Biopharmaceutical Project Manager
Hiring Company: Targazyme, Inc.
Location: Carlsbad, CA
Description: Biopharmaceutical Project Manager
Our firm, Targazyme, Inc. (formerly America Stem Cell, Inc.), is a clinical-stage start-up biopharmaceutical company developing enzyme platform technologies/products to improve efficacy outcomes for cell therapy and cancer. The corporate office is located in Carlsbad, CA. Targazyme, Inc. is entrepreneurial and fast-moving in nature and desires additional team members with similar qualities. Join the Team that has the ability to transform the field with this best-in-class, game changing technology!
The incoming Project Manager will report to the Chief Operations Officer and will be responsible for the coordination of all pre-clinical activity, working closely with Targazyme’s CRO. He or she will work closely with the development team, in house or outsourced, ensuring effective pre-clinical and clinical trial execution and regulatory submission.
The Project Manager’s responsibilities will include (but not be limited to):
- Leading and coordinating all domestic pre-clinical activity, working closely with CROs
- Interacting with the Targazyme Management Team as needed to effectively execute test processes
- Ensuring key resources are in place, accountabilities clear and timelines met to ensure proper study completion
- Being responsible for troubleshooting issues and delivering solutions
- Creating and managing consolidated timeline, integrated work plan
- Ensuring effective reporting and analytics to support the decision making process
- Aligning program-related activities owned by the business, such as change management, training, business process design, within program plan
- Surfacing issues that may impact intended outcomes, benefits, budget, scope, time
- Effectively managing changes to project/program scope with appropriate governance
- Ensuring that appropriate objectives are met and that Company resources are effectively deployed to meet strategic product development plans
- Liaising with multiple contractors and internal stakeholders, including manufacturing operations, CROs and business development
- Supporting the development of company and product positioning for investors, analysts, partners, and clinicians
Desired Skills and Experience
BS Degree in related field. The Project Manager will have 6+ years of experience in a pharmaceutical or biopharmaceutical company, shepherding the clinical development of drug candidates through clinical trials. The candidate should have experience in working with clinicians, CROs and other team members. Additionally, the Project Manager should have significant experience in supervision of projects and time-lines. The Project Manager must also have a good working knowledge of the drug development process, FDA requirements and good clinical practices.
The Project Manager will be a determined professional with strong interpersonal skills, and able to achieve results. Must be hands-on and detail-oriented, while still being able to see the big picture. He or she will be motivated by the opportunity to be part of a team, efficiently conducting clinical trials that meet regulatory and commercial requirements. A self-motivated, entrepreneurial, approachable, articulate team player, the Project Manager, will have the highest level of integrity and core value system that are consistent with the organization as a whole.
Commensurate upon experience. Pre-IPO company, cash component plus equity position.