The successful candidate will be responsible for leading a multi-function team through the clinical development of a novel T-cell based vaccine. The Program Lead (PL) will, along with the Genocea leadership, establish the objectives for the clinical phase of the product development. The PL will work with other functions, including pharmaceutical sciences & 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.
Collaboratively develop clinical program objectives with Discipline Leaders 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 the product development budget, milestones and timelines for the execution of the Clinical Program. Communicate output to Executive Team
Works with Program Team members to harmonize the Clinical Program with the overall Product Development Plan
Works with Project Managers and Clinical Operations to assure effective conduct of clinical trials, on budget and on time,
Works with Pharmaceutical Sciences & Manufacturing and Research to assure effective technical development and manufacturing operations development to supply for clinical trials, on budget and on time
Give presentations and lead discussions of data at internal meetings including Program Team, Executive Review meetings. Also may present to external audiences including consultants, KOLs, investigators, and regulatory meetings as necessary
Establishes relationships with key external experts, consultants, opinion leaders and regulators
Experience in and strong understanding of clinical and CMC development of drug and/or biologic therapeutics, oncology preferred
Demonstrated ability to lead a multi-function team within a matrix environment toward successful completion of program objectives in an inclusive and collaborative fashion
Organizational and communication skills to effectively articulate objectives, progress, and risks to Executive and Program 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 and CMC product development, clinical trial design, and execution
Previous experience in drug development in one of the fields of vaccines, immunology, or oncology is a plus.
Advanced degree desirable (MD/PhD/PharmD, or other), but candidacy may be supported by demonstrable significant hands-on experience in program leadership roles (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.