Project Director

Project Director Stem cell therapy projectGurgaon, IndiaPermanent roleQualifications:PhD (minimum) in Stem cell biologyTissue engineeringBiomedical SciencesOrMD in relevant field with Postdoctoral training in stem cell research or regenerative medicine (preferred)Preferred (not essential): MBA or PMP certificationExperience & Skill set required:8-10 years + experience in stem cell or regenerative medicine researchKnowledge of Good Manufacturing Practices (GMP)Good Lab Practice (GLP)Cell therapy product developmentDesigning &managing preclinical (animal studies)Exposure /Experience in phase1/II clinical trialsWorking with Institutional Review Boards (IRBs) and ethics committeesUnderstanding of clinical trial protocols, patient safety, and informed consentRegulatory & Compliance Knowledge: FDA and EMA regulatory frameworks for cell and gene therapiesInvestigational New Drug (IND) or Investigational Medicinal Product Dossier (IMPD) processesProgram/Project ManagementLed or coordinated cross-functional teams (scientists, clinicians, regulatory, QA, manufacturing)Managed budgets, timelines, and risk mitigation plansWorked with internal and external stakeholders (biotech partners, CROs, CMOs)Key Competencies & SkillsLeadership & Strategy Vision to guide the program from lab to clinic (bench-to-bedside)Proven leadership of multidisciplinary teamsAbility to align scientific and clinical goals with institutional or business objectivesCommunication: Clear communicator with ability to: Write regulatory documents, and scientific publicationsPresent at internal reviews and scientific/clinical conferencesEngage with stakeholders (investors, regulators, collaborators) Management: Expertise in: Project planning tools Risk analysis and mitigationFinancial oversight and budgeting