Program Lead

Position Summary

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.

Primary Responsibilities

  • 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

Required Skills

  • 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.

Educational Requirements

  • 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.

Director, Discovery

Position Summary

Genocea Biosciences, Inc. is a fast paced, innovative cancer vaccine and cell therapy company based on a unique screening technology (ATLAS™) enabling the identification of novel T cell antigens in samples originating from individuals suffering from cancer or other diseases. To date, this screening technology has delivered a number of completely novel antigens for various intractable infectious diseases and has enabled the initiation of a Phase 1/2a clinical trial to develop a personalized vaccine for solid tumors. The successful candidate for this position will be expected to lead the Discovery team and help broaden the application of the ATLAS™ technology to diverse new therapeutic areas and other immunological functions. The candidate will demonstrate deep mastery and up-to-date knowledge of T cell and innate immune cell biology, as well a detailed understanding and fluency in state-of-the-art high throughput cell-based assays. Extensive automation experience is also required. The candidate should have significant experience managing teams of associate and senior scientists as well as a keen ability to crystalize, communicate and implement strategy at all levels of the company. The ideal candidate should have 10+ years of experience in the pharmaceutical and/or biotechnology industry along with outstanding scientific credentials in the form of an extensive and relevant peer-reviewed publication track record. The candidate will also be an outstanding communicator, both in scientific and project-related strategy.

Primary Responsibilities

  • Leads team responsible for identification of neoantigens for personalized vaccine and cell therapy development

  • Plans and directs scientific projects aimed at miniaturizing and automating the high throughput identification of T cell antigens and T cell receptors. Identifies and manages necessary resources for achievement of goals.

  • Ensures that documentation of experimental data meets standards suitable to support publication, FDA submission and patent filing

  • Assists in the coordination and execution of research collaborations

  • Hires, manages, trains and mentors technical team consisting of junior and senior scientists. Establishes expectations, defines roles, supports career development and manages performance

  • Creates vision, delineates, communicates and implements technology development strategy for the entire company

  • Communicates with Executive team and peers to ensure that technological innovations are fully integrated in the organization

Competencies

  • Prior experience (5-10 years) working successfully in a management role. Demonstrated success in managing staff performance.  Ability to motivate staff to work effectively and hold staff accountable to individual and departmental goals

  • Documented topic-specific scientific expertise (peer-reviewed publications, invited speaking engagements)

Required Skills

  • Extensive experience in high-throughput cell-based assays, T cell biology, molecular biology, and automation. Knowledge of cell imaging and TCR sequencing preferred

  • Demonstrated skills in data analysis of complex multidimensional datasets, including laboratory and IT automation technologies

  • Excellent critical thinking, time management and organizational skills.

  • Excellent written and verbal communication skills, with the ability to present at the highest level.

  • Ability to engage, sustain and influence effective relationships at the management level.

Education Requirements

  • PhD in immunology, cell biology or related field

  • 10+ years relevant industrial experience

  • Background in immuno-oncology