Medical Director

Base pay range$280,000.00/yr - $380,000.00/yrExecutive Consultant-Clinical Development, Medical Affairs and CommercialSenior/Executive Medical Director - Clinical DevelopmentCompany: a leading rare disease biotech companyLocation: New York, US (Hybrid - Remote with 2-3 days per fortnight/ 3 weeks in office). A substantial amount of the business are based in surrounding areas such as Boston, New Jersey and PennsylvaniaAbout Our ClientOur client is a well-established clinical-stage biopharmaceutical company with a focused pipeline of novel therapeutics for rare and orphan diseases. The company has multiple programs in late-stage development approaching key regulatory milestones including NDA submissions and confirmatory studies across metabolic and neurological indications.Position SummaryWe are seeking a hands-on Senior / Executive Medical Director to join the Clinical Development team during an exciting period of growth. This role will provide critical support to the Chief Medical Officer across multiple rare disease programs, with immediate focus on lead programs as the company prepares for NDA submissions and potential confirmatory studies.This role will be an excellent position for a Medical Director who is professionally trained in the following areas:Rare disease or orphan drug developmentKey ResponsibilitiesClinical Development LeadershipLead day-to-day clinical development activities across multiple rare disease programsWrite and review clinical protocols, particularly for Phase 3 studies and open-label extensionsOversee safety summaries and investigator brochure updatesManage expanded access programs (multiple currently ongoing)Design and implement confirmatory studies as required by regulatory agenciesRegulatory & ComplianceSupport FDA meeting preparations and regulatory submissionsEnsure compliance with regulatory requirements across all clinical programsContribute to NDA submission activities and regulatory strategyCross-Functional CollaborationWork closely with Clinical Operations, Data Management, and Medical Affairs teamsCollaborate with MSLs on scientific publications and congress presentationsInterface with external vendors including CROs and statistical consultantsSupport medical monitoring activities as neededStrategic ContributionParticipate in clinical development strategy discussionsProvide medical expertise to support business development activitiesContribute to investor presentations and scientific communicationsRequired QualificationsEducation & TrainingMD degree with completion of US residency trainingResidency in Internal Medicine, Pediatrics, or relevant medical subspecialtyPrevious academic medicine experience preferredIndustry Experience3-5 years of pharmaceutical/biotechnology industry experienceExperience with regulatory submissions and FDA interactionsDemonstrated experience in cross-functional team environmentsCore CompetenciesStrong protocol writing and clinical development skillsRegulatory and compliance expertiseAbility to work independently and manage multiple prioritiesDoer mentality - hands-on approachFlexibility to wear multiple hats in a dynamic biotech environmentWhats on offer:Competitive base salary: $280,000 - $330,000 and compensation package + bonusProfessional development: opportunity to work across multiple rare disease programs, experience with NDA submissions and regulatory interactionsMentorship from an experienced senior leadership teamCollaborative, mission-driven team focused on rare diseasesFlexible hybrid work arrangementDirect impact on bringing life-changing therapies to patientsEnd of refined description. #J-18808-Ljbffr