Group Leader - Senior Director, Quantitative Pharmacology and Pharmacometrics - Cardiometabolic

Responsibilities

• Leading a team of up to 4 QP2 scientists including people management, scientific and operational oversight, 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

Requirements

• Ph.D./PharmD or equivalent degree with at least 10 years of experience in pharmaceutical drug development or regulatory
• 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 Skills

• Cardiometabolic 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

Skills

• Clinical Development
• Clinical Pharmacology
• Data Modeling
• Data Science
• Data Visualization
• Dose Response Analysis
• Drug Development
• Pharmaceutical Sciences
• Pharmacometrics
• Product Approvals
• Regulatory Strategies
• Stakeholder Relationship Management
• Strategic Leadership
• Team Management