Dir/Sr. Director, Development Process Optimization
Summary & Scope of Position:
The Director of Development Process Optimization will lead teams to identify gaps, address and implement new processes and improvements within the clinical development functions. These functions include, but are not limited to, Clinical Operations, Safety, Biometrics, Regulatory, and Project Management. This role will consider ways to gain efficiencies in our development processes, determine how to best scale-up and structure our development processes, and define and implement the tools we need to align, energize and arm product development teams to plan, execute and communicate more effectively. This person must be interested in working in a fast-paced, team-oriented environment and be adaptable to rapidly changing priorities.
- Support the development leadership team to identify, prioritize and fill gaps related to later stage development activities.
- Apply project management methodologies and drug development expertise to support the definition, prioritization, and implementation of development processes, procedures and tools, including but not limited to:
- Provide training to our product teams on how to put an integrated project plan in place for a new or existing project.
- Establish a Change Control process to review and provide final approval for ongoing study timeline and budget changes.
- Optimize the Stage Gate Review process by defining minimum criteria and requirements for each phase of development to help establish transparency and set clear expectations for Go/No Go decisions at each gate.
- Conduct an internal SOP gap analysis to ensure that SOPs are in place for all critical processes and activities.
- Develop a new product development roadmap that includes major milestones and deliverables required at each phase of development.
- Develop a RACI chart for each major deliverable identified in the new product development roadmap.
- The ideal candidate will have 10+ years of biopharma cross-functional team experience and at least 4 years’ leading cross-functional teams in a PM role with demonstrated ability to achieve business results.
- Proven ability to implement new development processes, change management, strong negotiation skills and ability to work effectively with multi-functional teams at all levels of the organization.
- Experience working with consultants to help implement new processes; previous experience managing direct reports.
- Ability to think strategically and tactically and communicate ideas effectively.
- Expertise with MS Project, PowerPoint, Excel, Word, SharePoint
- Familiarity with drug development processes, GCP, cGMP guidelines and FDA guidelines required.
- PMP certification a plus
- Travel up to 10%, may include international travel, including time at the Oss, Netherlands campus.