Director, Clinical Science

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. Collaborates with Medical Safety and Pharmacovigilance on the Safety Review Plan and Safety Narrative Plan; reviews safety data and ensures clinical documents are updated in response to emerging safety profile; 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 Collaborates with the medical monitor on establishing and managing External Data Monitoring Committees and Adjudication Committees, including chartering, data provision and presentation of data, and documentation and dissemination of Committee recommendations, as appropriate 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 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 primary publications Provides clinical support to audits and inspections, including responding to and addressing audit and inspection findings Contributes to continuous improvement / process enhancement activities and innovative approaches to maximize effectiveness of clinical trial execution Minimum of a college degree in life sciences or nursing degree, advanced degree preferred (i.e. PhD, PharmD or MS) with 10+ years of experience in the pharmaceutical/biotech industry The candidate will have previous experience working on complex trials in the area of non-malignant hematology and/or rare disease Proven track record of successfully executing multiple proof of concept and pivotal trials; (s)NDA submission and HA interactions experience is a plus 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.

Biopharmaceutical company pioneering RNA interference (RNAi) therapeutics for rare genetic, cardiometabolic, and CNS diseases. Headquartered in Cambridge, MA.

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