Job Description
Who We Are For more than two decades, going our own way has led to countless breakthroughs, bettering the lives of those suffering from rare genetic disease. In 1997 we were founded to make a big difference in small patient populations. Now we seek to make an even greater impact by applying the same science-driven, patient-forward approach that propelled our last 25 years of drug development to larger genetic disorders, as well as genetic subsets of more common conditions. Through our unparalleled expertise in genetics and molecular biology, we will continue to develop targeted therapies that address the root cause of the conditions we seek to treat. Applying our knowledge to make a transformative impact is not just a calling, but an obligation to those who will benefit most. The end goal has always been better lives and now we can reach more. And the more people we reach, the more our impact can grow. We transform lives through genetic discovery. Our Culture Our desire to make a positive impact on our patients extends to our employees and BioMarin is committed to fostering an inclusive environment where every person feels seen, valued, and heard \u2013 so employees can thrive in all areas of their lives, in and outside of work. We seek to provide an open, flexible, and friendly work environment to empower people and to provide them with the ability to develop their long-term careers. Ultimately, we want to be an organization where people enjoy coming to work and take pride in our efforts to help patients. SummaryAt BioMarin, the Late-Stage Clinical Development (LCD) organization is responsible for overseeing clinical programs across various phases, from proof-of concept to Phase 3 and BLA/NDA/MAA filing. The LCD organization provides leadership for clinical strategy and oversight to ensure excellence in clinical trial conduct, data analysis and interpretation, publication preparation, and safety monitoring.\u00A0BioMarin 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 aims to improve life and health outcomes for people with rare diseases by advocating the use of innovative BioMarin therapeutics, advancing the standard of care and providing personalized support and services globally.\u00A0 \u00A0As part of the LCD organization, the Patient Centered Outcomes Science (PCOS) team is responsible for leading and ensuring successful development and execution of patient centered outcomes and endpoint strategy in early and late-stage clinical trials and observational studies to support the product lifecycle. \u00A0Key Responsibilities:Strategy & Planning Oversee the development and maintenance of the PCOS workstream timelines supporting the overall clinical program strategy (highlighting interdependencies, milestones, deliverables, and critical path). Collaborate with PCOS leads, Global Project Management, and Regulatory Project Management to: Lead annual program and budget planning in\u00A0support of corporate objectives \u00A0 Link PCOS project and clinical program schedules to monitor and report on progress against PCOS milestones, deliverables, and outcomes at each stage of a program Develop PCOS risk mitigation plans (i.e., identifying, analyzing, prioritizing, and managing project risks) for all programs Support scenario planning, facilitating cross-functional input to enable decision-making Facilitate PCOS-specific communication across cross-functional teams Collaborate with PCOS leadership on: Strategic policy development and execution Defining company-wide PCO workstream roles and responsibilities and establishing cross-functional ways of working\u00A0Operational Execution\u00A0 Manage integration of PCOS workstreams into the clinical development plan (CDP) Support scenario planning and ensure effective communication with other program teams, project managers, and functional area leadership. Ensure cross-functional teams and project managers are tracking key PCOS deliverable and milestone timelines Prepare reports/dashboards to facilitate communication Advocate for overall project execution quality \u2013 propose, facilitate and implement plans with PCOS leads to resolve issues and execute corrective actions Organize and facilitate PCOS internal team and cross-functional team meetings (i.e., issuing meeting agendas and minutes, monitoring action items to completion, and communicating/escalating issues and decisions cross-functionally)\u00A0Cross-Functional Influence\u00A0 Liaise across cross-functional teams and sub-teams to ensure consistent communication and alignment Communicate PCOS information and activities to stakeholders outside of Clinical Science (including external stakeholders) Partner with various stakeholders to transition products from development to marketed stage Within cross-functional teams, foster a culture that promotes respect, teamwork, collaboration, openness, and appreciation\u00A0Education & Experience BA/BS in a scientific or technical field. MA desirable. 6 years total relevant experience (including industry, project management, or academia) with Master\u2019s degree; 8 years with Bachelor\u2019s degree Project and/or Program Management in a Biotech or Pharmaceutical Company experience preferred PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19. 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.
