The Project Manager will be responsible for ensuring the scope and direction of programs through all stages of the candidate development process, including Phase 1-3 clinical development studies. This position will be able to develop and manage detailed project plans, drive the matrix project teams to achievement of key milestones, and facilitate communication throughout all levels of the organization. In addition, the Project Manager may play a leadership role in the future development of new programs such as investigator-sponsored trials (IST), compassionate use and named patient protocols.
Duties and Responsibilities Include But Are Not Limited To:
Applies Project Management best practices in the development, initiation, planning, execution, control and closing of projects
Develops detailed project plans and timelines and tracking of key deliverables and milestones for preclinical and clinical programs
Manages day to day project activities for the Program Teams
Responsibility for project performance, risk management, and issue resolution at the project team operations level
Represents, in partnership with the Program Lead, the teams and programs at Sr. Management meetings and participating in and/or leading project reviews
Facilitates communication and has demonstrated ability to share complex information with diverse audiences across all levels within the organization
Provides support for new pipeline assets transitioning from research to the clinic
Performs other duties as required
A strong track record of leading teams to evaluate new therapies in the pharmaceutical industry (oncology or gene therapy experience preferred).
Technical experience in a discipline associated with drug development is required
Knowledge of issues that drive early and late stage development projects and proven ability to develop and manage complex project plans, timelines and critical path tasks is required
Excellent written and verbal communication as well as interpersonal, negotiation and conflict resolution skills are essential
Strong organizational, analytical, and time management skills with demonstrated ability to effectively multitask and advance various projects simultaneously
Ability to hold oneself and others accountable for commitments in a productive and assertive manner
Ability to drive consensus and decision making
Innovative and collaborative spirit
Must be able to prioritize and work effectively in a constantly changing environment.
General understanding of the FDA, EMA, ICH and other guidelines relevant to the pharmaceutical industry
Previous experience with preparation of a NDA/BLA is desirable
Education and Experience:
An Advanced Degree (PhD, MS) or equivalent experience in a relevant scientific and/or Project Management discipline is required; PMP certification is highly desirable.
Five to 7 years in biotech/pharma industry along with relevant project management experience managing drug development programs
Experience with biological products or cancer immunotherapeutics is desirable, but not required
Proficiency in Microsoft Office suite applications and high-level of proficiency in Microsoft Project