Project Director Stem cell therapy project
Gurgaon, India
Permanent role
- Qualifications :
- PhD (minimum) in
- Stem cell biology
- Tissue engineering
- Biomedical Sciences
Or
MD 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 ofGood 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 & StrategyVision 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 toolsRisk analysis and mitigationFinancial oversight and budgetingSkills Required
biomedical sciences , tissue engineering , Program Project Management, Risk Mitigation