Who We Are : Critical Path Institute (C-Path)
The Critical Path Institute (C-Path) is a global, nonprofit organization created to foster development and regulatory qualification of new evaluation tools and standards for drug therapy trials, in order to accelerate medical product approval and adoption.
C-Path acts as a neutral third party to bring together public-private consortia of industry, academia and government for pre competitive collaboration and sharing of scientific data.
Our continued success is made possible by a combination of public and private support from those who share our vision to accelerate a path to a healthier world including our own valued team members.
Who You Are : Scientific Director
You are purpose driven; making a difference is important to you. You strive to be the best you can be at whatever you do, but realize that the process can be even more powerful when information, ideas, and perspectives are shared with a diverse team.
You are not afraid of change; in fact you enjoy how projects evolve and challenge you to find innovative ways to do your work.
Having work / life balance is important to you because you know it results in greater creativity and a calm mind. You know your level of expertise but are open to continual improvement and growth.
Job Purpose Summary :
You will be part of the Quantitative Medicine expert team at C-Path, working along with the executive director and consortium staff.
The position entails partnering with the internal and external teams to leverage integrated subject level data in order to lead the development of drug development platforms through the consortium.
You will closely engage with clinicians, statisticians, pharmacometricians 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 quantitative pharmacology and modeling and simulation components of the consortium.
The individual is responsible for development and execution of the plans for the proposed quantitative drug development tools for type 1 diabetes, 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 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 scientists and external opinion leaders.
The individual is expected to influence the external environment by advancing their discipline through external presentations and publications
Additionally, the Scientific Director will develop and execute the strategic plan and priorities for the Consortium, as well as regulatory submission documents for both the FDA and EMA.
Plans and directs clinical pharmacology and modeling and simulation components of specific C-Path 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 high-quality 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.
Clearly and concisely explaining quantitative modeling plans to consortium members and the regulatory authorities, as well as external stakeholders and funders with a limited understanding of the field
Coaches and helps develop other members of the consortia teams as appropriate.
Responsible for designing cost-efficient analysis plans.
Responsible for recommending and / or working within budget allocated to the consortium and the Quantitative Medicine Team.
Aids in the management of staff to oversee project management, and project coordination support of Consortium research activities.
Education and Training :
PharmD, PhD, or equivalent training
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.
Immunology : knowledge of auto-immune diseases in general, and type 1 diabetes is preferable.
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.
Proficiency or experience working with regulators is preferred but not required.
Proficiency or experience working with longitudinal data from digital monitoring devices is desired.
Work independently and lead projects, as well as professing the ability to operate as a part of a team and take advice and consideration from consortium members.
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.
Fundamental understanding of challenges to and opportunities currently presented to the development of therapies aimed at the prevention of T1D and the role of islet autoantibodies.
Consideration from the from industry, regulatory, and academic perspective.
Demonstrated aptitude for leading and managing complex teams and deliverables; ability to plan, identify contingencies, course correct, and evaluate project success.
Knowledge of FDA / EMA regulations and requirements.
Working knowledge of good clinical practice .
Application of effective management, interpersonal, negotiation, and problem-solving skills.
Ability to rapidly adapt to shifting priorities, demands, and timelines. Willingness to "roll up sleeves" and fill gaps when needed.
Experience with contracts management; effective negotiation and problem-solving skills.
Entrepreneurial, visionary, and enthusiastic. Practices the highest level of integrity and possesses a core value system consistent with C-Path's code of conduct.
Demonstrated ability to work collaboratively, and use an inclusive and consultative approach to problem solving and decision making
Exceptional communication skills in a range of applications : interpersonal relationships, formal presentations, written electronic communications, and scientific and regulatory writing.
Exercise sound business judgment when making decisions and adhere to external and internal policies and regulations.
Ability to successfully anticipate issues or challenges and proactively address without being specifically directed.
Use sound judgment when working with critical or confidential information.
Proficient use of Microsoft Office Suite : Word, Excel, PowerPoint, Outlook.
Extensive hands-on experience with analyses using pharmacometric modeling and simulation tools (e.g., NONMEM, Phoenix Winnonlin, NLME, Stan, BUGS)
Proficient in programming in at least one of the following : R, Python or SAS
Additional expertise with other quantitative tools (e.g., SIMCYP, GastroPlus, Matlab) or programming languages (e.g., C++, Java, Perl) a plus
Travel Demands : Travel for out-of-town meetings (max 10 20%).