Senior Director, Clinical Program Leader (CPL) Genocea Biosciences, Inc.
We are seeking a dedicated professional to lead project from preclinical toxicology stage to phase 3 clinical trial. Responsible for continuity, compliance, budget and quality of leadership of the matrix project team.
Strong clinical management skills and significant understanding of project management tools. Previous experience in the field of vaccinology strongly desirable. In depth knowledge of GCPs and ICH Guidelines. Solid understanding of all aspects of clinical product development. Understand business implication of clinical stage development clinical trial design and execution. Excellent communication and presentation skills (both written and verbal), attention to detail, good organizational skills and proactive approach to problem solving.
PhD/ MD with at least 8 years hands-on experience in clinical research (i.e. responsible for trial document preparation, site management, study and team coordination).
Essential driver of overall vaccine development strategy
Accountable and responsible for planning, content, execution, and delivery of development strategy / plan to POC and for delivering program milestones in a timely, cost-effective, and quality fashion
Formulates clinical development strategies and plans as a leader of cross-functional clinical development team
Single point of accountability for synthesizing team positions
Gives presentations and leads discussion of data at review committees, other internal governance, external consultants, KOLs, and regulatory meetings as necessary
Attends, makes presentations and provides GCP/ICH/FDA regulations and SOP training at investigator meetings as appropriate and assures continuity and alignment with the trial objectives and overall clinical program throughout the trial
Authorship of publications and coordination of Data Monitoring Committee activities
Ensures application of innovative trial designs
Key contributor to clinical parts of regulatory dossiers and assists in the preparation of regulatory filings
Contributes to publication strategy and write-up of abstracts, posters and papers across clinical program
Analyzes clinical data
Maintains up to date knowledge of published literature in relevant therapeutic areas including the key development issues
Provides medical input to project teams and study teams
Can lead pivotal, complex or multi-regional clinical trials overseeing clinical project management
Prepares trial protocol, amendments and informed consent form, taking active part in study design in internal discussion/meetings
Ensures timely communication of key project information to appropriate stakeholders
Leads team, retains overall accountability for the clinical product including compliance, quality, budget tracking and timelines throughout the trial
Coordinates all central activities for the clinical trials
Maintains accurate and up-to-date information in project management systems and trial specific tracking systems
Management of overall timelines for clinical program
Manage direct reports to ensure the activities are completed as per the plan
When necessary, interfaces with regulatory, outcomes research, development operations and other members of extended project team(s) to ensure alignment / understanding of the plan and that line activities will support delivery of key milestones
Ensures alignment of all parties and addresses any issues in the implementation of development plans and strategies for assigned projects
Establishes relationships with key external experts, consultants, opinion leaders and regulators
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