Significant contributor to clinical trial design and execution for anti-infectives, integrating scientific and clinical expertise, efficient and cost effective clinical trial design, innovation, and operational excellence to address program level needs.
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• Performs clinical trial safety review in role of Physician-Clinician (medical monitor)
• Assures that clinical trial objectives fit with the clinical program strategy.
Responsibilities
• Significant contributor to clinical trial design and execution for anti-infectives, integrating scientific and clinical expertise, efficient and cost effective clinical trial design, innovation, and operational excellence to address program level needs.
• This role will ensure that appropriate clinical and scientific expertise is an integral part of the clinical trial strategy and clinical program execution
.
• Performs clinical trial safety review in role of Physician-Clinician (medical monitor)
• Assures that clinical trial objectives fit with the clinical program strategy.
ROLE RESPONSIBILITIES
In order of importance, indicate the primary responsibilities critical to the performance of the role. It is recommended not to list actual tasks but focus on 5-8 essential responsibilities that highlight accountability and level of judgment required.
Clinical Development- including but not limited to:
• Accountable for design, execution, monitoring and reporting of clinical programs, as well as individual clinical trials in role as study clinician (if applicable).
• Provides medical input/serves as a key contributor to the clinical development strategy; responsible for program execution for significant elements of the project.
• Ensures clinical, scientific and technical excellence in the team.
• Collaboration in matrix environment/relationships with colleagues in other disciplines supporting the clinical program (i.e., statistics, clinical pharmacology, outcomes research, clinical program managers, etc.).
• Authors clinical plans or significant elements of the clinical plan.
• Maintains knowledge of competitor products and development plans.
• Accountable for developing and providing medical input into clinical documents (e.g., protocol, clinical study reports, clinical components of regulatory submission). Will provide sign-off for documents generated by any clinicians supervised.
• Provides medical input and leads or assists in the preparation of the clinical content of regulatory submissions/documents.
• Plans resources required for elements of project under his/her responsibility.
• May present to senior management, governance committees, and external audiences on milestones, strategies, or data as appropriate.
• May design/write clinical trial outlines, in collaboration with internal contributors (e.g. statisticians, OR specialists, clinical pharmacologists, clinical project managers, market access colleagues, commercial development colleagues), internal experts (e.g. clinical disease area expert), and external experts (e.g. investigators, key opinion leaders, advisory board members); ensures design is consistent with objectives.
• Contributes to CRO / vendor selection to ensure study is conducted consistent with protocol requirements, clinical plan expectations, and study timelines; this includes ensuring technical requirements for data integrity are applied (e.g. lab specifications).
• Oversees study management staff in identification, evaluation and selection of countries and clinical sites and investigators with appropriate qualifications, patient populations, and recruitment strategy to meet goals in a timely, high quality and cost effective manner.
• Contributes to (and may oversee) clinical trial safety by performing safety review and analysis of pre-market and/or post-market trials and tracking emerging efficacy and safety profile of drugs consistent with Safety Review Plan in the role of medical monitor; responsible for identifying emerging safety trends and raising them forward for further discussion with the Clinical sub-team and/or medical development team.
• Assists in ensuring regulatory compliance for clinical trials and reporting.
• Presents to internal advisory committees (e.g. TRC, advisory boards) on design of clinical trials and data from clinical trials.
• Assists in the preparation of the clinical content of regulatory submissions/documents (e.g. NDA, MAA, IND, sNDA, IB, AR).
• Leads or assists in the development of publications, abstracts, presentations.
Consistent with SRP, performs and documents regular review of individual subject safety data and performs review of cumulative safety data with the safety risk lead (as delegated by the clinical lead). The specific components of safety data review are detailed in the Safety Data Review Guide.
General
• Coaches and mentors less experienced clinicians.
• Maintains and enhances knowledge in relevant disease area and/or technical area and practice guidelines relevant to the regions in which clinical trials are being conducted.
• Facilitates sharing of information on technical or operational best practices and lessons learned across Clinical Affairs.
Qualifications
• Training and Education: MD, DO or equivalent
• Required: 5-8 years expertise in Phase 2-4 clinical development in the pharmaceutical industry, practical experience in clinical trial strategies, methods and processes.
• Track record of achievement in pharmaceutical development, with a preference for exposure in anti-infectives.
• Able to independently formulate and execute clinical development plans or lifecycle strategy. Ability to integrate complex information.
• Demonstrated ability in the design, initiation and reporting of clinical studies as part of an integrated clinical plan.
• Ability to discuss scientific aspects of drug development, also comfortable in discussing commercial and regulatory issues.
• Able to review, evaluate, interpret and present complex data; understand the emerging safety and efficacy profile of the drug candidate including providing a perspective with comparator agents.
• Excellent verbal and written communication skills including scientific writing skills; includes strong inter-personal skills.
• Able to set priorities and manage cross-functional teams and complex projects to deliver milestones according to set budgets.
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