Massachusetts Jobs

Job ID REQ-10022402 Key Responsibilities: Study Leader and/or Clinical Scientist for predominantly high complexity, global studies. May function as a Core Project Team member for assigned projects to drive the Research-Development-Commercial (RDC) continuum. May co-lead project clinical sub-team and reports study/project progress and issues with their resolution plan to project teams and stakeholders. Directs early stages of study design and operational plans. Lead a global cross functional Clinical Trial Team (CTT) to ensure all trial deliverables are met; sets stretch goals, promotes realistic planning and timelines, and presents actionable alternatives to accelerate timelines. Proactively lead risk mitigation discussions, risk management and implementation at the trial level. Responsible and accountable for forecasting and managing overall study budget(s) in collaboration with key partners. Lead development of strategic and scientific input into study concept, feasibility, and ability to execute; develops and implements study-level operational execution plan in partnership with key cross functional partners, if applicable. Independently lead the clinical protocol development process in collaboration with the Medical Lead and other line functions; responsible author for clinical protocols, amendments, etc.; contribute to the medical/scientific input given for the development of study-related documents and processes which resides in other line functions; contribute to the development of clinical sections of study-level regulatory documents. May provide clinical leadership and strategic input for all clinical deliverables across assigned indication/program or studies within Biomedical Research. Lead the ongoing medical/scientific review of clinical trial data across assigned studies in collaboration with the medical expert and key line functions, and partners on data analysis and data interpretation, including safety trend analysis, signal detection, development of first interpretable results, reporting clinical study results in Clinical Study Report (CSR), and internal/external publications. Prepare and lead dose escalation meetings with investigators. Coordinate the real time availability of quality clinical trial data, to provide consolidated information for dose escalation meetings and Phase II data reviews with relevant stakeholders. Responsible for implementation of best practices and standards for trial management, including sharing lessons learned. Represent group on initiatives; may serve as Subject Matter Expert. Essential Requirements: This position will be located at either the Cambridge, MA or the East Hanover, NJ site and will not have the ability to be located remotely. This position will require 0-5% travel as defined by the business (domestic and/ or international). Bachelors in life science/healthcare required; Advanced degree or equivalent education/degree in life sciences/ healthcare preferred (PhD/MD/ PharmD/ Masters). Approximately 8+ years? experience in clinical trials/development with 3+ years leading cross-functional teams. Ability to lead multiple complex clinical trials concurrently. Strong understanding of oncology/hematology and demonstrates high learning agility. Proficient in clinical trial methodology with an emphasis in early clinical development. Strong operational project and program management experience with an emphasis in early clinical development, including excellent planning, prioritization, problem solving and organizational skills. Demonstrated capability to interpret, discuss and represent trial level data. Demonstrated knowledge and ability to confidently drive complex collaborations through unpredictable circumstances and higher paced changes. Demonstrate strong tolerance for ambiguity, willingness to adapt, and willingness to speak-up and challenge.