Project Director

Project Director Stem cell therapy project

Gurgaon, India

Permanent role

• Qualifications:
• PhD (minimum) in
• Stem cell biology
• Tissue engineering
• Biomedical Sciences
  

• 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