Project Director
4 days ago
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
 
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