Director, Clinical Operations EnVivo Pharmaceuticals
THIS JOB HAS EXPIRED Position Summary
The Director Operations merges in-depth clinical and scientific expertise with broad operational knowledge to develop effective and innovative Clinical Development Plans (CDP) in close collaboration with Medical Research and other functions. The Operations Lead establishes program level operational strategy in support of the CDP for one or more clinical studies/program.
Takes a broad, strategic leadership role in ensuring the successful development of drug candidates in partnership with Medical Research and other functions.
Roles and Responsibilities
? Utilizes operational expertise, knowledge of TA strategy, and scientific assessment to evaluate program feasibility, assess end point measurement options, and ensure the successful execution of Clinical Studies. Reaches out to the Clinical Operations Management (COM) and Clinical Country Management (CCM) groups for phase and country expertise to inform CDP options.
? Leverage knowledge to influence the execution of CDPs and champions changes, when appropriate. Establishes performance goals and metrics, endorsed by the Program Executive, and ensures delivery.
Sets high level operational strategy and ensures implementation of clinical studies/program through influencing and supporting a matrix team.
? Accountable for the delivery (quality, time, budget) of clinical studies from an operational perspective.
? Identifies aspects of clinical studies/program with relevant touch points with other programs and ensures collaboration to optimize clinical trial execution.
? Supports the Clinical Operations Leads in the development of robust study concepts and protocols ensuring alignment with the CDP. Endorses study level operational plans to confirm alignment with CDP.
? Collaborates across programs to ensure interdisciplinary learnings are communicated and incorporated.
? Accountable for the clinical budget and works with Clinical Business Planning/Finance on long range planning, annual operating planning, and quarterly forecasting. Communicates study status, issues, and mitigations to relevant stakeholders.
? Empowers the Study Management Team by ensuring that Study Management Teams are provided with autonomy to create and implement strategic study plans and resolve study issues; maintains strong communication with Study Management Teams to ensure COLs and other study level functions have the needed program information to inform study plans and execution.
? Educates the Study Management Teams including relevant CRO personnel on the CDP and other factors that impact Study Management Team effectiveness.
? Responsible for ongoing communication of clinical studies/program status including issues and mitigation strategies.
? Effectively works in a matrix environment and is able to influence without authority.
? Presents program status and strategies to senior management.
? May participate in business development evaluations from the clinical research and operations perspective.
? Collaborates with Medical Research, Biostatistics, Safety, and other functions to ensure robust plans for clinical trials/program level data review including trend evaluation.
? Minimum of 5 years global drug development experience with deep clinical research and operational strategy experience including responsibility ensuring studies and programs are executed to quality, timelines and budget. NDA/MAA experience is desirable. Substantial global operational experience including a thorough knowledge of ICH GCP and regulatory requirements for clinical development.
? Excellent project management skills including risk assessment and contingency planning. Also requires excellent team leadership, communication, management and organizational skills, along with problem solving, conflict resolution, and team building skills. Proven effectiveness with cross-functional teams and matrix structures.
? Advanced science degree or equivalent experience. Strong scientific and analytical skills with demonstrated deep understanding of disease areas and learning agility that can be applied to multiple therapeutic areas. Scientifically and clinically astute (for relevant disease and more broadly within a therapeutic area); working knowledge of statistical concepts.
||Watertown, MA |
THIS JOB HAS EXPIRED