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    Senior Director, Clinical Pharmacology - San Francisco, CA, United States - FibroGen, Inc.

    FibroGen, Inc.
    FibroGen, Inc. San Francisco, CA, United States

    1 week ago

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    Description
    APPROVED FOR REMOTE WORK Company Overview FibroGen, Inc. is a biopharmaceutical company focused on accelerating the development of novel therapies at the frontiers of cancer biology. Pamrevlumab, an anti-CTGF fully human monoclonal antibody, is in clinical development for the treatment of metastatic pancreatic cancer and locally advanced unresectable pancreatic cancer (LAPC). Roxadustat (???, EVRENZO) is currently approved in China, Europe, Japan, and numerous other countries for the treatment of anemia in chronic kidney disease (CKD) patients on dialysis and not on dialysis. Roxadustat is in clinical development for chemotherapy-induced anemia (CIA) and a Supplemental New Drug Application (sNDA) has been accepted for review by the China Health Authority. FibroGen recently expanded its research and development portfolio to include antibody-drug conjugate (ADC) and immuno-oncology product candidates for the treatment of solid tumors. For more information, please visit Position Summary Senior Director Clinical Pharmacology will provide leadership and implementation of the clinical pharmacology and pharmacokinetics strategies and initiatives across our early and late-stage clinical programs. The successful candidate is highly motivated with deep knowledge in clinical pharmacology and quantitative sciences applied to large and small molecules. The candidate will represent the function on program and strategy teams and work closely with scientists and other development functions to implement stage-appropriate development plans that will lead to clinical programs and protocols acceptable to global regulatory authorities. The candidate will be responsible for recruiting and managing top clinical pharmacology talent. Our experienced group emphasizes a collegial, collaborative, innovative, and fun environment.


    In this role you will:

    • Develop strategies in clinical pharmacology and quantitative sciences to meet regulatory requirements
    • Drive execution of clinical pharmacology and quantitative sciences vision through execution, interpretation, and presentation of results to project teams, executive review and decision-making bodies
    • Proactively and decisively represent and be an effective spokesperson for key principles on cross-functional project teams
    • Develop and implement new clinical pharmacology tools and technologies to drive efficient drug development
    • Identify, develop, and manage collaborative relationships with vendors to apply state-of-the art population PK, PK/PD, PBPK, and QSP modeling concepts
    • Author/review/approve clinical protocols, analysis plans, study reports, and regulatory submissions
    • Provide clinical pharmacology expertise and oversight during clinical study execution
    • Organize and interpret data, and present analyses to key internal (development teams, senior management) and external stakeholders (advisory boards, scientific meeting abstracts, posters, and manuscripts)
    • Recruit, supervise, develop, and mentor junior level scientists
    • Develop and maintain collaborative working relationships with colleagues within and outside the department
    • Maintain scientific awareness regarding advances in indications of interest, regulatory awareness regarding new guidance and rules, and industry awareness regarding trends and competition through literature, conferences and stakeholder interactions Requirements:
    • Ph.
    D., Pharm.
    D., M.D. or equivalent advanced degree in related discipline


    • Minimum of 10 years of industry experience with both small and large molecules, as well as knowledge of human immune system for development of immuno-oncology drugs
    • Must have a demonstrated ability to critically analyze problems and provide innovative solutions along with strong leadership skills
    • Demonstrated expertise managing/developing staff and building infrastructure with department processes, systems and Standard Operating Procedures (SOPs).
    • Thorough knowledge of current and emerging scientific standards and regulatory requirements for global territories
    • Proven track record of extensive experience in the design, coordination and implementation of clinical studies
    • In depth knowledge contemporary PK, population PK, QSP modeling concepts, data analysis, and interpretation; demonstrated record in applying these concepts to support clinical development programs; desire and curiosity to acquire scientific knowledge for portfolio projects
    • Flexible, results oriented and demonstrated ability to work in a fast-paced, timeline-driven environment
    • Excellent written and verbal communication skills and ability to convey complex technical information clearly
    • Previous experience in biologics and small molecules, as well as knowledge of human immune system for development of immuno-oncology drugs
    • Must have strong computer skills with a proficiency in Microsoft Project, Word, Excel, PowerPoint SALARY RANGE
    $283,100.00-$347,800.00 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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