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.
We seek an exceptional Principal/Senior Scientist of Clinical Pharmacology to join our clinical pharmacology team.
The Senior Scientist in Clinical Pharmacology is responsible for designing, implementing, and interpreting clinical pharmacology studies to support the development and regulatory approval of new drugs or therapies. This role involves conducting complex research, analyzing data, and providing critical insights into the pharmacokinetics, pharmacodynamics, and safety profiles of investigational compounds. This position reports to senior director of clinical pharmacology, and is based in South San Francisco, with potential for flexible work arrangements.
- Study Design: Develop and lead the design of clinical pharmacology studies, including bioavailability, bioequivalence, pharmacokinetic, and pharmacodynamic studies. Ensure that study designs meet regulatory requirements and scientific objectives.
- Collaborate with cross-functional teams to provide clinical pharmacological expertise in the planning and execution of clinical trials. Assist in the development of clinical trial protocols and study documents.
- 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.
- Data Analysis: Analyze data from clinical pharmacology studies, interpreting results to guide decision-making regarding drug development, dosing strategies, and safety profiles.
- Manage and establish necessary modeling and simulation tools internally or via external pharmacometric resourcing, provide support to meet all modeling and simulation needs.
- Regulatory Compliance: Ensure that all clinical pharmacology activities adhere to regulatory guidelines and standards, including those set by the FDA, EMA, and other relevant agencies.
- Publication and Communication: Prepare and contribute to scientific publications, regulatory submissions, and internal and external presentations related to clinical pharmacology findings.
- Collaboration: Collaborate with other departments, including preclinical research, clinical development, and regulatory affairs, to ensure alignment on development strategies.
- Participate in 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 5-10 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 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.
- Thrives in a collaborative team setting and is driven by a desire to be innovative in a high energy, small company environment.
Preferred Additional Skills:
- Thorough scientific record keeping
- Strong organizational and time-management skills
- Excellent written and oral communication skills
- Team player; comfortable and effective in a collaborative research environment
Sr. Scientist 180,000 – 199,000
Principal Scientist – 199,000 – 265,000
The pay range for this position that we reasonably expect to pay. Individual compensation is based on various factors including, experience, education, skillset, and geographic location. This range is for the Bay Area, California location and may be adjusted to the labor market in other geographic areas.
The above information in 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.