Medical Director – Endocrinology

Darum lohnt es sich

pul /brliResponsible 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. /li /brliWorks 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. /li /brliProvide medical and scientific input into clinical study designs, synopses, protocols, amendments, informed consent forms, and related study documents across early- and late-stage development /li /brliReview 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 /li /brliReview draft tables, figures, listings, data summaries, and clinical narratives for accurate presentation and appropriate interpretation of safety, efficacy, pharmacodynamic, laboratory, and subject-level data /li /brliSupport 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. /li /brliIdentify 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 /li /brliPerform 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 /li /brliProvide 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 /li /brliReview 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 /li /brliCollaborate 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 /li /br /ul /brh3Requirements /h3 /brul /brliMD or DO degree with accredited residency training and board certification in relevant clinical specialty for the therapeutic area required /li /brli2+ 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 /li /brliRecognized as an internal thought leader with extensive technical and business expertise within a strategic organization /li /brliApplies strong medical judgment, clinical development experience, and scientific rigor to complex development questions and cross-functional deliverables /li /brliCommunicates clearly in writing and verbally, with the ability to summarize medical issues, identify decision points, and provide pragmatic recommendations /li /brliWorks independently, manages multiple priorities, and delivers high-quality document review and data interpretation under compressed timelines /li /brliOperates effectively in a matrix environment and builds productive relationships with internal teams, vendors, investigators, and other external partners /li /brliExperience in endocrinology, pediatric endocrinology, rare diseases, metabolic disease, or a related translational/safety-relevant specialty is preferred /li /brliHands-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 /li /brliKnowledge 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 /li /brliAbility 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 /li /brliWorking understanding of how protocols, SAPs, estimands/endpoints, analysis sets, visit windows, and TFL shells connect to final clinical interpretation and regulatory communication /li /brliDemonstrated 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 /li /br /ul /brh3Core Competencies /h3 /brpDemonstrates 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. /p /brh3Highest-signal resume keywords /h3 /brul /brliMD Or DO Degree /li /brliClinical Research Experience /li /brliGood Clinical Practice Knowledge /li /brliData Interpretation Skills /li /brliCross-Functional Collaboration /li /br /ul /brh3ATS Optimization Keywords /h3 /brh3Hard Skills /h3 /brul /brliProtocol Development /li /brliStudy Design Review /li /brliClinical Data Interpretation /li /brliSafety Monitoring /li /brliAdverse Event Review /li /brliEndpoint Selection /li /brliBenefit-Risk Assessment /li /brliDrafting Regulatory Documents /li /brliClinical Trial Regulations /li /brliData Quality Analysis /li /br /ul /brh3Soft Skills /h3 /brul /brliClear Communication /li /brliIndependent Work /li /brliTime Management /li /brliRelationship Building /li /brliProblem Solving /li /br /ul /brh3Certifications Qualifications /h3 /brul /brliBoard Certification In Relevant Clinical Specialty /li /br /ul /brh3Industry Keywords /h3 /brul /brliPhase 1-4 Clinical Development /li /brliEndocrinology /li /brliPediatric Endocrinology /li /brliRare Diseases /li /brliMetabolic Disease /li /brliTranslational Medicine /li /brliHealth Authority Interactions /li /brliEthics Committee /li /brliIRB Interactions /li /brliEU CTR/CTA Processes /li /br /ul /p