Director – Clinical Research

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