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.
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