Project Director
1 day 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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