
• Ensures analyses and documentation are of the highest quality and accuracy.
• Solves complex problems; takes a broad perspective to identify solutions.
• Makes contributions to multi-disciplinary meetings by sharing cross-functional skills and knowledge.
• Has excellent interpersonal and communication skills, both written and oral, and has ability to communicate complex information succinctly.

Requirements

• Fully knowledgeable of pharmacokinetic /pharmacodynamic principles, pharmacology, biology, and quantitative aspects of drug development as well as having an advanced knowledge of pharmaceutical drug development.
• Deep understanding of scientific literature and technical skills in a number of PK/PD methods and techniques.
• Extensive knowledge base of the work in overall scientific community in own discipline.
• Recognized as an expert in own area within the organization.
• Extensive regulatory experience through authoring of regulatory briefing books, CTD summaries, contribution at HA meetings, HA negotiations through regulatory reviews and approvals of BLA or equivalent.

Qualifications

• PhD in Quantitative Pharmacology (Pharmacometrics) or related field.
• Hands on usage of a broad range of quantitative tools and systems.
• Strong publication record in the field.
• Proven track record of displaying excellent interpersonal and communication skills both written and oral and ability to communicate complex information succinctly.
• Proven experience developing QP elements of regulatory strategy and interacting with regulatory agencies without supervision.

Skills

• Knowledge of pharmacokinetic /pharmacodynamic principles, pharmacology, biology, and quantitative aspects of drug development.
• Advanced knowledge of pharmaceutical drug development.
• Technical skills in a number of PK/PD methods and techniques.
• Strong publication record in the field.
• Excellent interpersonal and communication skills, both written and oral.
• Experience developing QP elements of regulatory strategy and interacting with regulatory agencies without supervision.

Benefits

• Annual bonuses or other incentive plans.
• Equity awards.
• Pension or retirement benefits.
• 401(k) company match.
• Health and wellness programs.
• Fitness centers.
• Insurance benefits (e.g. medical, dental, vision, life and disability).
• Paid time off.
• Family support benefits.

Pay

$205,000.00 - $341,600.00 annually

Schedule

Full-time