Director – Clinical Research

Job Description

Job Title: Director – Clinical Research Location: Greater Noida Experience Required: 5–10 Years in Clinical Research Educational Qualification: Ph.D., MD, or MPH (or equivalent) in a relevant scientific discipline (e.g., Biology, Medicine, Pharmacy) Budgeted CTC: Upto ₹36 LPA Employment Type: Full-Time | Onsite About the University: Our Client is a NAAC A+ accredited, multidisciplinary university in Greater Noida that fosters global learning, cutting-edge research, and innovation. With over 20,000 students from 85+ countries, the university is one of India’s leading education providers with a focus on holistic and interdisciplinary education. Position Overview: We are seeking a highly qualified and experienced Director – Clinical Research to lead and oversee clinical trials and research initiatives within our organization. The ideal candidate will have strong expertise in clinical research, particularly in oncology , and possess a deep understanding of global clinical trial regulations, study design, and execution. This role requires strategic thinking, team leadership, and the ability to manage multiple concurrent research projects in a fast-paced environment. Key Responsibilities: Leadership & Strategy: Lead and oversee all clinical research activities, ensuring alignment with organizational goals and regulatory requirements. Develop and implement clinical trial strategies, including protocol design, study planning, and risk mitigation. Provide mentorship and guidance to clinical research teams and collaborators. Clinical Trial Management: Oversee the planning, initiation, execution, and close-out of clinical trials. Ensure compliance with FDA regulations, ICH GCP guidelines, and applicable local regulations. Coordinate with CROs, investigators, and site staff for study implementation and monitoring. Regulatory & Compliance: Prepare and review clinical protocols, Investigator Brochures (IBs), informed consent forms, and regulatory submissions. Ensure ethical and regulatory compliance throughout all research activities. Data Analysis & Reporting: Collaborate with biostatisticians and data managers to analyze clinical data. Interpret study results and oversee preparation of study reports, publications, and regulatory documentation. Stakeholder Engagement: Liaise with cross-functional departments including medical affairs, pharmacovigilance, and R&D. Represent the organization in scientific meetings, regulatory discussions, and industry forums. Desired Candidate Profile: Educational Background: Ph.D., MD, or MPH in a relevant scientific field such as biology, medicine, pharmacology, pharmacy, or public health. Experience: Minimum 5–10 years of progressive experience in clinical research, with a strong track record in managing trials from concept to completion. Prior experience in oncology research is highly preferred. Experience working with global clinical trial regulations, particularly FDA and ICH GCP. Skills & Knowledge: Excellent knowledge of clinical trial design, regulatory pathways, and protocol development. Proficiency in statistical software (e.g., SAS, SPSS, R), data management tools (e.g., Medidata, Oracle Clinical), and relevant e-clinical systems. Strong communication, leadership, and problem-solving skills. Ability to work collaboratively in a cross-functional environment. Key Competencies: Strategic thinking and project leadership Clinical compliance and operational excellence Scientific acumen and data interpretation Team mentoring and stakeholder management Attention to ethical and quality standards Application Process: Interested candidates may send their updated CV and a brief statement of clinical leadership experience to: [connect@coral-ridge.com] | Subject Line: Application for Director – Clinical Research Shortlisted candidates will be contacted for an in-depth discussion and final round of interaction. Job Types: Full-time, Permanent Pay: ₹3,000,000.00 - ₹4,000,000.00 per year