Confidential (via Talento HR)
Bangalore, Karnataka · On-site · Full-time · 15-18 years experience
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Role summary
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.
Qualifications:
MD Pharmacology
MD Pathology
Experience in clinical research and complete knowledge of all global guidelines
Working Conditions:
Role Type: Full Time and Onsite
Work Hours: General Shift or Rotational Shift
Travel Requirements: Yes / travel (10%)
Key Responsibilities:
• 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.
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.
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.
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.
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.
Primary Objectives:
• Completion of patient enrolment in ongoing study and meet the timelines for regulatory submission
• CRO award for upcoming study and EC approvals and start of patient enrolment as per timelines
• Collaboration with RND for global development of new assets
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
• Strong analytical skills, with the ability to interpret and present complex clinical data
• Experience in clinical trials, teaching, training, public speaking, presenting papers & publications
Soft Skills:
Proactiveness
Interpersonal Skills 1- Persuasive
Interpersonal Skills 2- Ethical
Action Driven Skills / Decisive
Action Driven Skills / Resourceful
Intellectual Skills 1- Analytical
Intellectual Skills2- Problem solver
Motivational Skills 1- Committed
Motivational Skills 2- Initiative