Associate Director, Clinician

Clinical Trials

• Co-chairs clinical study team and works collaboratively with other study team members.
• Point of accountability to the BU for design, conduct, interpretation and reporting of one or more clinical studies (or elements of those studies).
• Provides clinical and scientific expertise to the clinical trial strategy and protocol development process, including acquisition of knowledge of competitor products.
• Through application of Enhanced Clinical Trial Design (ECTD) / Enhanced Quantitative Drug Development (EQDD), ensures the most efficient clinical protocols are developed.
• Designs/writes clinical trial outlines, protocols and amendments, in collaboration with internal contributors (e.g. statisticians, Outcomes Research (OR) specialists, clinical pharmacologists, clinical project managers, Regional Clinical Site Leads (RCSLs), market access colleagues, commercial development colleagues), internal experts (e.g. clinical program lead, global clinical lead, global clinical strategy lead), and external experts (e.g. investigators, key opinion leaders, advisory board members); ensures design is consistent with objectives.
• Proactively authors efficient protocols that minimize the likelihood of amendments.
• Identifies and assesses study risks to Good Clinical Practices, subject rights/safety and data integrity throughout protocol development and study conduct; creates, implements and assesses effectiveness of mitigation plans.
• Provides clinical input to the Study Team for monitoring guidelines, iqRAMP, statistical analysis plans, informed consent documents, clinical review forms, data edit checks, data quality planning, and Regional Medical Monitor – Medical Oversight Plan as needed; ultimately oversees work of the Study Team.
• Contributes to CRO / vendor selection to ensure studies are conducted consistent with protocol requirements, clinical plan expectations and study timelines, including ensuring medical/technical requirements for data integrity (e.g. lab specifications).
• Approves selection of countries, clinical sites and investigators with appropriate qualifications, patient populations and recruitment strategy to meet study goals in a timely, high-quality and cost-effective manner.
• Ensures studies are registered on www.clinicaltrials.gov, study details are kept up to date and basic results are disclosed as required.
• Creates (and where appropriate, delivers) clinical/protocol training materials for study and site management, site initiation visits and investigator meetings.
• Helps establish and oversees Data Monitoring Committees (DMCs) and endpoint adjudication committees, including chartering, contracts, provision of relevant data and documentation of outcomes.
• Jointly accountable with the study team for study enrollment and adherence to agreed timelines for study deliverables.
• Maintains direct contact with investigative sites through site visits, telephone contacts and email to facilitate investigator engagement, address protocol or investigational product questions and support enrollment activities; works in conjunction with RCSLs when assigned.
• Consistent with the Safety Review Plan (SRP), performs and documents regular review of individual subject safety data and cumulative safety data with the safety risk lead; all safety review is performed in consultation with a medically qualified Medical Monitor.
• Identifies emerging safety trends and escalates for further discussion with the Clinical Program Lead and/or Global Clinical Lead; follows up with investigators for specific safety findings (e.g. SAEs).
• Reviews and manages protocol deviations.
• Works with the study team to ensure high quality of data during study conduct (e.g. appropriate patient population, adequacy of clinical assessments).
• Conducts clinical review and interpretation of efficacy and safety data, including delivery of top-line reports with statisticians and clinical study reports with medical writers; accountable for quality and timeliness of analysis and reporting.
• Responsible for the clinical and scientific validity of study reports, especially conclusions regarding efficacy and safety, and for appropriate disclosure of safety and efficacy data.
• Ensures narrative strategy for clinical trials is consistent with program narrative strategy; writes or oversees writing of safety narratives.
• Assists in ensuring regulatory compliance for clinical trials and reporting; contributes to primary publication of clinical trial results.
• Acts as primary contact with external investigators and internal study teams for clinical/medical protocol questions as needed.
• Keeps the Development China Clinical Program Lead and/or Category Development Lead informed of critical issues related to benefit-risk evaluation or study delivery (budget, timelines, quality).
• Presents to internal and external advisory committees on clinical trial design and data.