Clinical Development operations, Clinical trial management with CRO oversight, meeting the timelines for
patient recruitment, follow up and data management, aligning with go to market strategy. Site
management and presentations to regulatory agencies. Close collaboration with RND for pipeline
products and early development.
5. Key Responsibilities:
1. Clinical Development: Lead the design, execution, and management of clinical development
programs from early phase to late-stage trials, ensuring alignment with the organization s
strategic goals. Develop and execute clinical development plans for new therapies and products,
including protocol design, patient recruitment strategies, and study management. Work with
cross-functional teams (R&D;, regulatory, commercial) to integrate clinical insights into overall
development strategies. Ensure clinical trials meet regulatory standards (FDA, EMA, ICH-GCP)
and are conducted efficiently within budget and timelines. Provide medical and scientific
oversight for clinical trials, ensuring patient safety and scientific integrity. Lead the development
of medical strategies and communication plans to support product approvals and commercial
launches.
2. Clinical Operations Management/CRO Oversight: Oversee global clinical trials, including protocol
development, site selection, patient recruitment, and data analysis. Manage CROs, investigators,
third-party laboratories, and other stakeholders to ensure adherence to timelines and protocols.
Implement risk management strategies to address trial challenges and maintain successful trial
execution. Monitor clinical performance through audits, reviews, and feedback, ensuring




corrective actions are taken as necessary. Regulatory Compliance Safety: Collaborate with
regulatory affairs to support clinical trial applications (IND, CTA) and ensure compliance with
global regulatory requirements. Provide input on regulatory submissions, including clinical study
reports, safety reports, and product labeling. Monitor patient safety throughout clinical trials,
overseeing adverse event reporting and safety management procedures.
3. Regulatory Compliance Safety: Collaborate with regulatory affairs to support clinical trial
applications (IND, CTA) and ensure compliance with global regulatory requirements. Provide
input on regulatory submissions, including clinical study reports, safety reports, and product
labeling. Monitor patient safety throughout clinical trials, overseeing adverse event reporting
and safety management procedures. Interaction/presentation to regulatory authorities ,
government funding agencies , and decision makers to address queries and expediting the
registration process.
4. Team Leadership and Development: Lead and mentor the clinical development and operations
team, fostering a culture of scientific excellence, collaboration, and continuous improvement.
Ensure team members are trained in best practices for clinical development,



compliance, and

regulatory requirements. Promote innovation within the team, identifying opportunities for
process improvements and implementing best practices in clinical and medical operations.
5. Budget and Resource Management: Manage clinical and medical budgets, ensuring efficient
allocation of resources and cost-effective trial execution. Collaborate with finance and
operations teams to forecast clinical development costs and allocate resources accordingly.
6. Primary Objectives:
1. Completion of patient enrolment in ongoing study and meet the timelines for regulatory
submission
2. CRO award for upcoming study and EC approvals and start of patient enrolment as per timelines
3. Collaboration with RND for global development of new assets
7. Competencies Required:
Technical Competencies:
Strategic leadership and vision with the ability to drive clinical and medical strategies
Exceptional communication and stakeholder management skills
Expertise in clinical trial design, regulatory compliance, and safety monitoring
Ability to manage multiple projects simultaneously and work in a fast-paced, dynamic
environment
Robust analytical skills, with the ability to interpret and present complex clinical data
Experience in clinical trials, teaching, training, public speaking, presenting papers & publications

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 CDO _ Immuneel Therapeutics Professional (Bengaluru)
🏢 Gig Consultants
📍 Bengaluru