Director, Clinical Pharmacology

Role Summary

Director, Clinical Pharmacology role leading clinical pharmacology programs in immunology and inflammation, providing strategic planning for drug development activities and influencing key clinical pharmacology strategies across the development spectrum from first-in-human through approval. Develop and implement quantitative approaches to drug development and collaborate with cross-functional teams and external partners. Strong communication to present Clinical Pharmacology information to teams, senior leaders, regulatory agencies, and external partners.

Responsibilities

• 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

Qualifications

• 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 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

Skills

• Model-informed drug development and PK/PD modeling
• Clinical pharmacology study design and execution
• Regulatory writing and interactions
• Cross-functional collaboration and leadership
• External CRO management
• Proficiency with PK/PD software (e.g., Phoenix WinNonlin, Prism, NONMEM, R, MATLAB)

Education

• PhD or PharmD required