Clinical Pharmacologist - Apogee Therapeutics

We are seeking a Clinical Pharmacologist to join the Clinical Development team. In this newly created role you will provide clinical pharmacology expertise to a multidisciplinary team. This individual will be the primary clinical pharmacology lead for programs entering clinical development. This position will work in close collaboration with different functions, including preclinical toxicology, preclinical pharmacokinetics, translational medicine, clinical, operations, and regulatory affairs.

Key Responsibilities

• Provide Clinical Pharmacology expertise to inform strategy for Apogee’s development compounds using traditional and model informed drug development approaches
• Represent CP on project teams to provide strategic and scientific expertise
• 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
• Oversee PK/PD modeling to support dosing strategies for clinical programs
• Author clinical pharmacology sections of clinical and regulatory documents, including protocols investigator brochures, and INDs
• 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

• 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 the immunology and inflammation (I&I) space a plus
• Fluency in model-informed drug development, with hands-on modeling and simulation experience preferred
• 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 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
• Ability and willingness to travel up to 15-20% to company All Hands meetings and development team meetings

The anticipated salary range for candidates for this role will be $190,000 - $200,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.