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Careers

Innovation is the driving force behind our pursuit of better healthcare. We are a collective of scientists, experts, and innovators who challenge conventional thinking, embrace bold ideas, and turn scientific possibilities into breakthrough outcomes. Guided by a shared purpose, we are committed to advancing healthcare and creating solutions that bring transformational change in our healthcare outcomes.

We are committed to fostering a culture built on a growth mindset, diversity and inclusion, curiosity, and a genuine desire to make a difference. We encourage continuous learning, active listening, openness to new ideas, and the courage to embrace change. We empower our people with the freedom to innovate, collaborate, and turn possibilities into meaningful impact.

Assistant General Manager (AGM) – Clinical Research
JD# ILS/JBD/CRD/01-26

  • Assistant General Manager (AGM) – Clinical Research

    The AGM – Clinical Research is a critical leadership role responsible for the design, implementation and medical oversight of the company’s clinical development programmes. The role serves as the primary clinical link between the internal R&D team and external clinical partners (CROs, investigators, KOLs).


    The position is required to convert preclinical R&D outputs into clinical concepts, author First-in-Human (FIH) and later-phase protocols, provide ongoing medical monitoring, and lead the clinical components of IND / Clinical Trial Application dossiers and regulatory submissions to CDSCO/DCGI, so that products can progress into and through clinical trials safely, compliantly and on schedule.

  • Clinical Protocol & Concept Development

    •  Lead the design and development of robust clinical trial protocols (Phase I–III), aligned with the Clinical Development Plan (CDP) and scientific strategy.

    •  Translate preclinical R&D data into actionable clinical concepts and trial designs, including FIH studies.

    •  Co-author or review and finalise core clinical documents: Investigator’s Brochure (IB), Informed Consent Forms (ICF) and Clinical Study Reports (CSR).

    Medical Monitoring & Trial Oversight

    • Provide continuous medical monitoring and scientific oversight of ongoing trials to safeguard participant safety, data integrity and protocol compliance.

    • Oversee compliance of Sponsor responsibilities for safety management of participants including SAE management as per applicable regulations.

    • Perform targeted reviews of clinical trial data and resolve complex medical and scientific queries raised by study sites.

    Regulatory & IND Dossier Filing

    •  Work cross-functionally with R&D, Preclinical and Regulatory Affairs to co-compile, review and submit IND dossiers and Clinical Trial Applications (CTA).

    •  Provide strategic clinical input to regulatory documents, including responses to DCGI/CDSCO and Subject Expert Committee (SEC) queries.

    •  Ensure all clinical development activities adhere to ICH-GCP, applicable local regulations and internal SOPs.

    CRO & External Stakeholder Engagement

    •  Engage, evaluate and manage CROs and vendors, ensuring adherence to scope, quality standards and timelines.

    •  Act as the primary medical liaison with CRO Medical Monitors, Principal Investigators and KOLs to drive enrolment and address clinical escalations.

    •  Represent Immunoscript Life Science at investigator meetings together with the CRO.

  • •  Clinical trial design and methodology for Phase I–III studies, including FIH / early-phase design, dose selection and safety-stopping rules.

    •  Hands-on authoring of clinical protocols, IBs, ICFs and CSRs.

    •  Medical monitoring: AE/SAE assessment, causality review, safety data review and DSMB/SRC interaction.

    •  Working knowledge of ICH-GCP (E6), New Drugs and Clinical Trials Rules 2019, CDSCO/DCGI processes, and awareness of FDA and EMA frameworks.

    •  Experience preparing clinical sections of IND / CTA dossiers and responding to regulator queries.

    •  CRO selection, oversight and vendor management (scope, budgets, quality and timelines).

    •  Strong scientific/medical writing and data-interpretation skills.

  • •  Prior experience in vaccine clinical trials (immunogenicity endpoints, reactogenicity assessment, lot-to-lot consistency or challenge studies).

    •  Exposure to novel platforms such as mRNA/LNP vaccines or other biologics.

    •  Experience presenting at CDSCO Subject Expert Committee (SEC) meetings.

    •  Familiarity with CTRI registration, ethics committee submissions and pharmacovigilance reporting timelines.

    •  Working knowledge of biostatistics, sample-size estimation and EDC/CDMS systems.

  • •  Required: Bachelor of Medicine, Bachelor of Surgery (MBBS) from a recognised institution, with valid medical registration.

    •  Preferred: Doctor of Medicine (MD) –

    •  Current ICH-GCP training certification.

Please write to us with a detailed resumé to careers@immunoscript.bio

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