Medical Director – Endocrinology

• Responsible for providing medical and scientific support across clinical development activities, with emphasis on protocol development and study design review, clinical data interpretation, site and PI interaction, regulatory response documents, ongoing safety review, and medically relevant vendor and operational deliverables.


• Works cross-functionally with Clinical Operations, Regulatory, Biostatistics, Data Management, Drug Safety, Clinical Pharmacology, Translational Medicine, Medical Writing, vendors, and investigators to ensure clinical accuracy, participant safety, protocol alignment, and timely execution of study deliverables across Phase 1-4 programs.


• Provide medical and scientific input into clinical study designs, synopses, protocols, amendments, informed consent forms, and related study documents across early- and late-stage development


• Review study objectives, endpoints, eligibility criteria, safety monitoring, visit schedules, biomarker strategies, and operational feasibility to ensure studies are clinically meaningful, patient-appropriate, executable, and aligned with regulatory objectives


• Review draft tables, figures, listings, data summaries, and clinical narratives for accurate presentation and appropriate interpretation of safety, efficacy, pharmacodynamic, laboratory, and subject-level data


• Support the drafting, medical review, and finalization of health authority, ethics committee, IRB, EU CTR, CTA/RFI, and related response documents, ensuring scientific accuracy, clinical relevance, and alignment with the protocol, development strategy, benefit-risk position, and cross-functional input.


• Identify medical or scientific inconsistencies, missing analyses, data-quality issues, and presentation or interpretation concerns; partner with Biostatistics, Data Management, Clinical Operations, Drug Safety, and Medical Writing to resolve issues before internal or external use


• Perform ongoing medical review of study outputs, safety listings, laboratory data, protocol deviations, concomitant medications, data review meeting materials, and other emerging clinical data to identify potential safety signals, data-quality issues, or clinically relevant trends


• Provide medical interpretation of adverse events, laboratory abnormalities, safety trends, and clinically relevant subject-level data; escalation participant-safety, study-integrity, or decision-critical issues when appropriate


• Review study-related vendor manuals, process documents, data-transfer specifications, assessment plans, imaging or device instructions, patient-facing materials, and site guidance for medical appropriateness, protocol alignment, feasibility, and participant focus


• Collaborate with internal functions, vendors, and external investigators to synthesize input, resolve inconsistencies, present data, and drive documents and decisions to completion under time-sensitive conditions

Requirements

• MD or DO degree with accredited residency training and board certification in relevant clinical specialty for the therapeutic area required


• 2+ years of experience in clinical research and development (Phase 1-4) in either a pharmaceutical/biotechnology company or a clinical research/academic environment or related experience required


• Recognized as an internal thought leader with extensive technical and business expertise within a strategic organization


• Applies strong medical judgment, clinical development experience, and scientific rigor to complex development questions and cross-functional deliverables


• Communicates clearly in writing and verbally, with the ability to summarize medical issues, identify decision points, and provide pragmatic recommendations


• Works independently, manages multiple priorities, and delivers high-quality document review and data interpretation under compressed timelines


• Operates effectively in a matrix environment and builds productive relationships with internal teams, vendors, investigators, and other external partners


• Experience in endocrinology, pediatric endocrinology, rare diseases, metabolic disease, or a related translational/safety-relevant specialty is preferred


• Hands-on experience in clinical research and drug development, including early clinical development, protocol design, endpoint selection, benefit-risk assessment, safety monitoring, and interpretation of emerging efficacy and safety data across Phase 1-4 studies


• Knowledge of Good Clinical Practice, global clinical trial regulations, EU CTR/CTA processes, health authority questions, RFI responses, protocol amendments, and ethics committee or IRB interactions


• Ability to review subject-level data, adverse events, laboratory trends, protocol deviations, concomitant medications, safety listings, and draft TFLs, and to distinguish data-quality issues from true medical signals


• Working understanding of how protocols, SAPs, estimands/endpoints, analysis sets, visit windows, and TFL shells connect to final clinical interpretation and regulatory communication


• Demonstrated ability to collaborate with Clinical Operations, Regulatory, Biostatistics, Data Management, Drug Safety, Clinical Pharmacology, Translational Medicine, Medical Writing, vendors, and external investigators to resolve issues and complete deliverables

Core Competencies

Demonstrates expertise in clinical research and development, particularly in protocol design, safety monitoring, and data interpretation across Phase 1-4 studies. Possesses strong medical judgment and the ability to collaborate effectively with cross-functional teams and external partners.

Highest-signal resume keywords

• MD Or DO Degree


• Clinical Research Experience


• Good Clinical Practice Knowledge


• Data Interpretation Skills


• Cross-Functional Collaboration

ATS Optimization Keywords

Hard Skills

• Protocol Development


• Study Design Review


• Clinical Data Interpretation


• Safety Monitoring


• Adverse Event Review


• Endpoint Selection


• Benefit-Risk Assessment


• Drafting Regulatory Documents


• Clinical Trial Regulations


• Data Quality Analysis

Soft Skills

• Clear Communication


• Independent Work


• Time Management


• Relationship Building


• Problem Solving

Certifications & Qualifications

• Board Certification In Relevant Clinical Specialty

Industry Keywords

• Phase 1-4 Clinical Development


• Endocrinology


• Pediatric Endocrinology


• Rare Diseases


• Metabolic Disease


• Translational Medicine


• Health Authority Interactions


• Ethics Committee


• IRB Interactions


• EU CTR/CTA Processes

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