Clinical Development Medical Senior Director (MD Required

The Clinical Development Medical Senior Director is responsible for medical and scientific oversight, data integrity, and quality of clinical trials in Internal Medicine, with direct responsibility for clinical deliverables for one or more studies, leading and contributing to process improvement initiatives. They may also manage, supervise, and mentor others.

• Provides medical monitoring on one or more clinical trials:
• Provides timely, study-related medical information and guidance, e.g., on:
• Medical questions from investigator sites
• Medical issues in clinical trial data
• Medical findings in audits or inspections
• Contributes to medical assessments of Quality Events
• Conducts and documents periodic safety data review and ongoing clinical/medical data review
• Reviews Required Safety Text for the Informed Consent Document and significant medical changes in the Informed Consent Document
• May independently lead clinical execution of one or more studies; accountable for program level clinical deliverables
• Provides input to the protocol design document; leads development of the protocol, including protocol amendments, Protocol Administrative Change Letters, and Dear Investigator Letters
• Represents the study team in internal protocol review governance submissions and interactions; partners with/supports the Global Development Lead in study and disease area strategy; may participate in protocol-related KOL and Health Authority interactions
• Ensures development of Study Informed Consent Documents and responses to external stakeholder (e.g., Health Authority and Independent Ethics Committee) requests
• Provides clinical guidance to the development of the Statistical Analysis Plan and Tables, Listings, and Figures
• Provides clinical guidance to the development of the clinical data collection strategy, instruments, and data review plan, ensuring alignment with the protocol and SAP, optimized data collection principles, and clinical data review best practice; sets the clinical data review strategy and leads the team in the review of emerging clinical data and trends; reviews and queries data; presents data to internal and external stakeholders;
  
  partners with site-facing colleagues in support of data issue resolution; ensures all clinical queries are appropriately addressed in support of database lock
• Provides clinical guidance to the development of the Safety Review Plan and Safety Narrative Plan; reviews safety data and ensures clinical documents are updated in response to emerging safety profile; tracks and reconciles Serious Adverse Events; leads clinical safety data discussion during Safety Review Team meetings in collaboration with Medically Qualified Individual(s); reviews safety narratives
• Provides clinical guidance to the development of the Risk Management Plan; ensures clinical activities are consistent with the approved Plan and partners with key stakeholders to develop and implement risk mitigations
• Establishes and manages External Data Monitoring Committees and Adjudication Committees, including chartering, contracting, provision and presentation of data, and documentation and dissemination of Committee recommendations
• Develops site selection criteria, provides clinical input to selection of sites, and ensures protocol training is delivered to site-facing colleagues
• Participates in investigator meeting planning and develops and delivers protocol training; develops and delivers ongoing protocol training in response to e.g., protocol amendments, emerging data issues, and quality events
• Serves as the primary clinical point of contact with investigators and study team for questions relating to clinical aspects of the protocol; manages clinical response development, delivery, documentation, and curation (e.g., in FAQ)
• Ensures protocol deviation sub-categories are established; ensures protocol deviations identified during clinical data review are reported; ensures all reported protocol deviations are appropriately managed and reconciled; leads protocol deviation trends review
• Ensures TMF compliance for clinical documents
• Provides clinical input and review of the Clinical Study Report
• Ensures disclosure of safety and efficacy data and trial conclusions; may contribute to publications
• Provides clinical support to audits and inspections, including responding to and addressing audit and inspection findings
• May contribute to clinical sections of regulatory filings (e.g., Briefing Documents, Pediatric Investigational Plan, Investigator Brochure, IND/NDA Annual Reports, Periodic Safety Update Reports, responses to Health Authority requests)
• Leads the adoption and implementation of continuous improvement / process enhancement activities and innovative approaches to maximize effectiveness of clinical trial execution at the program and portfolio levels; contributes to enterprise-level initiatives
• May have managerial responsibility for other clinical colleagues or contingent workers; may supervise, mentor, or develop others