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Project Director

Project Director

ConfidentialGurgaon / Gurugram, India
17 days ago
Job description

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 certification
  • Experience & Skill set required :
  • 8-10 years + experience in stem cell or regenerative medicine research
  • Knowledge of
  • Good Manufacturing Practices (GMP)
  • Good Lab Practice (GLP)
  • Cell therapy product development
  • Designing &managing preclinical (animal studies)
  • Exposure / Experience in phase1 / II clinical trials
  • Working with Institutional Review Boards (IRBs) and ethics committees
  • Understanding of clinical trial protocols, patient safety, and informed consent
  • Regulatory & Compliance Knowledge :
  • FDA and EMA regulatory frameworks for cell and gene therapies
  • Investigational New Drug (IND) or Investigational Medicinal Product Dossier (IMPD) processes
  • Program / Project Management
  • Led or coordinated cross-functional teams (scientists, clinicians, regulatory, QA, manufacturing)
  • Managed budgets, timelines, and risk mitigation plans
  • Worked with internal and external stakeholders (biotech partners, CROs, CMOs)
  • Key Competencies & Skills
  • Leadership & Strategy
  • Vision to guide the program from lab to clinic (bench-to-bedside)
  • Proven leadership of multidisciplinary teams
  • Ability to align scientific and clinical goals with institutional or business objectives
  • Communication : Clear communicator with ability to :
  • Write regulatory documents, and scientific publications
  • Present at internal reviews and scientific / clinical conferences
  • Engage with stakeholders (investors, regulators, collaborators)
  • Management : Expertise in :
  • Project planning tools
  • Risk analysis and mitigation
  • Financial oversight and budgeting
  • Skills Required

    biomedical sciences , tissue engineering , Program Project Management, Risk Mitigation

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    Director • Gurgaon / Gurugram, India

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