Senior Director, Quantitative Pharmacology

As a Senior Director in Pharmacometrics (PPK/PD, QP, or CP as appropriate), this individual is accountable for the delivery of support for a portion of the company’s portfolio of research & development programs, within their pharmacometric discipline. In this capacity the Senior Director is accountable for their team’s timely and accurate delivery of needed quantitative analyses, interpretation, and messaging to PMx management, as well as the timely delivery of well-constructed and well-messaged reports for PMx review.

This person is also accountable for the professional development of their direct reports, and adherence to the applicable PMx working practices, relevant company SOPs and Working Practices, and the corporate code of ethical conduct.

Responsibilities

• Is accountable for the performance and results of team and is responsible for performance

• management and assessment of team.

• Provides technical oversight, guidance, training, and mentoring to ensure the success of the function and of the individual contributors.

• 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.

• Adapts departmental plans and priorities to address resource and operational challenges.

• Addresses issues with impact beyond own team, based on knowledge of related disciplines.

• Has a strong publication record and actively publishes work in scientific literature

Knowledge

• Is 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.

• Is a capable people-manager who can inspire and lead colleagues to deliver PMx goals.

• Possesses a deep understanding of scientific literature and technical skills in a number of PK/PD methods and techniques. Has extensive knowledge base of the work in overall scientific community in own discipline.

• Is recognized as an expert in own area within the organization.

• Has 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.

• Decisions are guided by policies, procedures and business plan; receives guidance from head of function.

• 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.

• Has strong collaborative skills and is effective at building alliances across functions.

• Has ability to effectively influence colleagues and multi-disciplinary project teams.

Job Complexity

• Excellent interpersonal and communication skills both written and oral and ability to communicate complex information succinctly.

• Strong collaborative skills and effective at building alliances across functions.

• Ability to effectively influence colleagues and multi-disciplinary project teams.

• Able to handle all types of projects and leverage higher level staff for technical input and brainstorming to implement solutions for complex projects. Able to work with considerable ambiguity.

• Ability to inspire internal staff to be active professionally and help them achieve external presence. Good mentorship. Identifies business problems and works in team to craft solutions. Able to interact with regulatory agencies without supervision, and with company to develop regulatory strategy.

• Active professionally and finds ways to represent company externally and to sponsor internal staff to be active.

• Leader of cross-functional process initiatives.

• Works with senior management on solving issues and to engage department in new areas. Able

  to bring in consultants to further new initiatives.

• Understands long-term career opportunities and can guide junior PMx staff on potential directions.