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General Description:

The Associate Director, Clinical Pharmacology & Pharmacometrics will be responsible for developing and executing clinical pharmacology and modeling & simulation strategies for small molecules and biologics assets in the company portfolio. She/He will provide clinical pharmacology & pharmacometric expertise in characterizing the pharmacokinetics profiles; dose selection justification; characterizing QT prolongation potential etc. This will be accomplished by working in close partnership with internal Clinical Pharmacology and Pharmacometrics members as well as cross-functional teams such as Clinical Development, Biometrics, Biomarkers, Regulatory, CMC etc. Responsibilities will include planning and reviewing study designs & analysis plans; analysis & interpretation of pharmacokinetic and pharmacodynamic data; as well as authoring and defending the Clinical Pharmacology sections of regulatory filings.

As we are a growing team, we are flexible on role leveling. As such, candidates presenting skills at more senior or junior levels will be considered as well.

Essential Functions of the job** **:

+ Lead clinical pharmacology or pharmacometric activities on project teams

+ Develop and execute clinical pharmacology and pharmacometrics strategies to mitigate risks and support development of small molecule and/or biologics drug candidates from pre-IND and first-in- human testing through all phases of clinical development.

+ Develop clinical pharmacology study designs and collaborate with CROs and Clinical Operations to write study protocols, amendments, and reports, ensuring that designs and documents meet global regulatory and compliance requirements and project timelines.

+ Contribute to the design and analysis of PK data from patient clinical studies.

+ Conduct hands-on clinical PK, population PK and exposure-response data analysis.

+ Analyze, interpret, summarize, and present data to internal project teams, senior management, and to global health authorities.

+ Discuss clinical pharmacology & pharmacometric plans to support development and filings with health authorities.

+ Author, review, and finalize relevant sections of IND/CTA filings as well as NDA/MAA/BLA submissions and respond to health authority questions related to these submissions.

+ Provide clinical pharmacology & pharmacometrics reviews on business diligence activities.

Supervisory Responsi** **bi** **lities:

+ Mentoring junior members of the group as needed

+ Manage clinical pharmacology vendors, consultants for specific project needs

**Computer** **Skills** : Proficiency with NONMEM/Monolix and R/S-Plus preferred.

**Other** **Qualifications** : A Ph.D. or equivalent in Pharmacokinetics, Pharmaceutical Sciences, Biomedical Engineering or related discipline with at least four years of industry and/or related post- doctoral experience is preferred. Demonstrable scientific, clinical development and regulatory experience based on prior experience with NDA/BLA/MAA filings, hands-on modeling & simulation experience and/or publications are essential. Prior experience in oncology drug development is preferred.

**Travel** : Ability to travel to manage clinical pharmacology collaborations and to health authority interactions within and outside the US

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.