Senior Director, Quantitative Pharmacology and Pharmacometrics

Job Description This role provides strategic leadership and scientific oversight to part of the cardiometabolic (CMD) therapeutic area (TA) portfolio in the department of Quantitative Pharmacology and Pharmacometrics (QP2). The Senior Director is responsible for application of cutting-edge quantitative pharmacology and pharmacometrics strategies to propel the internal portfolio forward leveraging the full strength of the QP2 department. Reporting directly to the QP2 CMD Head and serving as their delegate when needed, the individual will collaborate closely with the QP2 CMD leadership team and broader organization to ensure consistent, high-value quantitative pharmacology contributions throughout the CMD portfolio from discovery through life cycle management. Senior Directors are recognized as scientific thought leaders that develop and implement translational PK/PD strategies, characterize clinical pharmacokinetics and pharmacodynamics, and shape regulatory strategy, dose selection and go/no-go decisions.

Responsibilities

Provide scientific and operational oversight for projects, under the direction of the Executive Director of QP2- CMD Leveraging end-to-end drug discovery/development and disease area expertise to independently provide day-to-day scientific oversight to individual contributors Serving as an expert representative for QP2 on discovery and drug development teams and engaging in cross-functional and governance discussions, including business development and licensing evaluations Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics, contributing to cross-functional regulatory strategy, authoring regulatory documents (INDs, CSRs, CTDs) Developing and applying mechanistic, disease progression and comparator modeling platforms to help drive portfolio decisions In partnership with Executive Director of CMD, identify resource needs and contributes to resource allocation internally. Serve as QP2 lead on assigned projects.

Required

Ph.D./PharmD or equivalent degree with significant years of experience where "experience" means having a record of increasing responsibility and independence in a similar role in pharmaceutical drug development or regulatory. Educational background in biopharmaceutics, pharmaceutical sciences, pharmacometrics, chemical/biomedical engineering, mathematics, statistics/biostatistics, computational biology/chemistry, or a related field Extensive experience in developing quantitative strategies for impacting pipeline decisions, and drug development expertise Demonstrated ability to lead an interdisciplinary team or taskforce, and/or to oversee the work of others Record of ability to operate in an inclusive and high-performance work environment applying enterprise ways of working principles including fostering collaboration and driving results, while managing ambiguity Relevant regulatory and quantitative pharmacology experience Proficiency in written and verbal communication, interdisciplinary collaboration, and problem scoping and planning.

Preferred

CMD Therapeutic area or disease knowledge Expert skills in performing population PK/PKPD analyses using standard pharmacometrics software (e.g. NONMEM, R, Monolix, Phoenix, etc.) Scientific understanding of biopharmaceutical and ADME properties across modalities Record of applying models to inform decisions Ability to influence regulatory strategies including prior experience independently authoring and defending regulatory filings for marketing authorization (NDA/MAA) Recognized leader in the field of quantitative pharmacology with a track record of sustained external visibility through publications, presentations and/or involvement in professional organizations.

Required Skills

• Biopharmaceuticals
• Biopharmaceutics
• Business Intelligence (BI)
• Computational Biology
• Database Design
• Data Engineering
• Data Modeling
• Data Science
• Data Visualization
• Drug Development
• Drug Discovery Process
• Machine Learning (ML)
• Pharmaceutical Biology
• Pharmaceutical Sciences
• Pharmacodynamics
• Pharmacokinetics
• Pharmacotherapeutics
• Product Approvals
• Software Development
• Stakeholder Relationship Management
• Strategic Leadership
• Waterfall Model

Preferred Skills

• Biopharmaceuticals
• Biopharmaceutics
• Business Intelligence (BI)
• Computational Biology
• Database Design
• Data Engineering
• Data Modeling
• Data Science
• Data Visualization
• Drug Development
• Drug Discovery Process
• Machine Learning (ML)
• Pharmaceutical Biology
• Pharmaceutical Sciences
• Pharmacodynamics
• Pharmacokinetics
• Pharmacotherapeutics
• Product Approvals
• Software Development
• Stakeholder Relationship Management
• Strategic Leadership
• Waterfall Model

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.