Clinical Development Medical Senior Manager

The Clinical Development Medical Senior Manager is accountable for the: Medical & scientific integrity of the study and well-being of participants enrolled in one or more clinical trials. Timely delivery of high-quality protocols and clinical study execution. Clinical data, safety, risk review and mitigation. Use of AI-enabled clinical development and digital approaches to support excellence in clinical trial design and execution.

Provides input to support development of the protocol design document. Leads or supports development and timely delivery of a quality  protocol which maximizes operational efficiency, trial quality and participant / site engagement and minimizes the likelihood of amendments or quality issues. Provides clinical input to the DORA process to ensure application of data standards, optimized data collection, and timely and thorough data review using clinical data review best practice. Responsible for providing clinical input to the SAP, TLFs, and BDR. Manages  Informed Consent Documents (ICDs) as per SOP including responses to external stakeholder questions. Provides clinical input to development of the Integrated Quality Management Plan (IQMP) as per SOP. Supports establishment  and oversight of independent study committees, such as Data Monitoring Committees (DMCs) and endpoint adjudication committees, including chartering, contracts, provision of relevant data and documentation of outcomes. Inputs to, reviews, and approves the Risk Management and Safety Review Plan. Ensures activities are conducted consistent with the approved plan and partners with key stakeholders, including clinical operations and the safety risk lead, to develop and implement any risk mitigations. Reviews and approves country selection, develops site selection criteria and ensures protocol specific training. Approves investigator meeting plans. Serves as the primary contact with external investigators and internal study team for questions relating to medical or clinical aspects of protocol. Reviews, reports and manages protocol deviations and approves protocol amendments as per SOP. Proactively mitigates risk and manages emerging clinical issues through timely, diligent clinical data, safety, and protocol deviation review. Reviews patient level and cumulative data per the data review plan across one or more studies. Reviews safety data, SAE reports, TMEs, DMEs, and ICDs as required. Tracks and reconciles serious adverse events (SAEs) across a study and leads presentation of data during Safety Review Team meetings. Performs medical monitoring  for one or more clinical trials. Ensures Inspection Readiness for clinical documents. Supports appropriate interpretation and communication of clinical trial data. Inputs and reviews the Clinical Study Report including the review of narratives. Responsible for supporting disclosure of safety and efficacy data and trial conclusions. Contributes to primary publication of clinical trial results. Provides clinical support to the study team or clinical program in response to audits or inspections Supports clinical sections of regulatory filings, including the Pediatric Investigational Plan, Investigator Brochure (IB), IND/NDA Annual Reports, Periodic Safety Update Reports, and regulatory authority responses. May support responsible colleagues with the development of responses to regulatory queries and audit/inspection findings and Clinical Trial Applications (CTAs). Accountable for compliance with internal and external standards. Contributes to continuous improvement / process enhancement activities and innovative approaches to maximize effectiveness of clinical trial execution. Uses AI-enabled tools and analytics to support clinical data review, signal detection, and risk identification. Supports innovation, user feedback, and change adoption for digital clinical development tools. QUALIFICATIONS / SKILLS Education REQUIRED: MD or equivalent medical