Director, Clinical Pharmacology

Summary

Join Apogee Therapeutics as their Director, Clinical Pharmacology and contribute to the growth of their Clinical Development team. You will lead clinical pharmacology programs in immunology & inflammation, strategically planning drug development activities. This role involves collaborating with various departments, analyzing clinical PK/PD data, and authoring clinical study reports. You will also develop and implement quantitative approaches to drug development and lead the authoring of clinical pharmacology sections in regulatory documents. The position requires a PhD or PharmD with relevant experience and expertise in clinical pharmacology. Apogee offers a competitive compensation and benefits package.

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
• 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

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 Influences and strategically manages across clinical and business functions and understands the impact of business decisions and solutions
• 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 functional areas on outcomes and deliverables to meet conflicting demands (time, cost, quality/performance)
• Lead authoring clinical pharmacology sections of clinical and regulatory documents, including protocols investigator brochures, INDs, 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

Preferred Qualifications

• 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 highly preferred (eg 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)

Benefits

• A great culture, grounded in our C.O.R.E. values: C aring, O riginal, R esilient and Egoless
• Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly
• Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
• Flexible PTO
• Two, one-week company-wide shutdowns each year
• 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