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 (Sr.) Director of Clinical Pharmacology & Pharmacometrics will:
collaborate closely with multidisciplinary R&D functional areas to lead all aspects of clinical pharmacology and Pharmacometric activities including strategic planning of clinical pharmacology plans, design, execution, management and interpretation of clinical and clinical pharmacology studies, and support all necessary 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:

• Design and develop clinical pharmacology plan and overall strategies of characterizing PK/PD profiles of clinical drug candidates, ensures all critical clinical pharmacology assessments being assessed in alignment with FDA and international regulatory expectations.
• Lead the design, planning, execution, and interpretation of Clinical Pharmacology studies and dose regimen design/selection for early and late stage clinical studies. Contribute to study protocol development and study report generation.
• Develop and manage the budget for clinical pharmacology / pharmacometrics function, manage and develop the clinical pharmacology/pharmacometric team [including hiring new members, working with consultant(s) or vendors] and effectively prioritize tasks among different programs.
• Serve as the subject matter expert on research and development project teams and contribute to development strategies and clinical development plan by recommending proper PK/PD assessment strategy, rationale for proper dose and regimen selection, and providing modeling and simulation support.
• Represent clinical pharmacology in regulatory interactions, including preparing briefing packages, filing documents (e.g. IND, CTA, PIP, NDA), addressing inquiries from and participating in meetings with regulatory authorities.
• Analyze, interpret, and summarize PK/PD and exposure-response data from clinical studies, or review PK/PD data analysis outcomes from the vendors, and present and contextualize meaningful findings and recommendations to internal project teams and senior management.
• Manage and establish necessary modeling and simulation tools internally or via external pharmacometric resourcing, provide support to meet all modeling and simulation needs.
• Participate in and/or lead forums and process improvement/system initiatives critical to quality processes and works collaboratively with quality group to develop proper SOPs.

Preferred Experience and Education:

• PhD or PharmD in Pharmaceutics, pharmacology, Biology, or related scientific discipline with 10-15 years of relevant biotech/pharma drug development experience in a team-facing role; experience in popPK and other M&S approaches is desirable.
• Demonstrated expertise in clinical pharmacology study design (e.g. DDI, Organ impairment, TQT, BE/rBA study, and special population) evaluating small molecule drug candidates, prior experience with targeted immunology therapeutics highly desirable.
• Has a thorough understanding of GxP regulations, familiarity with current clinical pharmacology related US and ex-US regulatory guidance documents and standards.
• Experience in authoring pharmacology/dosing rational sections supporting IND/NDA (or international equivalent) submissions using CTD format, and experience in interactions with different regulatory agencies.
• Experience in working with and managing of pharmacometrics or Clin Pharm study vendors
• 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.
• Experience in managerial and/or leadership roles.
• Thrives in a collaborative team setting and is driven by a desire to be innovative in a high energy, small company environment.

Title will be commensurate with experience

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.