FDA Fellowship in Quantitative Regulatory Science: Integrating Nonclinical and Clinical Data to Support Targeted Therapy Development

We need to output HTML fragment with sections: maybe About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We need to include only sections with real content. We need to parse the posting. Key info: - Organization: FDA, reference code, etc. Not needed as heading. - Description: includes research project, learning objectives, mentor, appointment start date, length, level of participation, stipend, citizenship requirements, background investigation, etc. - Qualifications: master's or doctoral degree in relevant fields. - Eligibility: US citizen or lived in US 36 of past 60 months. - Also mention: participant will receive a monthly stipend commensurate with educational level and experience (but that's vague; we should not create Pay section if it's just "commensurate with educational level and experience" which is placeholder? The rule: never emit a heading followed by filler/placeholder text (e.g., "commensurate with experience", "not specified", "N/A", "varies", "TBD") and never create Pay/Schedule/Benefits sections unless the posting actually states them. Here stipend is described as "commensurate with educational level and experience." That's placeholder-like. So we should NOT create a Pay section. - Benefits: Not mentioned besides stipend (which we are not using). No explicit benefits like health insurance? It says "Proof of health insurance is required for participation in this program." That's a requirement, not a benefit. Also "Participants do not become employees... there are no employment-related benefits." So no benefits section. - Schedule: Level of participation: full time. That's schedule info. Could we create a Schedule section? The rule: never create Schedule section unless posting actually states them. It does state "Level of Participation: The appointment is full time." That's a schedule detail. So we can include a Schedule section with that info. - Responsibilities: The posting includes research project description, learning objectives, mentor, etc. Could be considered responsibilities. We can put under Responsibilities. - Requirements: citizenship, background check, health insurance proof, eligibility (US citizen or 36 months), maybe also degree requirement. - Qualifications: degree requirement. - Skills: maybe not explicit; we could omit. - About the role: could be description of FDA, CDER, etc. Could be a section. We need to avoid boilerplate like application instructions, EEO, etc. Remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. We need to preserve all substantive information. Let's extract substantive content: - Organization: FDA, Office of Translational Sciences (OTS) Office of Clinical Pharmacology (OCP) Division of Applied Regulatory Science (DARS) at CDER located in Silver Spring, Maryland. - Mission: CDER ensures safe and effective drugs, regulates OTC and prescription drugs, includes biologics and generics. - Research Project: fellowship focuses on advancing regulatory science of targeted therapies, including peptides and oligonucleotide therapeutics (ONTs), through integration of nonclinical safety data evaluation and Model-Informed Drug Development (MIDD) approaches. Under mentor guidance, investigate how available nonclinical and early clinical data can be leveraged more effectively to support key drug development decisions — including characterization of safety profiles and optimization of dosing strategies — in ways that complement or improve upon conventional development paradigms. - Learning Objectives: structured learning opportunities in regulatory science and computational modeling applications in drug development and use of artificial intelligence for data mining. Gain experience in regulatory toxicology assessment, computational modeling methodologies, and FDA's drug evaluation processes. Develop competencies in data curation and analysis. Opportunities to present research results at internal and external scientific conferences and participate in writing high-impact scientific manuscripts. - Mentor: Lars Johannesen (Lars.Johannesen@fda.hhs.gov). Contact for research questions. - Anticipated Appointment Start Date: 2026. Start date flexible, depends on factors. - Appointment Length: initially one year, may be renewed upon recommendation of FDA and contingent on availability of funds. - Level of Participation: full time. - Participant Stipend: monthly stipend commensurate with educational level and experience. (We might not include as Pay.) - Citizenship Requirements: opportunity available to U.S. citizens, Lawful Permanent Residents (LPR), and foreign nationals. Non-U.S. citizen applicants should refer to Guidelines for Non-U.S. Citizens Details page for valid immigration statuses. - Additional eligibility: Affirmation: I am a U.S. citizen, or I have lived in the United States for at least 36 out of the past 60 months. (36 months do not have to be consecutive.) - Proof of health insurance required for participation. - Participants do not become employees of FDA, DOE or program administrator, and there are no employment-related benefits. - Completion of a successful background investigation by OPM required for onboarding at FDA. OPM can complete background investigation only for individuals, including non-US Citizens, who have resided in the US for a total of three of the past five years. - Qualifications: The qualified candidate should have received or be currently pursuing a master's or doctoral degree in one of the relevant fields. - Eligibility Requirements (maybe same as citizenship). Also mention degree: Master's Degree or Doctoral Degree. Discipline(s): Computer, Information, and Data Sciences; Life Health and Medical Sciences; Mathematics and Statistics. (List of subfields.) We need to format as HTML with headings

for sections. Potential sections: - About the role (maybe includes FDA description, location, mission) - Responsibilities (research project, learning objectives, mentor) - Requirements (citizenship, health insurance, background check, eligibility affirmation) - Qualifications (degree, disciplines) - Schedule (full time) We could also have a section for Appointment Details (start date, length) but maybe incorporate into About the role or Responsibilities? The rule: prefer few substantive sections over many thin ones. Could combine start date and length into About the role or Responsibilities? But they are separate details. However we could put them under About the role as part of description. But we need to avoid filler. Let's decide sections: 1. About the role: includes FDA office, location, mission, appointment start date, length, level of participation (full time). Could also include stipend? But stipend is placeholder; we skip. 2. Responsibilities: research project description, learning objectives, mentor contact. 3. Requirements: citizenship, health insurance proof, background investigation, eligibility affirmation (US citizen or 36 months), maybe also non-US citizen guidelines. 4. Qualifications: degree requirement, disciplines. We could also have a section for Appointment Details (start date, length) but maybe incorporate into About the role. We must not repeat job title as heading. No Job ID. We must not include application instructions, reference code, how to apply, deadline, etc. So remove those. We must not include boilerplate like "All documents must be in English..." etc. That's application instructions; remove. We must not include "If you have questions, send an email..." etc. Remove. We must not include "Application Deadline". Remove. We must not include "Proof of health insurance is required for participation in this program." That's a requirement, keep. We must not include "Participants do not become employees..." that's a note about benefits; could be included under Requirements or maybe as a note but it's substantive: says no employment-related benefits. Could be included under Requirements as a note. We must not include "This program, administered by ORAU..." etc. That's boilerplate about program admin; maybe not needed? It's substantive about program administration but could be considered boilerplate? It's describing the program admin; maybe we can keep as part of About the role? It's not essential to the role but it's about the program. The instruction: preserve ALL substantive information; do NOT invent or summarize away detail. So we should keep that info unless it's clearly boilerplate like cookie/navigation/legal/EEO/equal-opportunity/scam-warning. This is about program administration; it's substantive. However it's somewhat generic. But we can keep it under About the role. We also need to include the eligibility affirmation statement: "Affirmation I am a U.S. citizen, or I have lived in the United States for at least 36 out of the past 60 months. (36 months do not have to be consecutive.)" That's a requirement. Now format. We'll produce:

About the role

... paragraphs ...

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• for lists. We need to list disciplines maybe as list. Let's craft. About the role paragraph: Include FDA Office and Location, mission, appointment start date, length, level of participation, program admin details. Responsibilities: research project, learning objectives, mentor. Requirements: citizenship, health insurance proof, background investigation, eligibility affirmation, note about non-employment benefits. Qualifications: degree requirement, disciplines list. Schedule: maybe not needed if we included level of participation in About the role. But we could still have Schedule section with "Full time". However we already included level of participation in About the role; we could avoid duplication. The rule: prefer few substantive sections over many thin ones. So maybe we omit separate Schedule section and include full time in About the role. Thus sections: About the role, Responsibilities, Requirements, Qualifications. Check each for substantive content. About the role content: - FDA Office and Location: Office of Translational Sciences (OTS) Office of Clinical Pharmacology (OCP) Division of Applied Regulatory Science (DARS) at the Center for Drug Evaluation and Research (CDER) of the U.S. Food and Drug Administration (FDA) located in Silver Spring, Maryland. - Mission: CDER performs essential public health task by making sure safe and effective drugs are available; regulates OTC and prescription drugs, including biologics and generics. - Research Project description? Might be better in Responsibilities. - Appointment Start Date: Anticipated Appointment Start Date: 2026. Start date is flexible and will depend on a variety of factors. - Appointment Length: initially one year, may be renewed upon recommendation of FDA and contingent on availability of funds. - Level of Participation: full time. - Program admin: This program, administered by ORAU through its contract with the U.S. Department of Energy to manage the Oak Ridge Institute for Science and Education, was established through an interagency agreement between DOE and FDA. We could also mention stipend? But it's placeholder; skip. Now Responsibilities: - Research Project: This fellowship focuses on advancing the regulatory science of targeted therapies, including peptides and oligonucleotide therapeutics (ONTs), through the integration of nonclinical safety data evaluation and Model-Informed Drug Development (MIDD) approaches. Under the guidance of a mentor, you will investigate how available nonclinical and early clinical data can be leveraged more effectively to support key drug development decisions — including the characterization of safety profiles and the optimization of dosing strategies — in ways that complement or improve upon conventional development paradigms. - Learning Objectives: As a participant, you will have structured learning opportunities in regulatory science and computational modeling applications in drug development and use of artificial intelligence for data mining. You will gain experience in regulatory toxicology assessment, computational modeling methodologies, and FDA's drug evaluation processes. Additionally, you will develop competencies in data curation and analysis. The appointment will also allow opportunities to present research results at internal and external scientific conferences and participate in writing high-impact scientific manuscripts. - Mentor: The mentor for this opportunity is Lars Johannesen (Lars.Johannesen@fda.hhs.gov). If you have questions about the nature of the research, please contact the mentor. Now Requirements: - Citizenship Requirements: This opportunity is available to U.S. citizens, Lawful Permanent Residents (LPR), and foreign nationals. Non-U.S. citizen applicants should refer to the Guidelines for Non-U.S. Citizens Details page of the program website for information about the valid immigration statuses that are acceptable for program participation. - Eligibility affirmation: Affirmation I am a U.S. citizen, or I have lived in the United States for at