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We are seeking a motivated Director, Clinical Pharmacology, to join our growing Clinical Development team. In this role, you will lead clinical pharmacology programs in immunology & inflammation, providing strategic planning for drug development activities in line with departmental strategies, goals, and objectives. You will have a seat at the table to influence, decide, and recommend key clinical pharmacology strategies across the drug development spectrum, ranging from first-in-human through approval. You will develop and help implement quantitative approaches to drug development programs. You will work in close collaboration with different functions, including preclinical toxicology, preclinical pharmacokinetics, translational medicine, clinical development, clinical operations, and regulatory affairs. The position requires strong communication skills to lead and present key Clinical Pharmacology information to teams, senior leaders, regulatory agencies, and external partners.
Job Responsibility:
Lead clinical pharmacology programs in immunology & inflammation, providing strategic planning for drug development activities
Influence, decide, and recommend key clinical pharmacology strategies across the drug development spectrum
Develop and help implement quantitative approaches to drug development programs
Work in close collaboration with different functions
Lead and present key Clinical Pharmacology information to teams, senior leaders, regulatory agencies, and external partners
Independently lead Clinical Pharmacology/PK/PD activities and provide scientific and strategic expertise
Support pediatric development, including protocol development and dose selection
Develop and oversee implementation of clinical pharmacology studies from protocol development to final study reporting
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
Provide clinical pharmacology timelines to program teams and negotiate with other functions
Lead authoring of clinical pharmacology sections of clinical and regulatory documents
Maintain a current understanding of PK and PD literature and methodology
Requirements:
PhD or PharmD with relevant expertise in clinical pharmacology or pharmaceutical science
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
Fluency in model-informed drug development
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
Nice to have:
Experience in biologic drug development
Experience in immunology and inflammation (I&I)
Experience with late-stage development (Phase 2/3)
Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
Three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
Commitment to growing you professionally and providing access to resources to further your development
Apogee offers regular all team, in-person meetings to build relationships and problem solve
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