At DICE Therapeutics, we design and develop innovative therapies in immunology for patients with debilitating disease. Seeking to create a future where convenient oral medicines with biologic-like efficacy are available to patients with serious medical conditions, we are developing oral alternatives to medicines currently limited to injectable forms.

In this role, the Director/Sr. Director, Biomarker/Translational Pharmacology will: collaborate closely with multidisciplinary R&D functional areas to lead all aspects of biomarker development/assessment activities including strategic planning for biomarker identification, design, implementation, and vendor management for biomarker assay method development, assay validation and proper biomarker quantifications during clinical trials; collaborate with research team to further elucidate the mechanism of action of the clinical drug candidates; support regulatory submissions during early and late development stages to advance candidates in clinical development pipelines towards the final approval. This position reports to Vice President Development Sciences and is based in South San Francisco with potential for flexible work arrangements.

Key Responsibilities:

• Establish robust biomarker strategies by identifying and developing proper pharmacodynamic or pharmacological biomarkers that enable demonstrating target engagement, mechanism of action, or pharmacological activities of the clinical or development drug candidates.
• Responsible for the implementation of the biomarker strategies into the relevant clinical studies.
• Lead and/or oversee selected vendors for the method development/method validation activities for different biomarker assays.
• Contribute to clinical study protocol development and study report generation by designing fit-for-purpose sample collection schedule for biomarker assessment and proposing thorough data analysis strategy.
• Serve as the subject matter expert on research and development project teams and contribute to development strategies and clinical or nonclinical study designs by recommending proper pharmacodynamic biomarker assessment strategy, rationale for exposure target identification via careful evaluation of exposure-biomarker response relationship when possible.
• Analyze, integrate, interpret, and summarize biomarker or exposure-response data from nonclinical or clinical studies, present and contextualize meaningful findings and recommendations to internal project teams and to senior leadership, clinical investigators, health authorities, or at external scientific conferences.
• Responsible for biomarker-specific sections in internal and external documents (including study protocols, regulatory, reports, lab manuals etc) and address inquiries from site staffs, vendors, or regulatory authorities.
• Develop and manage the budget for necessary clinical biomarker assessment, select and manage proper clinical assay vendors, manage the timelines of vendor deliverables and effectively prioritize tasks among different programs.
• Manage future hires for biomarker function, oversee employee performance/career development and timelines for deliverables when necessary.

Preferred Experience and Education:

• PhD, Pharm D or MD in a relevant scientific field, e.g. Immunology, pathology, pharmacology, molecular biology, or related scientific discipline with at least 12 years of relevant biotech/pharma drug development experience or translational research, with profound experience and exposure to discovery and development of biomarkers in immunology, either in a research or clinical setting; prior experience with targeted immunology therapeutics highly desirable.
• Demonstrated expertise in proper platform of assay development (e.g. Flow cytometry, mRNA assessment, CyToF assay, cell based assays, etc) evaluating pharmacological activities of development drug candidates, with a deep understanding of immunologic mechanisms underlying complex diseases.
• Experience in authoring pharmacology/MOA or PK/PD outcome sections in support of IND/NDA (or international equivalent) submissions using CTD format, and experience in interactions with different regulatory agencies.
• Have a thorough understanding of GxP regulations, familiarity with current clinical study related US and ex-US regulatory guidance documents and standards.
• Prior experience in working with and managing of CRO/vendors for analyzing clinical biomarker samples.
• Strong scientific background and scientific reasoning ability in proactive identification of potential issues, with excellent critical thinking and ability to draw conclusions and make appropriate decisions.
• Ability to work effectively and collaboratively on cross-functional project teams; demonstrated ability to multi-task, prioritize options, anticipate challenges, and execute on goals as a member of an interdisciplinary team is extremely important.
• Excellent verbal, presentation and written communication skills.
• Thrives in a collaborative team setting and is driven by a desire to be innovative in a high energy, small company environment

DISCLAIMER

The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.