Director, Translational Medicine

The Associate Director/Director of Translational Medicine will be responsible for developing and executing Translational Medicine studies to support Fibrogen's oncology, immunology, and fibrotic disease area therapeutic pipeline molecules from first-in-human to late-stage trials. The successful candidate will have hands-on experience in design, execution, and analysis of biomarker strategy and data for pharmacodynamic response, proof-of-mechanism, and patient stratification/selection. Our group emphasizes a collegial, collaborative, innovative, and fun environment.
In this role, you will:

• Develop and implement comprehensive biomarker plans to support assets in the company's pipeline.
• Develop fit-for-purpose biomarker assays based on scientific questions and clinical requirements.
• Oversee and coordinate the transfer of assays, methodologies, and scientific protocols with external analytical laboratories while ensuring data accuracy, reliability, and adherence to quality standards.
• Manage relationships with external partners to troubleshoot issues and optimize protocols for robust and timely delivery of biomarker data.
• Work closely with R&D cross-functional teams to design biomarker discovery studies, including genomics, proteomics, metabolomics, or imaging-based approaches, to identify and validate novel biomarkers associated with disease progression, treatment response, or patient selection.
• Collaborate with Clinical Development and Clinical Operations to ensure biomarker sample collections, analyses, data transfers, and reporting are performed in accordance with study protocols and in compliance with regulatory requirements.
• Actively participate and contribute to cross-functional Translational Medicine and targeted biomarker sub-teams to achieve project team goals and enable decision-making at key R&D milestones.
• Support drafting of biomarker-related sections in clinical study-related and regulatory documents (such as clinical protocols, ICFs, INDs, IBs, clinical study reports, etc.).
• Maintain scientific awareness regarding advances in indications of interest, regulatory guidance, and the competitive landscape through literature, conferences, and stakeholder interactions.

Requirements:

• Ph.D., Pharm.D., M.D., or equivalent advanced degree in biomedical sciences.
• Minimum of 10 years of experience, including industry experience, in immuno-oncology with significant hands-on experience in Translational Medicine and biomarker strategy.
• Proven track record with hands-on technical expertise to identify/implement cutting-edge methodologies.
• Experience in designing and executing biomarker validation studies, including assay development and analytical performance evaluation.
• Good understanding of clinical trial biosample logistics and analytical and clinical validation of biomarker assays.
• Demonstrated ability to successfully influence, negotiate, and lead in a highly matrixed environment and with colleagues from diverse personal and professional backgrounds.
• Excellent interpersonal and communication skills, including a sophisticated ability to write and present biomarker plans and results in a clear and concise manner.
• Up-to-date knowledge of regulatory guidance, considerations, and expectations for biomarkers.
• Experience in managing vendors, ensuring deliverables on time and with high quality.
• Independently motivated, detail-oriented, and good problem-solving ability.
• Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities.
• Proven ability to thrive in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient.
• Must have the ability to think strategically and communicate clearly to set and guide the Translational Medicine strategy.

SALARY RANGE
$222,400.00-$290,300.00
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.
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