Director Quantitative Pharmacologist

Regeneron Pharmaceuticals; Cambridge (MA); On-site; USD 202,000 - 337,000; Full time

Job summary

A leading pharmaceutical company in Cambridge is seeking a Director in Pharmacometrics to oversee quantitative analyses and regulatory interactions. The ideal candidate will have a PhD and a deep understanding of pharmacokinetics, along with at least 8 years of experience in the field. Strong communication skills and a proven track record in regulatory strategy are essential. This role offers a competitive salary range of $202,000 to $336,600 annually.

Qualifications

• 8+ years of experience in pharmacometrics or related area.
• Strong publication record in the field.
• Deep understanding of scientific literature.

Responsibilities

• Accountable for quantitative analyses and reports.
• Manage PK/PD evaluations for a portfolio of products.
• Inform management on program and regulatory developments.

Skills

Pharmacokinetic/pharmacodynamic principles

Quantitative analysis

Regulatory experience

Strong communication 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 individual is accountable for the delivery of support for one or more research & development programs within their pharmacometrics discipline. The Director is responsible for the timely and accurate delivery of quantitative analyses, interpretation, and messaging to PMx management, as well as the timely delivery of well-constructed and well-messaged reports for PMx review.

A day in the life of a Director

• 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.
• Ensures that reports and other documents have the appropriate messaging and that a meaningful “story-line” is developed.
• Ensures that study reports and other documents have an appropriate functional review and are suitable for review by senior management.
• Solves complex problems; takes a broad perspective to identify solutions.
• Has a strong publication record and actively publishes work in scientific literature.
• Contributes to multi-disciplinary meetings by sharing cross-functional skills and knowledge.
• Has excellent interpersonal and communication skills, both written and oral, and can communicate complex information succinctly.

This may be the right role for you if you

• Are fully knowledgeable of pharmacokinetic/pharmacodynamic principles, pharmacology, biology, and quantitative aspects of drug development, with advanced knowledge of pharmaceutical drug development.
• Possess a deep understanding of scientific literature and technical skills in a number of PK/PD methods and techniques; extensive knowledge of work in the scientific community in the discipline.
• Are recognized as an expert in your area within the organization.
• Have extensive regulatory experience through authoring regulatory briefing books, CTD summaries, contributions at HA meetings, HA negotiations, and regulatory reviews and approvals of a BLA or equivalent.
• Decision-making is guided by policies, procedures and the business plan; able to receive guidance from head of function.

In order to be considered qualified for this role, you must have a PhD + 8 years with a degree in Quantitative Pharmacology (pharmacometrics) or related field.

• Hands-on usage of a broad range of quantitative tools and systems is required, as is a strong publication record in the field.
• A proven track record of excellent interpersonal and communication skills, both written and oral, and the ability to communicate complex information succinctly.
• Proven experience developing QP elements of regulatory strategy and interacting with regulatory agencies without supervision.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of any protected status, sexual orientation, disability, genetic information, familial status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will provide reasonable accommodation to known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

Please note that certain background checks will form part of the recruitment process and will be conducted in accordance with the law of the country where the position is based, including identity verification and verification of educational qualifications.

Salary Range (annually)

$202,000.00 - $336,600.00