Director, Clinical Pharmacology

Role Summary

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.

Key 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

Ideal Candidate / Qualifications

What We Offer

Equal Employment Opportunity : Apogee Therapeutics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.

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