Gamida Cell is an advanced cell therapy company committed to finding cures for blood cancers and serious blood diseases. We harness our cell expansion platform to create therapies with the potential to redefine standards of care in areas of serious medical need. Gamida Cell is a publicly traded company (Nasdaq: GMDA).
Omidubicel, Gamida Cell’s lead investigational product candidate, is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with hematologic malignancies. Omidubicel is the first bone marrow transplant product to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration and has also received Orphan Drug Designation in the U.S. and EU. Omidubicel is currently being evaluated in an international, multi-center, randomized Phase 3 study in patients with high-risk blood cancers, and positive topline data from the study were reported in May 2020.
General Scope and Summary
This is an exciting opportunity to work in a multi-faceted program management role. The Program Manager will provide project management support to the cross-functional program teams to successfully support the progression of drug development projects in all phases. These responsibilities will include managing program plans, timelines, critical path activities and operations support at all levels to ensure seamless execution of the program. The Program Manager provides support and facilitates proactive planning, issues identification and risk mitigation discussions with the cross-functional program teams and Executive Leadership to ensure successful and timely execution of programs. The Program Manager will ensure that the program strategy is clearly integrated into the project budget and operational plans. Initially the key responsibilities will be for the omidubicel program and other earlier programs, as applicable.
Roles and Responsibilities
- Develop and maintain detailed project plans, monitors progress to timelines and budget, supports resource management, risk management and change management to deliver against agreed strategic objectives.
- Establish cross-functional team and coordinate meetings to support research, development, clinical, manufacturing, and regulatory activities, including setting agendas, capturing meeting minutes, documenting decisions and ensuring appropriate follow-up for action items.
- Ensure alignment within project teams, relevant communication with managers and leadership teams.
- Drive collaboration, cooperation and communication across cross-functional teams to achieve stated goals.
- Assist with execution of project plans within a team environment. Institute a development pathway with decision stage gates.
- Interface with Finance to coordinate and improve accuracy of budgeting, accounting and forecasting for program related activities. Ensure detail on investments to be made across the program and spend vs. forecast are aligned.
- Maintain close relationships with projects teams and departments to ensure that all critical parties are aware of project activity, issues and contingencies.
- Assist in facilitating information flow between team members; strive to identify and resolve issues arising on the project.
- Develop and implement communication tools that enhance information exchange and stimulate creative project interactions.
Experience, Education and Specialized Knowledge and Skills
- Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient.
- Key understanding of the drug development process and key functional responsibilities involved in the development of a drug candidate from IND enabling studies through to IND/CTA and BLA/NDA/MAA filings. Commercial launch experience a plus.
- Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations.
- Strong knowledge of project management software/tools including but not limited to the Microsoft suite of products, Gantt chart tools, other technical tools as applicable.
- Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.
- Strong ability to communicate in English, verbally and nonverbally.
- Bachelor’s degree in science, business or equivalent.
- 7+ years’ experience in scientific project leadership or program management in the biotechnology/pharmaceutical industry.
Travel: Regular travel between the Gamida Cell facilities in Jerusalem and Kiryat Gat. Minimal international travel required, once travel resumes
Reports to: Chief Medical officer
To apply: Send resume and cover letter to firstname.lastname@example.org.