The successful candidate will be responsible for leading a multi-function team through the clinical development of a novel T-cell based vaccine. The Clinical Program Leader (CPL) will, along with the Genocea leadership, establish the objectives for the clinical phase of the product development. The CPL will work with other functions, including manufacturing, regulatory, research, statistics, commercial and clinical operations, in a matrixed project team, to achieve the objectives. This is a high-visibility leadership position and includes identifying and forging internal and external partnerships to advance the project objectives.
- Experience in and strong understanding of clinical development of drug and/or biologic therapeutics
- Demonstrated ability to lead a multi-function team within a matrix environment toward successful completion of project objectives
- Organizational and communication skills to effectively articulate objectives, progress, and risks to Executive and Project Team members
- Demonstrated problem solving capabilities, and ability to think creatively to efficiently identify and utilize required resources
- Familiarity with regulatory requirements and ICH guidelines for development of new therapies
- Solid understanding of all aspects of clinical product development, clinical trial design, and execution
- Demonstrated ability to establish professional relationships with investigators and clinical trial site personnel to assure efficient conduct of clinical trials in compliance with GCP standards
- Previous experience in the field of vaccines, immunology, infectious diseases or oncology is strongly desirable
CLINICAL PROGRAM LEADER RESPONSIBILITIES
- Collaboratively develop clinical program objectives with Project Leader and in agreement with corporate goals and overall Product Development Objectives
- Lead the multi-function Product Development Team: reaching agreement on the Product Development Plan, execution of the Plan; and communicate to the Executive Team
- Develop and agree with Project Leader the product development budget, milestones and timelines for the execution of the Clinical Program. Communicate output to Executive Team
- Works with Project Team members to harmonize the Clinical Program with the overall Product Development Plan
- Works with Project Manager and Clinical Operations to assure effective conduct of clinical trials, on budget and on time, according to GCP and regulatory requirements
- Prepares or oversees writing of clinical trial protocols and related documents to assure consistency with Project objectives, and sound scientific principles and integrity
- Works with the Project Leader and key members of the Project Team to review, analyze and synthesize real time clinical data to understand the implications for the Plan and make adjustments accordingly; informing and seeking input from the Executive Team as appropriate
- Works with Medical Communications and other stakeholders (including Commercial) to develop publication strategies, presentations for scientific meetings, publications, etc.
- Give presentations and lead discussions of data at internal meetings including Project Team, Executive Review meetings. Also may present to external audiences including consultants, KOLs, investigators, and regulatory meetings as necessary
- Key contributor to clinical parts of regulatory dossiers and assists in the preparation of regulatory filings
- Maintains up to date knowledge of published literature in relevant therapeutic areas including the key development issues
- Establishes relationships with key external experts, consultants, opinion leaders and regulators
- Advanced degree desirable (MD/PhD/PharmD, or other), but candidacy may be supported by demonstrable significant hands-on experience in clinical research (5 to 10 years of clinical development including team leadership).
- Significant prior experience with drug or biologics development programs, preferably through all stages of development.