• 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.
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• May serve as a single point of accountability to the business unit (BU) for design, execution, monitoring, delivery and reporting of one or more clinical studies.
• May serve in the role of a Clinical Lead.
• May supervise one or more clinicians in support of clinical programs.
Responsibilities
Clinical Development- including but not limited to:
• Leads clinical development strategy and program execution for significant elements of the project.
• Accountable for design, execution, monitoring and reporting of clinical programs, as well as individual clinical trials in role as study clinician (if applicable).
• 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.
• Leads the preparation of the clinical content of regulatory submissions/documents (e.g. NDA, MAA, IND, sNDA, IB, AR).
• Provides oversight of QC and submissions planning for multiple countries in the APAC, AfME, Eastern Europe, and LATAM regions.
• Responsible for planning and implementation of the EU Pediatric Investigation Plan.
• Maintains knowledge of competitor products and development plans.
• May organize expert panels as needed for input to clinical development programs.
• Accountable for development of clinical documents (e.g., protocol, clinical study reports, clinical components of regulatory submission). Will provide sign-off for documents generated by clinicians supervised.
• 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 function as line manager for other clinicians.
• 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; 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 and external advisory committees (e.g. TRC, advisory boards) on design of clinical trials and data from clinical trials.
• Provides clinical assistance regarding Scientific and Commercialization Support (SCS) for approved medicines, co-promotions, product defense, and clinical consultation on epidemiology and OR studies.
• 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: PhD, PharmD, DVM, or MS (or equivalent training/experience).
• Required: 10+ 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. Preferred experience in regulatory submissions.
• 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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