Planet Pharma is seeking a strong and skilled CMC project manager to drive process development and CMC activities to support early-stage clinical development programs.
The ideal candidate will identify, implement, and organize CMC activities and support Global Operations and R&D groups to successfully execute projects, support clinical operations, and lead planning activities.
Responsibilities:
* Partner with Global Operations team to manage CMC activities.
* Partner with R&D team to support current clinical trial execution efforts.
* Develop and maintain integrated project plans (dashboards and databases) to identify/communicate inter-dependencies as well as critical path activities across multiple programs.
* Work collaboratively with team leads to track milestones and coordination of program deliverables for successful management of projects.
* Partner with other Project Managers to implement best practices across teams e.g., planning, project risk management, team performance, timeline development.
* Track and monitor key milestones and decision points to drive delivery of project objectives.
* Identify and help manage risks, conflicts and barriers to project success.
* Effectively communicate with team members, senior leaders and key stakeholders on the status, objectives, risks, and mitigation plans associated with the various projects, as well as ensure teams are aware of current integrated program timelines.
* Facilitate project team meetings using meeting management best practices to drive cross-functional communication, timely and effective decision making, and successful execution of objectives.
* Directly manage projects with minimal supervision.
Qualifications:
* Bachelor’s degree in life science or health-related with proven experience working in the Biotech/Pharma and proven experience working in Project Management.
* PMP certification desired but not required.
Skills and Abilities:
* Prior experience in development of biologics is preferred and experience with Oncology/Hematologics experience is a plus.
* Broad knowledge of the clinical development and biopharmaceutical manufacturing process.
* Strong analytical, problem-solving, and critical thinking skills.
* Must be able to interact and communicate effectively at all levels of the organization.
* Must be competent in utilizing information technology systems and project management tools including systems (Microsoft Visio, Excel, PowerPoint and others).
* Excellent organizational and time management skills.
* The ability to independently lead several projects simultaneously, an adaptive working style and a creative and thoughtful approach to problem solving.
* Thrives in a fast-paced and evolving environment.