Our Associates have worked with a large number of global leaders in Pharmaceuticals, Biotechnology, and Medical Devices. We have conducted a variety of strategic engagements throughout the product lifecycle — supporting work from concept development through market expansion. Our team has experience in Research & Development, Program & Project Management, Operations, Quality Assurance, Sales and Marketing, Human Resources, and Logistics within these industries.
Developed a Work-Measurement Course for a Leading Pharmaceutical Company
Brian developed a course for and trained-the-trainers within the client’s Human Resources group. The course was designed to provide instruction in using point factors to evaluate work complexity and design appropriate career paths and compensation strategy.
Integration Support for a Joint Venture Between Two Global Pharmaceutical Companies
A joint venture of two leading Pharmaceutical companies was looking for external support to establish the new organization. Brian led one of the workstreams that was focused on developing a new joint culture, identification and development of high-performers, development of new career path model, recruitment support, and reward and recognition. Over a five month period, the project implemented a number of quick-wins and formed a number of specialized teams to manage the change process over a longer term, including processes for sustaining change after the conclusion of the project.
Development of a Performance Management System for a Global Pharmaceutical Company’s Global R&D Organization
When a new Global Head of R&D came on board, he was not confident in the organization’s ability to effectively evaluate individual and group performance. Brian led a project team that designed a Scorecard and dashboards for the global R&D organization, worked with representatives from each function to identify and establish performance metrics, and developed a process for setting, updating, and evaluating performance against these metrics. He developed and presented training materials during the rollout to the different sites.
Conducted a Management Audit of Manufacturing Staff for a Global Pharmaceutical Company
In response to an FDA consent decree, the client was required to conduct an audit of their management across three of their manufacturing sites. Brian assisted in this audit at two of the sites: interviewing managerial staff, reviewing SOPs and processes, reviewing staff qualifications, and evaluating the training processes. As a result of the review, the audit team documented their findings and prepared as recommended remediation plan for the client. The remediation plan was used in the client’s response to the decree and was implemented.
Assisted with the Restructure of a Global Pharmaceutical Company’s Procurement Organization
The client undertook a program to reform their Procurement group. The overall project included an evaluation of all existing processes, structural design, and staffing. Brian worked with the Procurement leadership to assist with the organizational design and the transition to the new model.
Project Manage a Supplemental New Product Application (sNDA) for a Biopharmaceutical Company
The client was conducting an sNDA to gain additional indications on an existing product. Brian was asked to project manage the sNDA assembly and submission, coordinating the activities of different functions and external vendors (medical writers, clinical data submission, analytics). The sNDA was successfully submitted on time and budget.
Assisted with the Optimization of a Global Pharmaceutical Company’s Product Launch Processes
Brian worked with the client’s Business Process Excellence group in a project to document and optimize the processes for global product launches. The engagement included a series of cross-function workshops documenting the existing processes and responsibility of a variety of development teams, understanding redundancies and gaps, and building streamlined processes. The project resulted in improved standardization and transparency across the development pipeline.
Development of a Performance Management System for a Global Pharmaceutical Company’s Medical Science Liaison (MSL) Teams
A leading Pharmaceutical company sought assistance in evaluating and motivating high-performance in their MSL teams, considered to be a difficult function in which to develop performance metrics. Brian developed a Scorecard for the client and worked with the MSL team and Medical Affairs group to identify measures of performance, appropriate ways to quantify performance, and tie these to a reward system that would motivate the MSLs to exhibit the desired behaviors. The Scorecards and performance management system were rolled out across the US organization.
Organizational Design Support for a Leading Global Pharmaceutical Company’s Medical Science Liaison (MSL) Teams
As the result of some internal staffing changes, new senior leadership was emplaced at the head of the client’s MSL teams. In an unusual design, there was a joint leadership model in place — two executives, jointly leading the team, with no clear division of authority. Brian worked with the client to clarify roles, working with the two leads to organize the structure of their department, divide their areas of responsibility, and mange the change through their reorganization. Over the course of a year, we developed the organization into groups of MSLs specialized by Therapeutic Area and organized by geographic area. Leaders were assigned for each team and we established the processes for coordination of objectives across the group.
Designed the Program Management Office for a Global Medical Device Company
The client requested an assessment of their Project and Resource Management Capability. Brian conducted the assessment and recommended the development of a dedicated Program Management Office. He led the design of the organizational structure, the development of the positions comprising it, definition of the operating processes for the group, and how it interacts with other functions. The organization is now in place and running all new product development projects.
Designed a Project-Based Performance Management System for a Global Medical Device Company
The client did not have any method in place for incorporating performance feedback from cross-functional project teams into end-of-year evaluations. Brian assisted by creating Scorecards for project team members and designed a process for integrating the Scorecards into the client’s existing performance management system. He worked with representatives from the different client functions and in different geographies to identify appropriate metrics and build them into a metrics library. He advised the client on different reward strategies that can be used to motivate behavioral change. This has resulted in a new focus on development projects as the organizational priority and grants additional authority to Project Leaders.
Alignment and Redesign of the New Product Development Process for a Global Medical Device Company
The client was experiencing great variability in development timelines and extensive rework with some of their projects. After conducting an assessment, we recognized that there were a number of contributing problems: cross-functional activities were being led by engineers with an R&D functional bias, there were no standard project plans that would be used across projects, and there were different documents giving often contradictory guidance on what should have been standard processes. Brian led a team to develop a master project plan template that could serve as a standard base for future projects. This was derived from a review of existing documentation, workshops and interviews with different functional experts who have done the work, and input from functional leads. The resulting project plan eliminated many redundancies and provided a more disciplined approach to product development. As a next step, the team worked with each function separately to further develop their functional-specific project plans that would support the master plans.
Select Project and Resource Management Software
Brian assisted the Project Management Office of Surgical Device manufacturer to develop technical and user requirements for an enterprise Portfolio, Project, and Resource Management software package. Developed user requirements, compared leading software solutions, and conducted group decision workshops. Developed an implementation plan for the rollout.
Developed a Strategic Governance Model
Brian helped develop the strategic governance model that supports lifecycle management for a Surgical Device manufacturer. Developed communications and decision-making processes and tools for Invention (early R&D engineering and user requirements), Commercialization (project management, clinical studies, and regulatory), and Expansion (market analysis and sales/marketing activities) activities.
Capability Assessment / Select Project and Resource Management Software
Conducted a corporate-wide user requirements collection for a Portfolio, Project, and Resource Management enterprise system for a Medical Device company. Conducted PPRM process and capability assessment of several divisions’ project management offices. Developed a master user requirements document and recommendation for internal decision.
End-to-End Process Optimization
Brian assisted a client to develop a Stage Gate model and process redesign for End-to-End Innovation (from idea generation, through product development, to commercial launch) for a division of one of the world’s leading Pharmaceutical companies. Included mapping and refinement of processes across all functions, led workshops in Latin America, Europe, China, Asia-Pacific, and the Middle East, and the supporting tools. Supported the global implementation, including change management, project management support, training, and refinement of processes.
Develop a Marketing Competency Model
Brian led the development of a Competency Model for the Marketing function of a pharmaceutical company and worked with the organizational leadership to redesign their organizational structure and redefine the new positions.
Standardized Clinical Development Processes
Developed standardized and optimized global (US, Europe, Australia) processes for the Clinical Development department of a leading pharmaceutical company, following a series of mergers and acquisitions.
Developed a Repairs and Maintenance Strategy
Brian project managed a cross-functional client team (for a leading Pharmaceutical company) to develop an R&D Asset Management (inventory and repairs/maintenance) strategy. Included developing a strategy for repairing and maintaining all of the laboratory instrumentation, selection of a multi-vendor partner, and implementation across R&D sites.