Director, Clinical Science

Working with the Medical Director(s), to create key strategic documents including clinical development plans, protocol concepts and full protocols across the 3 phases of clinical development. Contribute to the development of clinical sections of regulatory documents such as Investigators' Brochures, briefing books, safety updates, IND/NDA submission documents, responses to Health Authorities questions, and Clinical Development Plans (CDPs). Provide ongoing medical expertise and oversight of clinical trials across Phases 1-3 for trial conduct and safety. Provide strategic consultation and guidance to research on all decisions that have significant clinical components and implications. Provide essential evaluation of the development strategy to maintain a development plan that is consistent with the latest regulatory requirements, identification of challenges, and development of contingency plans to meet them Provide input into the design and conduct of clinical trials, review and/or generate key study documents (such as medical monitoring and safety management plans, treatment manuals, etc), Set up study steering committee to establish relationships with essential opinion leaders relevant to assigned compounds and therapeutic areas, clinical development programs and key clinical studies Assist in the recruitment of investigators for clinical studies and provide medical support to investigator meetings Provide protocol training, disease specific training and presentations at investigator meetings and protocol training meetings. Supports development of medical monitoring plan(s) and assists with reviews of clinical data in accordance with the Medical Monitoring Plan in cooperation with Medical Monitor, Data Management and Biostatistics Provides input to site selection and Coordinates feasibility studies - Assist in the study feasibility process by generating/reviewing feasibility questionnaires, identifying patient pathways, defining standard of care, and support site identification and selection. Performing medical data review during study execution to ensure integrity of accruing study data and appropriate safety follow-up. Set up and management of investigator initiated clinical and/or pre-clinical trials. Develop effective working relationship with key investigators in assigned programs to optimize scientific quality/innovation of clinical study design, execution, reporting and publication. Contribute to trial-related advisory boards. Coordinate the real time availability of quality clinical trial data, including safety, efficacy, pharmacokinetic and biomarker data, to provide consolidated information for dose escalation meetings and Phase II data reviews with investigators. Participate with ongoing medical review of clinical data and patient profiles, assessing issues related to protocol conduct, clinical data quality, and patient enrollment Provide medical leadership and scientific guidance to CROs and provides ongoing medical support to study team and investigators, including management of eligibility issues Evaluate safety, pharmacology, and efficacy in ongoing and completed studies in close collaboration with medical monitor, safety, and clinical operations teams Assist in the development and maintenance of standard documents regarding safety and medical monitoring processes and procedures including safety reports to Data Monitoring Committees. Participates in blinded/unblinded data review meetings and review of clinical study report Assist with the preparation, review and interpretation of data from ongoing studies, assessing the medical and scientific effects, and making recommendations that impact development such as "go/no go" decisions or modification of development plans or study designs that may have a significant impact on timelines or product labeling Assist the medical director for ensuring data quality, summary, and writing of clinical study report in close collaboration with the clinical operations, biometrics, and oversight of the CRO Prepare study data reviews to Management and help provide summaries of individual study results and how the results affect the compound strategy. Participate in all reviews and procedures required for database lock and review all patient narratives Assist with completion of clinical study reports (CSR) Stay abreast of guidelines, current trends and medical practice in the assigned therapeutic area, including reports and intelligence on key and critical new technologies or treatment advances Provide medical and scientific input to Health Economics & Outcomes Research (HEOR) studies, RWE studies and value dossiers for market access Assist with medical writing and publications (reviews, summaries, primary and secondary manuscripts) Minimum of a college degree in life sciences or nursing degree, advanced degree preferred (MD, PhD, PharmD or MS). The ideal candidate will have 8+ years in planning, executing, reporting and publishing clinical studies in a pharmaceutical company and/or contract research organization. Proven track record of successfully executing multiple proof of concept and pivotal trials: NDA submission and HA interactions experience is a plus. The candidate will have previous experience working on large (>4,000 patients) global, multinational cardiovascular outcomes trials. The skills required for success in the job include scientific and analytic ability, ability to think strategically and tactically, an interest in applied clinical research, ability to work effectively in multifunctional and multinational teams, as well as the ability to multitask and prioritize. Proven experience in developing effective relationships with key investigators. Experience in leading the team in a matrix setting.'