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[NMusers] Job opportunities at FDA

From: Kevin Feng <>
Date: Tue, 6 Aug 2019 16:18:07 -0400

Dear all,
Multiple modeling and data analytics full time employment opportunities are a=
vailable in the Division of Quantitative Methods and Modeling (DQMM) in the O=
ffice of Research and Standards (ORS) within the Office of Generic Drugs (OG=
D) in the U.S. Food and Drug Administration (FDA) located in Silver Spring, M=
D 20903.
The DQMM is a fast-paced, dynamic scientific environment with opportunities t=
o work with dedicated, energetic senior scientists and researchers who want t=
o make a difference and improve public health. We conduct Generic Drug User =
Fee Amendments (GDUFA) regulatory science and research activities based on q=
uantitative clinical pharmacology, physiologically based pharmacokinetic mod=
els, PK profile assessment for modified release products, big data analytics=
 including post market product performance evaluations, and novel quantitati=
ve methods for equivalence assessment. The relevant regulatory activities i=
nclude but are not limited to general and product specific guidance developm=
ent, abbreviated new drug application (ANDA) review consults, citizen petiti=
ons, controlled correspondence, pre-ANDA meetings, and post-marketing safet=
y surveillance. We coordinate modeling, simulation, data analysis, and data m=
ining and establish the scientific computing infrastructure for OGD. In addi=
tion, we develop innovative quantitative approaches to improve regulatory de=
cision making for generic drugs by fully utilizing the extensive resources a=
vailable 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/p=
harmaceutical equivalence for complex drug substances

· In vitro bioequivalence analyses taking into consideration of h=
igh batch to batch variation

· Clinical trial simulation of clinical endpoint (PK and/or PD) b=
ioequivalence study, average bioequivalence, reference scale average bioequi=
valence study (for narrow therapeutic index drugs and highly variable drugs)=
, adaptive study design, Bayesian bioequivalence, power and sample size anal=

· Application of physiologically based pharmacokinetic (PBPK) mod=
els for non-oral drug products to help develop new bioequivalence methods fo=
r locally acting drug products administered via non-oral routes of administr=

· PK/PD modeling of narrow therapeutic index drugs and complex dr=
ug products and clinical trial simulation to aid risk-based bioequivalence e=

· 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 pharmacok=
inetic/pharmacodynamic [PK/PD] modeling) to ensure the consistency and quali=
ty of bioequivalence recommendations from OGD

· Developing/applying novel analysis approaches to detect and ass=
ess safety signals of generic products

· Developing systems pharmacology-based methodologies to understa=
nd and predict drug actions underlying both therapeutic effect and adverse r=

· Developing big data techniques to predict FDA workload

· Establishing data infrastructure to increase ANDA review effici=
ency and quality by providing integrated and readily searchable information b=
ased on available NDAs and ANDA datasets regarding drug efficacy and safety p=

The incumbent provides scientific expertise in one or more of the following a=
Quantitative clinical pharmacology
 Physiologically based pharmacokinetic modeling for systemically or locally a=
cting 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 a=
dvanced degree(s) such as Clinical Pharmacology, Pharmaceutical Sciences, Ph=
armacometrics, Chemistry, Statistics, and/or Engineering.
· Hands-on experience with certain modeling and simulation soft=
ware (e.g., NONMEM, SAS, Splus/R, Phoenix, Monolix, MATLAB, C++, GastroPlus,=
 Simcyp, and PKSim etc.)
· Experience in pharmaceutical abuse-deterrent opioid formulati=
on development, physical manipulation methods, and analysis of in vitro (dis=
solution) and in vivo (pharmacokinetics) results related to abuse deterrence=
· Experience in pharmaceutical dosage form development, technol=
ogy transfer and a strong desire to analyze and interpret in vitro (dissolut=
ion) and in vivo (pharmacokinetics) results related to product development o=
f complex oral dosage forms.
· Experience in methodology development in linear and nonlinear=
 mixed effect modeling, bioequivalence analysis, sequential and adaptive stu=
dy design, power and sample size estimations.
· Broad technical knowledge about biopharmaceutics, formulation=
, dissolution, stability and manufacturability
· Good knowledge of formulation design, biopharmaceutics, data a=
nalysis and/or modeling and simulation principles
· Strong organizational and documentation skills, scientific pr=
oblem-solving skills
· Good scientific writing, communication, critical thinking, an=
d interpersonal skills
Additional Qualifications for Senior Scientists/Reviewers, Scientific Leads o=
r Team Leads:
The incumbent should have a minimum of 3 years of experience in an industria=
l or regulatory setting with a well-established record in the relevant model=
ing or data analytics field.
The incumbent prepares a comprehensive summary of his/her reviews and presen=
ts substantive recommendations for revision/acceptance/rejection.
The incumbent is responsible for planning, coordinating, and evaluating the p=
rograms and activities of the Division for the professional scientific disci=
pline for which he/she is responsible. The responsibility requires the scie=
ntist to maintain close personal contact with the “state of the scie=
nce” to promote the most advanced theories and practices in the scie=
ntific field into divisional and ORS programs.
The incumbent concentrates on complex, long-term, and emerging problems rela=
ted to generic product development and regulation. The scientist keeps fully=
 abreast of crucial and precedent setting cases under review within the divi=
sion and regulated industry, as well as related cases in ORS, and briefs the=
 Division Director, the Division Deputy Director and the team on all scienti=
fic interpretations and analyses.
The incumbent participates in meetings within the division and with other di=
visions and offices in OGD and serves as expert advisor on problems related t=
o his/her area of expertise. This requires a continuing knowledge of the re=
search 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 stud=
y groups called to consider problems or provide direction in scientific expe=
rtise. As required, the incumbent conceives the mission for such groups, de=
velops propositions for study and speaks for the Division, ORS, OGD on issue=
s in the scientific discipline. When appropriate, represents discipline to t=
he professional and academic communities and to regulated industry. He/she m=
eets with representatives of the regulated firms with problems in the scient=
ific discipline. He/she maintains continuing liaison with other organization=
s within ORS, OGD, CDER and the Agency and other agencies. He/she provides c=
onsultations, opinions, and endorsements regarding the scientific discipline=
The incumbent coaches the team in the selection and application of appropria=
te problem-solving quantitative methods and techniques, provides advice on w=
ork methods, practices and procedures, and assists the team and/or individua=
l members in identifying the parameters of a viable solution.
The incumbent participates in identifying, distributing and balancing worklo=
ad and tasks among employees in accordance with established work flow, skill=
 level and/or occupational specialization. He/she makes adjustments to the w=
orkload in accordance with established priorities to ensure timely and succe=
ssful completion of assigned team tasks. He/she ensures that each employee h=
as an integral role in developing the final team product.
If you would like to be considered for these opportunities, please submit a l=
etter of interest and a copy of your CV/resume toJeannie.Caldwell_at_fda.hhs.go=
Best regards,

Received on Tue Aug 06 2019 - 16:18:07 EDT

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