Denovo Bioinnovations is a deep-tech, R&D-driven; medical technology company focused on developing next-generation surgical instruments and advanced robotic-assisted solutions to transform minimally invasive surgery. As we advance towards clinical validation and commercialisation, we are looking for an experienced clinical research professional to lead our Clinical Research & Clinical Affairs function, establish strategic relationships with leading surgeons and healthcare institutions, and drive clinical evidence generation for our innovative surgical technologies. Position: Lead – Clinical Research & Clinical AffairsLocation: Pune, Maharashtra Employment Type: Full-time Reporting To: Founder & CEO

Key Responsibilities
1. Clinical Research & Clinical Investigation
• Lead the planning, execution and management of clinical investigations for Denovo's medical device portfolio.
• Develop clinical investigation strategies, protocols, study designs, endpoints and clinical evaluation plans in collaboration with Principal Investigators and clinical experts.
• Coordinate clinical studies, pilot validations, multicentric investigations and post-market clinical follow-up, as applicable.
• Manage clinical trial documentation, regulatory submissions support, ethics committee approvals and institutional permissions in coordination with the Regulatory Affairs team.
• Ensure compliance with applicable ICH-GCP, ISO 14155, CDSCO requirements and institutional research policies.
• Oversee patient recruitment, site initiation, monitoring, data collection, clinical documentation and study closure.
• Coordinate with Clinical Research Organisations (CROs), hospitals, research institutions and clinical investigators.
• Ensure data integrity, patient safety, protocol compliance and timely completion of clinical milestones. 2. KOL Management & Surgeon Engagement
• Identify, develop and manage relationships with leading surgeons, Key Opinion Leaders (KOLs), HODs and clinical experts across relevant surgical specialties.
• Establish and strengthen collaborations with leading hospitals, medical colleges and clinical research institutions.
• Build a robust network of surgeons in laparoscopic surgery, general surgery, gastrointestinal surgery, gynaecology and other relevant specialties.
• Organise surgeon advisory meetings, clinical workshops, product demonstrations and expert consultations.
• Engage surgeons for product evaluation, clinical feedback, usability assessments and clinical validation programmes.
• Develop long-term relationships with clinical investigators and strategic medical advisors.
• Represent Denovo in relevant medical conferences, surgical workshops and clinical research forums. 3. Clinical Partnerships & Institutional Collaborations
• Develop and manage clinical research partnerships with leading hospitals, medical colleges and research institutions.




• Coordinate ongoing and prospective clinical collaborations with institutions such as AIIMS and other leading healthcare centres.
• Manage relationships with Principal Investigators, Co-investigators, research coordinators and hospital administration.
• Identify opportunities for collaborative research, investigator-initiated studies and multicentric clinical investigations.
• Facilitate institutional agreements, clinical study agreements, budgets and project timelines. 4. Clinical Operations & Team Management
• Build and lead the Clinical Research team, including Clinical Research Associates, Clinical Project Coordinators and Clinical Specialists.
• Develop clinical research SOPs, workflows, monitoring plans and documentation systems.
• Establish clinical project timelines, budgets, resource allocation and performance indicators.
• Monitor study progress, identify operational bottlenecks and ensure timely execution of clinical milestones.
• Manage CROs, clinical research vendors and external clinical consultants.
• Ensure effective coordination between Clinical Affairs, Regulatory Affairs, R&D;, Product Development and Business Development teams. 5. Clinical Evidence Generation & Scientific Communication
• Drive the development of clinical evidence supporting the safety, performance and effectiveness of Denovo's surgical devices.
• Coordinate clinical data analysis, clinical study reports, scientific publications and conference presentations.
• Develop clinical evaluation reports and support clinical evidence requirements in coordination with Regulatory Affairs.
• Translate clinical feedback and surgical workflow requirements into actionable inputs for product development.
• Establish mechanisms for continuous clinical feedback and product improvement. 6. Surgeon Training & Medical Education
• Develop surgeon training programmes for LapSure™, SutureSure™ and FlexiSure™.
• Coordinate cadaveric workshops, hands-on surgical training and product familiarisation programmes.
• Support the development of clinical demonstration protocols and training materials.
• Facilitate surgeon onboarding and clinical product evaluation programmes. Desired Candidate ProfileEducational

Qualifications:
• MBBS / MD / BDS / MDS.
• Master's degree in Clinical Research, Life Sciences, Biotechnology, Biomedical Sciences, Pharmacy or a related discipline.
• Candidates with relevant postgraduate qualifications or certifications in Clinical Research, Clinical Trials or Clinical Affairs will be preferred. Experience &





Skills:
• 7–12 years of experience in clinical research, clinical operations or clinical affairs, preferably in the medical device industry.
• Strong experience in managing clinical investigations and working with hospitals, Principal Investigators and clinical research teams.
• Proven experience in KOL management, surgeon engagement and institutional collaborations.
• Working knowledge of ICH-GCP, ISO 14155, CDSCO clinical investigation requirements and applicable clinical research regulations.
• Experience in clinical protocol development, study monitoring, clinical documentation, data management and clinical study reporting.
• Experience managing CROs, clinical investigators and multicentric clinical studies.
• Prior experience with surgical instruments, laparoscopic devices, minimally invasive surgery or electromechanical medical devices will be a significant advantage.
• Excellent communication, stakeholder management, project management and leadership skills.
• Willingness to travel for hospital visits, clinical site management, surgeon meetings and medical conferences. Preferred Candidate Background:
• Medical professionals (MBBS/MD/BDS/MDS) with experience in clinical research, clinical investigations or medical device clinical affairs.
• Professionals with experience in surgical device companies, CROs, academic medical institutions or hospital-based clinical research.
• Candidates with established relationships with surgeons, HODs, Principal Investigators and clinical institutions. What We Are Looking ForWe are looking for a proactive clinical leader who can independently establish and scale Denovo's Clinical Affairs function. The ideal candidate should be equally comfortable managing clinical investigations, building relationships with senior surgeons, coordinating with leading medical institutions and developing a strong clinical research team. This is a leadership opportunity for someone who wants to contribute directly to the clinical validation and adoption of innovative surgical technologies. Why Join Denovo?
• Opportunity to work on innovative, IP-backed surgical medical technologies.
• Direct involvement in clinical validation of next-generation laparoscopic and surgical devices.
• Opportunity to build and lead the Clinical Research & Clinical Affairs function.
• Work closely with leading surgeons, KOLs, Principal Investigators and premier medical institutions.
• Contribute to clinical research, scientific publications and global medical technology development.
• Be part of a growing deep-tech medtech company with global ambitions.
• Interested candidates can share their updated CV at [email protected] with the subject line: "Application – Lead Clinical Research & Clinical Affairs". Join Denovo Bioinnovations and help transform the future of surgical care.

📌 Lead – Clinical Research (Pune)
🏢 Denovo Bioinnovations Private
📍 Pune