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Pharmacometrics Position: Associate Director Quantitative Medicine, Critical Path Insititute

From: Corrigan, Brian <Brian.Corrigan>
Date: Mon, 18 Jan 2016 15:50:06 +0000

Job Title: Associate Director Quantitative Medicine
Department: Clinical Pharmacology, Critical Path Institute
Reports to: Director of Clinical Pharmacology
FLSA Status: Full-time; Exempt
Location: Tucson, AZ

Job Purpose Summary: The Associate Director Quantitative Medicine serves as the Quantitative Medicine expert representative for the Coalition Against Major Diseases (CAMD) and the Critical Path for Parkinson’s (CPP) Consortium. The position entails partnering with the consortia teams to integrate subject-level data in order to develop innovative drug development platforms for Mild Cognitive Impairment (MCI) and Parkinson’s disease (PD).

The incumbent will work closely with clinicians, statisticians and other consortia scientists to create development plans that include assessments of endpoints, sources of variability and analysis approaches for the subject-level data, conducive to the development of quantitative drug development platforms. This individual has primary responsibility for the clinical pharmacology and modeling and simulation components of the development plan.

The individual is responsible to develop and execute the plans by using innovative analytical methods to integrate knowledge of pharmacokinetics, biopharmaceutics, pharmacodynamics, patient characteristics and disease states to create models to help optimize doses, dosage regimens and study designs, and to provide quantitative medicine, clinical pharmacology and modeling and simulation support and leadership in the preparation and defense of regulatory submissions.

The individual will routinely interact with internal governance bodies, consortia representatives, regulatory agencies and external opinion leaders. The individual is expected to influence the external environment by advancing their discipline through external presentations and publications.

Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Essential Job Duties and Responsibilities:
• Plans and directs clinical pharmacology and modeling and simulation components of programs.
• Works with multifunctional consortia teams to design, deliver and report the assigned clinical pharmacology and modeling and simulation tasks, and has
scientific accountability for the designated analysis plans and developed quantitative drug development tools.
• Accountable for the development and implementation of modeling and simulation plans based on agreed upon best practices (i.e. model-based drug development).
• Responsible for use of quantitative methods to integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics and disease states to inform optimization of doses, dosage regimens and study designs.
• Responsible for appropriate summarization and interpretation of results of data analyses with respect to their impact on development of quantitative drug development tools.
• During the planning stages, works with consortia teams to ensure that principles of model-based drug development have been applied.
• Prepares scientific summaries and reports which will be used for regulatory submissions and publications.
• Provides quantitative medicine, clinical pharmacology support and leadership in the preparation and defense of regulatory submissions.
• Coaches and develops other members of the consortia teams.
• Responsible for designing cost-efficient analysis plans.
• Responsible for recommending and/or working within budget allocated to the consortia and the Quantitative Medicine Team.
• Other duties and responsibilities may be assigned.

Supervisory Responsibilities: May have one or more administrative or scientific staff as direct reports as the team grows.

• Internal: All C-Path staff.
• External: Collaborates closely with project team members, particularly with clinicians, statisticians and other scientists as well as project managers and data programmers/analysts.

Education and Training:
• PharmD, PhD, or equivalent training or experience in pharmacokinetics, pharmacometrics, clinical pharmacology, systems pharmacology, engineering or related discipline.
• Demonstrated experience with clinical pharmacology aspects of drug development.
• Proficiency or experience working in team settings.
• Proficiency or experience working with regulators is desired.

• Clinical Pharmacology: demonstrates thorough understanding of the following: 1) principles of PK, PK-PD and pharmacology relevant to quantitative drug development platforms; 2) knowledge of phase I-III studies including design and interpretation; and 3) other relevant scientific disciplines, including drug metabolism, drug transport, formulation sciences, biopharmaceutics, pathophysiology and therapeutics.
• Biostatistics: demonstrates thorough understanding of the following: 1) linear and
non-linear mixed-effects models; 2) parametric survival analyses; 3) joint modeling for time-matched data; 4) model-based meta-analyses.
• Software: demonstrates thorough expertise in the use and coding for software platforms such as NONMEM, R and SAS.
• Neuroscience: demonstrates basic knowledge of neurodegenerative diseases, especially Parkinson’s and Alzheimer’s.
• Communication: demonstrates ability to effectively present clinical pharmacology data, development plans and strategies to various audiences in both verbal and written form; demonstrates ability to write clinical pharmacology results, interpretations (including impact) and conclusions for reports and regulatory documents that are clear and concise.
• Scientific Excellence: demonstrates understanding of the complexities and recent developments in clinical pharmacology and the implications for drug development.
• Regulatory Knowledge: understanding of appropriate FDA, EMA and ICH guidelines in the design of analysis plans is desirable.
• Networking and Alliance Building: good interpersonal skills that ensure teamwork and productive interactions among diverse personalities/areas of expertise; ability to garner support and coordinate resources in support of consortia objectives.
• Big Picture/Strategic Thinking: ability to demonstrate a broad perspective on the overall consortia goals and how the Quantitative Medicine Team contributes; ability to understand all stakeholder needs.
• Innovation: constantly looking for new approaches and able to devise/apply new techniques in quantitative medicine, clinical pharmacology and modeling and simulation.
• Courage with Decisiveness to Act: bias towards action to achieve goals; excitement, enthusiasm and a sense of urgency with regard to the development of drug development tools.
• Practice highest level of integrity and core value system consistent with C-Path’s code of conduct.
• Ability to meet target deadlines and manage time effectively, balanced across multiple projects.

Language Ability: Excellent oral, written and virtual communication skills.

Math Ability: Commensurate with PharmD, PhD degree.

Reasoning Ability:
• Exercise sound business judgment when making decisions and adhere to external and internal policies and regulations.
• Strong critical thinking and analytical skills.
• Ability to successfully anticipate issues or challenges and proactively address without being specifically directed.
• Use sound judgment when working with critical or confidential information.

Computer Skills:
• Proficient use of Microsoft Office Suite: Word, Excel, PowerPoint, Outlook.
• Phoenix
• WinNonLin
• R

Physical Demands:
• Regularly required to sit for long periods of time, and occasionally stand and walk about the facility.
• Regularly uses hands to operate computer equipment and other office equipment.
• Close vision required for computer usage.
• Occasionally required to stoop, kneel, and lift up to 25 pounds.
• Travel on occasion for out-of-town meetings (~ 15%).


TO APPLY FOR THIS POSITION: Please submit a resume/CV and cover letter to highlighting how your qualifications match the needs of the position. Indicate the position title for which you are applying in the subject line of your correspondence. Critical Path Institute is an equal opportunity employer. Visit our website at

Please note: only those applicants authorized to work in the United States without corporate sponsorship need apply.
Received on Mon Jan 18 2016 - 10:50:06 EST

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