Director, Project Management - Operational Excellence

Company Overview
FibroGen, Inc. is a biopharmaceutical company committed to discovering, developing, and commercializing a pipeline of first-in-class therapeutics. Founded in 1993, and a public company since 2014, FibroGen is headquartered in San Francisco, with 325 employees in the US and 300 employees across 5 locations in China.
The Company applies its pioneering expertise in hypoxia-inducible factor (HIF) and connective tissue growth factor (CTGF) biology to advance innovative medicines for the treatment of unmet needs. The Company has commercialized one drug, Roxadustat, an oral small molecule inhibitor of HIF prolyl hydroxylase activity, for anemia associated with chronic kidney disease (CKD) in China, Europe and South America. Roxadustat is also in clinical development for anemia associated with myelodysplastic syndromes (MDS) and for chemotherapy-induced anemia (CIA).
The Company is also in Phase III clinical development with Pamrevlumab, an anti-CTGF human monoclonal antibody, for the treatment of idiopathic pulmonary fibrosis, locally advanced unresectable pancreatic cancer (LAPC), and Duchenne Muscular Dystrophy (DMD). Data read outs are expected this year (2023).
Furthermore, the Company’s R&D organization expects to submit to IND filings before the close of 2023.
Position Overview
This function serves as a leader for the OpEx PM to provide strategic and operational business excellence across all Drug Safety (DS) and Regulatory Affairs (GRA). This function oversees the achievement of the strategic goals and monitors and tracks all progress toward these strategic goals. In addition, this function monitors budgets, forecasting, and operating capital for DS &GRA.
The OpEx PM will provide hands-on project management, change management and continuous improvement leadership to support DS and GRA. Responsibilities of the role will focus on implementing improvements in alignment with the FG business operating model. This includes delivering strategic change projects and applying suitable methodologies and techniques to support both business functions to identify, prioritize, plan, and deliver sustainable solutions.
This role is responsible for working with FG VP, Global Head of Drug Safety and FG VP, Head of Global Regulatory Affairs along other key FG leaders to drive key projects (new and ongoing) to support FG’s evolution.
The OpEx PM is responsible for all elements of project management.The PM is responsible for creation and maintenance of project plans, status reporting, risk management, stakeholder management and proactive communications to key stakeholders (both within an external to FG). The scope includes supporting, prioritizing, and coordinating cross-functional projects, review and tracking of top deliverables.
Contribute to supporting high-performing, strategic, effective, and patient-focused organizations that effectively interface with other functions to cultivate a climate of operational excellence, team innovation, and continuous improvement as we continue growing into a global team.
Job Responsibilities:
Support Global Head of Drug Safety and Head of Global Regulatory Affairs on the following tasks:

• Develop agenda, facilitate discussion, and record minutes for selected meetings
• Track operating capital and forecasting, HC, and capacity planning.
• Work with the teams to design, develop and monitor progress against strategic goals and programs.
• Ensure that assigned initiatives are on track ( monitoring/reporting progress and follow-up on action items)
• Other duties as assigned
• Maintain high standards and levels of scientific and clinical knowledge in the assigned areas
• Ensure PV and RA have representation and a voice on key cross-functional initiatives. As appropriate, this role may support company-wide initiatives
• This role is both strategic and tactical, requiring an agile thinker with strong planning ability, interpersonal and communication skills, along with scientific and business acumen to work across DS and GRA to advance strategic planning and team communication platforms
• Participate as project manager for ongoing operational excellence and process enhancements, including updates to procedures and templates

Education & Experience

• Strong customer focus (e.g., regulatory, PV functions, clinical development)
• Ability to be flexible and quickly realign resources when necessary in order to meet critical project timelines.
• Working knowledge of US and other pharmacovigilance and global regulatory requirements. Demonstrated ability to take initiative for problem solving, handle multiple priorities, maintain confidentiality, and operate with poise and professionalism in a complex environment is required.
• Experience with budgets and budgeting
• Excellent verbal and written communication skills, with a ‘can-do’ team player mindset
• Minimum of a bachelor’s degree, science-based degree preferred and at least 5 years of project or program management experience required, preferred PMP or Six Sigma certification.
• Strong business knowledge of processes in Pharmacovigilance and Regulatory Affairs. Hands-on experience in PV, Regulatory, and/or R&D required.
• Tools: Proficiency in MS PowerPoint, MS Project, and advanced skill in software such as Visio, SmartSheet Expert knowledge in the practical aspects of PMO, techniques and tools.
• Advanced meeting facilitation skills to achieve consensus among diverse stakeholder groups.

SALARY RANGE
$224,000.00-$244,700.00
FibroGen is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender identity/expression, creed, national origin/ancestry, age, alienage or citizenship, status, age, sex, sexual orientation, marital or domestic/civil partnership status, disability, veteran status, genetic information, or any other basis protected by law.FibroGen will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the San Francisco Fair Chance Ordinance.
At FibroGen we continue to strive to build a diverse and equitable workplace; we share the typical minimum and maximum salary ranges on all job postings. For annual base pay, we typically set standard ranges for positions based on function and level benchmarks. Further, we establish fixed annual bonus targets, expressed at a % of annual base pay, based on level in the organization. Bonus awards are determined based on assessment of individual and corporate goal achievement. All compensation offers of employment are determined by multiple factors including a candidate’s relevant qualifications, work experience, skills, and other factors and may vary from the amounts listed above.
Notice to Recruiters and Search Firms
FibroGen does not accept unsolicited resumes or communications. Contact with a hiring manager or submission or presentation of candidates by recruiters or placement agencies without a current signed agreement with FibroGen will not constitute, in any form, a financial obligation or agreement for recruitment services or placement support or consulting fees.
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