Senior Engineering Manager, LLM Platform
Snowflake
Director, Clinical Pharmacology
Apogee Therapeutics
full-time
Posted on:
Origin: • 🇺🇸 United States
Visit company websiteSalary
💰 $230,000 - $260,000 per year
Job Level
Lead
About the role
- Independently lead Clinical Pharmacology/PK/PD activities and provide scientific and strategic expertise to program teams, regulatory, and senior leaders to guide critical decisions and inform development plans
- Support pediatric development, including protocol development and dose selection.
- Develop and oversee implementation of clinical pharmacology studies from protocol development to final study reporting, in collaboration with cross-functional study team members, including Clinical Operations, Biometrics and Regulatory Affairs, as well as CRO partners
- Lead the analysis, interpretation, and reporting of clinical PK/PD data, author clinical study reports
- Develop and execute and/or oversee PK/PD modeling strategies to describe the relationship between drug exposure and response to support dose selection and overall development for clinical programs
- Provide clinical pharmacology timelines to program teams and negotiate with other functions on outcomes and deliverables to meet conflicting demands (time, cost, quality/performance)
- Lead authoring of clinical pharmacology sections of clinical and regulatory documents, including protocols investigator brochures, INDs, BLAs, and responses to regulatory agency comments
- Maintain a current understanding of PK and PD literature and methodology, as well as the scientific literature related to the emerging Apogee pipeline
Requirements
- PhD or PharmD with relevant expertise in clinical pharmacology or pharmaceutical science is required
- 5+ years of direct industry experience in conducting clinical stage drug development
- Experienced in developing clinical pharmacology plans and authoring relevant sections of clinical and regulatory documents
- Knowledge and experience in the application of current practices in the areas of clinical pharmacology, pharmacokinetic and pharmacodynamic principles, drug metabolism, bioanalysis, biopharmaceutics
- Experience in biologic drug development preferred, and/or immunology and inflammation (I&I) a plus
- Experience with late-stage development (Phase 2/3) preferred
- Fluency in model-informed drug development, with hands-on modeling and simulation experience highly preferred (e.g. NONMEM, R, Phoenix NLME, MATLAB, etc.)
- Experience working with external CROs
- Proficient in using common PK/PD modeling software (such as Phoenix WinNonlin, Prism, and other similar tools)
- Ability to work proactively and effectively, with exceptional creative problem-solving skills and self-motivation
- Ability to work in cross-functional teams within a highly dynamic environment
- Strong project management skills with a high sense of urgency, ability to collaborate and influence effectively cross-functionally
- Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
- Up to 15-20% travel is required to company All Hands meetings and development team meetings
