Dear all,
Multiple modeling and data analytics full time employment opportunities are
available in the Division of Quantitative Methods and Modeling (DQMM) in the
Office of Research and Standards (ORS) within the Office of Generic Drugs (OGD)
in the U.S. Food and Drug Administration (FDA) located in Silver Spring, MD
20903.
The DQMM is a fast-paced, dynamic scientific environment with opportunities to
work with dedicated, energetic senior scientists and researchers who want to
make a difference and improve public health. We conduct Generic Drug User Fee
Amendments (GDUFA) regulatory science and research activities based on
quantitative clinical pharmacology, physiologically based pharmacokinetic
models, PK profile assessment for modified release products, big data analytics
including post market product performance evaluations, and novel quantitative
methods for equivalence assessment. The relevant regulatory activities include
but are not limited to general and product specific guidance development,
abbreviated new drug application (ANDA) review consults, citizen petitions,
controlled correspondence, pre-ANDA meetings, and post-marketing safety
surveillance. We coordinate modeling, simulation, data analysis, and data
mining and establish the scientific computing infrastructure for OGD. In
addition, we develop innovative quantitative approaches to improve regulatory
decision making for generic drugs by fully utilizing the extensive resources
available to FDA.
Some of the exciting areas that we are involved are as follows:
· Model-based delivery system assessment
· Innovative approaches to establish active ingredient
sameness/pharmaceutical equivalence for complex drug substances
· In vitro bioequivalence analyses taking into consideration of high
batch to batch variation
· Clinical trial simulation of clinical endpoint (PK and/or PD)
bioequivalence study, average bioequivalence, reference scale average
bioequivalence study (for narrow therapeutic index drugs and highly variable
drugs), adaptive study design, Bayesian bioequivalence, power and sample size
analysis
· Application of physiologically based pharmacokinetic (PBPK) models for
non-oral drug products to help develop new bioequivalence methods for locally
acting drug products administered via non-oral routes of administration
· PK/PD modeling of narrow therapeutic index drugs and complex drug
products and clinical trial simulation to aid risk-based bioequivalence
evaluation
· Conventional and model-based meta-analysis on drugs within same class
or different classes
· Modeling and simulation of modified release solid oral products
(including absorption models, in vitro - in vivo correlations and
pharmacokinetic/pharmacodynamic [PK/PD] modeling) to ensure the consistency and
quality of bioequivalence recommendations from OGD
· Developing/applying novel analysis approaches to detect and assess
safety signals of generic products
· Developing systems pharmacology-based methodologies to understand and
predict drug actions underlying both therapeutic effect and adverse reactions
· Developing big data techniques to predict FDA workload
· Establishing data infrastructure to increase ANDA review efficiency and
quality by providing integrated and readily searchable information based on
available NDAs and ANDA datasets regarding drug efficacy and safety profiles
The incumbent provides scientific expertise in one or more of the following
areas:
Quantitative clinical pharmacology
Physiologically based pharmacokinetic modeling for systemically or locally
acting products
Data analytics for health outcomes and big data
Novel methodologies for bioequivalence evaluation and study design
Formulation science and technology
Desired Qualifications:
· Ph.D., M.D., Pharm.D., or other qualified scientists holding advanced
degree(s) such as Clinical Pharmacology, Pharmaceutical Sciences,
Pharmacometrics, Chemistry, Statistics, and/or Engineering.
· Hands-on experience with certain modeling and simulation software
(e.g., NONMEM, SAS, Splus/R, Phoenix, Monolix, MATLAB, C++, GastroPlus, Simcyp,
and PKSim etc.)
· Experience in pharmaceutical abuse-deterrent opioid formulation
development, physical manipulation methods, and analysis of in vitro
(dissolution) and in vivo (pharmacokinetics) results related to abuse
deterrence properties
· Experience in pharmaceutical dosage form development, technology
transfer and a strong desire to analyze and interpret in vitro (dissolution)
and in vivo (pharmacokinetics) results related to product development of
complex oral dosage forms.
· Experience in methodology development in linear and nonlinear mixed
effect modeling, bioequivalence analysis, sequential and adaptive study design,
power and sample size estimations.
· Broad technical knowledge about biopharmaceutics, formulation,
dissolution, stability and manufacturability
· Good knowledge of formulation design, biopharmaceutics, data analysis
and/or modeling and simulation principles
· Strong organizational and documentation skills, scientific
problem-solving skills
· Good scientific writing, communication, critical thinking, and
interpersonal skills
Additional Qualifications for Senior Scientists/Reviewers, Scientific Leads or
Team Leads:
The incumbent should have a minimum of 3 years of experience in an industrial
or regulatory setting with a well-established record in the relevant modeling
or data analytics field.
The incumbent prepares a comprehensive summary of his/her reviews and presents
substantive recommendations for revision/acceptance/rejection.
The incumbent is responsible for planning, coordinating, and evaluating the
programs and activities of the Division for the professional scientific
discipline for which he/she is responsible. The responsibility requires the
scientist to maintain close personal contact with the “state of the science” to
promote the most advanced theories and practices in the scientific field into
divisional and ORS programs.
The incumbent concentrates on complex, long-term, and emerging problems related
to generic product development and regulation. The scientist keeps fully
abreast of crucial and precedent setting cases under review within the division
and regulated industry, as well as related cases in ORS, and briefs the
Division Director, the Division Deputy Director and the team on all scientific
interpretations and analyses.
The incumbent participates in meetings within the division and with other
divisions and offices in OGD and serves as expert advisor on problems related
to his/her area of expertise. This requires a continuing knowledge of the
research in both the scientific discipline and the regulated industry as these
studies impact the area of science for which the scientist is responsible.
The incumbent leads or serves as a member of divisional task forces and study
groups called to consider problems or provide direction in scientific
expertise. As required, the incumbent conceives the mission for such groups,
develops propositions for study and speaks for the Division, ORS, OGD on issues
in the scientific discipline. When appropriate, represents discipline to the
professional and academic communities and to regulated industry. He/she meets
with representatives of the regulated firms with problems in the scientific
discipline. He/she maintains continuing liaison with other organizations within
ORS, OGD, CDER and the Agency and other agencies. He/she provides
consultations, opinions, and endorsements regarding the scientific discipline.
The incumbent coaches the team in the selection and application of appropriate
problem-solving quantitative methods and techniques, provides advice on work
methods, practices and procedures, and assists the team and/or individual
members in identifying the parameters of a viable solution.
The incumbent participates in identifying, distributing and balancing workload
and tasks among employees in accordance with established work flow, skill level
and/or occupational specialization. He/she makes adjustments to the workload in
accordance with established priorities to ensure timely and successful
completion of assigned team tasks. He/she ensures that each employee has an
integral role in developing the final team product.
If you would like to be considered for these opportunities, please submit a
letter of interest and a copy of your CV/resume [email protected]
Best regards，
Kevin