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.
Contacts:
• 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.
Knowledge/Skill/Abilities:
• 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.
• SIMCYP
• NONMEM
• Phoenix
• WinNonLin
• R
• SAS
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%).
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TO APPLY FOR THIS POSITION: Please submit a resume/CV and cover letter to
[email protected] 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 www.c-path.org
Please note: only those applicants authorized to work in the United States
without corporate sponsorship need apply.