Project Manager 2, Translational Sciences
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.
BioMarin’s Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases. Come join our team and make a meaningful impact on patients’ lives.
This individual project manages drug development programs for the Research and Early Development (RED) organization that range from late-stage research, IND-enabling, through post approval phases, for both nonclinical and clinical endeavors. This individual will partner with the drug program Early Development Team (EDT) Lead in driving the operational and strategic direction in order to meet the program’s corporate goals and objectives, within budget and on time, primarily concerning Research, Bioanalytical, Immunogenicity, Clinical Pharmacology and Toxicology. This individual will identify and manage project-related priorities; maintain and track high-quality integrated project plans and dashboards to enable accurate reporting and decision making; enable effective team meetings and high-performance teams; manage risk assessment/escalation; develop strategies for monitoring progress and for intervention/problem-solving in collaboration with stakeholders. The Project Manager interacts with individuals within RPT as well as across all departments ranging from Drug Discovery to Commercial to ensure corporate goals are met.
- Responsible for project managing 2-3 programs in Discovery/IND-enabling and/or clinical development phase for the RED organization
- Manages SharePoint Team Collaboration Sites and associated dashboards for the EDT alignment and communication
- Develops detailed project schedules that integrate key activities, timelines, and tracks the critical path for assigned projects
- Develops, independently and as part of a team, decision-making methodologies, tools and solutions for the EDT to identify complex issues with cross functional mid- to long-term project- and program-level impact
- Manages project risk assessment and reporting to applicable stakeholders
- Responsible for ensuring accurate budget information is detailed for each functional group within the EDT, and communicating change or out of scope requirements
- Partners with the EDT Lead to facilitate the Team meetings, including but not limited to, meeting organization, meeting summaries and follow up on cross-functional actionable items
- Utilizes strong influence management skills with the EDT functional leads to coordinate cross-functional efforts and meet overall team objectives. Functional leads include: Pharmacology and Toxicology, Immunogenicity Assessment, Clinical Pharmacology, Bioanalytical Sciences, Research and other ad-hoc members such as Clinicians, Nonclinical Study Management, Regulatory etc.
- May mentor and/or supervise junior staff
- Other duties as assigned
- 4-8 years of work experience in drug development (pharma/biotech or contract research organization), with a minimum of 3-5 years of direct project management experience in early and/or late stage clinical development
- Ability to drive, motivate and enable effective team meetings and high performing teams, while developing and maintaining professional interpersonal relationships with colleagues
- Strong understanding of GLP, GCP & GMPs
- Strong documentation, organization and time management skills in a fast-paced environment
- Experienced with Project Professional software
- Minimum: Bachelor’s (BS/BA) in Biological Sciences or closely related field
- Experience in the overall drug development process across various modalities including Gene Therapy, Biologics & Small Molecule
- 2-4 years of nonclinical project management experience for IND-enabling (2+ drug class types)
- Strong familiarity with Regulatory submission requirements (IND through BLA/NDA)
- Experience with nonclinical study management/monitoring
- Experience with Microsoft Excel, SharePoint, PowerBI (PBI) and Microsoft Teams
- PMP certification preferred (or equivalent)
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.