BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.
We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
PRODUCT DEVELOPMENT GLOBAL PROJECT MANAGEMENT
Global Project Management (GPM) is responsible for providing best-in-class project management practices to optimize Core Teams, Clinical Development Teams, Study Execution Teams and other partner-teams in the execution of planning, teamwork, decision-making and communication. GPM is committed to ensuring the timely delivery of high quality data and results and achievement of corporate goals.
The Project Manager 1 role is a critical transitional role from coordination and support focused responsibilities to overall project management responsibility.
An individual in this role must not only demonstrate strong foundational core competencies, such as communication, teamwork and problem solving, but also foundational technical competence for project management and drug development and study design.
The PM 1 will apply these competencies to more complex operational execution responsibilities in a cross functional study and project team environment.
- May collaborate with Team Leaders to enable team development and follow-through of the Clinical Development Plan (e.g., partnering with, and gaining cross-functional alignment on, CDP deliverables) and/or Protocol execution plans
- Facilitate team development and management of Risk Mitigation Plan for the Clinical Development Team (CDT) and Study Execution Team (SET) and ensuring execution of the risk mitigations; ensures alignment between the SET and CDT risk mitigation plans
- Build, maintain and control the cross functional timeline for the execution of Clinical Development Plan and/or protocol execution - highlight dependencies, milestones, deliverables, and critical path; create timeline scenarios as needed and facilitate cross-functional reviews
- Help to identify and leverage interdependencies in short-, mid-, and long-term project and study plans
- Ensure functions are tracking to key deliverable and milestone timelines.
- Advocate and drive for overall project execution quality – Propose, facilitate and implement plans to resolve issues and execute corrective actions
- Facilitate team meetings in collaboration with the Clinical Development Team Leader (CDTL) and/or Study Execution Team Leader (SETL) - develop meeting agendas, issue meeting minutes, and track action items to completion with cross-functional leads
- Collaborate with the CDTL and/or SETL to ensure all team members read, understand and execute their roles according to the team Charters
- In collaboration with team leads, identify, communicate and escalate Study Team interdependencies, issues, perspectives and key decisions as appropriate
- Communicate objectives, plans and timelines to the CDT and SET
- Contribute to and facilitate the development of appropriate metrics for the SET
- Support ad-hocworking groups that result from CDT and SET needs
- Support the execution of steering committee meetings or clinical advisory boards in collaboration with Clinical Science
- Work with Team Leaders to coordinate cross-functional activities from data generation through clinical study report development in collaboration with BioMetrics, Clinical Medical Writing and other functions
- Working with Project Management Lead provide support other teams as appropriate
- Coordinate conducting Lessons Learned initiatives for the CDT, SET and / or other cross-functional teams as appropriate
- In addition to the above the successful candidatewill be expected to provide:
- System administration support for the timeline management system
- Manage permissions in the records management system
No people management responsibilities.
- Minimum of 4-8years total relevant experience (including industry, project management, or academia), with at least 2-4 years in a project management role. CAPM or comparable certification a plus.
- BA/BS in a scientific or technical field. Experience in lieu of education accepted.
WORK ENVIRONMENT / PHYSICAL DEMANDS / TRAVEL
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts; fumes or airborne particles; toxic or caustic chemicals; risk of electrical shock and vibration. The noise level in the work environment is usually moderate.
The employee may frequently be required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and taste or smell. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities by this job include close vision, depth perception and ability to adjust focus.
Some travel may be required.