This rapidly growing and highly successful nonprofit whose mission is to accelerate cures through stem cell research. We are seeking a Program Manager/Director to run cell therapy development programs from the research / preclinical phase through clinical development.
We are seeking a creative, highly motivated program manager/director. This person will have a strong scientific background in biopharmaceutical product development, project management and proven experience in preclinical through phase II clinical development programs. In this role, you will work with the team to develop the project plans, timelines and budget, lead the plan execution, handle interaction with key partners (e.g., regulatory, trial sites, clinicians, scientists), coordinate materials and operations for key meetings (e.g., FDA, Vendors, etc), and ensure appropriate and timely decision-making and progress. You will set the agenda and chair recurring project team meetings, and ensure effective cross-functional communications are achieved with all team members. You will also highlight risks, timeline delays and other issues to Senior Management.
Key Responsibilities include:
- Coordinates and handles the design and execution of cross-functional project plans for preclinical and early clinical development of cell therapies including CMC and clinical manufacturing, regulatory affairs, clinical development. Tracks progress against plans.
- Manages program team(s) and is responsible for working closely with program team members to handle the strategic and operational aspects of the program(s), including developing overall tactical implementation plans, fully integrated program timelines and budgets. Tracks and monitors key achievements and decision points to drive delivery of project objectives.
- Maintains frequent communication with the cross-functional project team members and key internal partners so that all parties are aware of current project status, issues, contingencies, and milestones.
- Prepares summary information on program progress, timeline updates and risk assessment for management presentations.
- Leads team meetings and ensures that clear actions and decisions are documented, communicated, enabling timeline achievement.
- Handle the preparation of the quality assurance documents to enable regulatory filings.
- Collaborate with various partners and consultants to ensure alignment around regulatory requirements and resulting operational design and regulatory submissions.
- 5-10 years of experience in the life sciences industry, with 3-5 years of shown project management experience handling cross-functional product development efforts.
- Excellent project management skills with an integrated view of business and scientific issues.
- Bachelors or Advanced degree in Biology, cell biology, or other related scientific area or MBA a plus.
- Experience in development of advanced therapy biologics/cell therapies, iPSC technology a plus.
- Project Management Professional (PMP) certification or equivalent training.
- Proficient in MS Office suite, including MS Project.
- Excellent verbal/written skills.
- Willing and able to learn new skills to meet changing needs of the organization.
- Ability to work in open collaborative environment and align objectives across multiple organizations.
- A real passion for building new, novel therapies for patients.
Please email CV to firstname.lastname@example.org