Executive Director, Small Molecule Analytical Research & Development

Job Description

The Executive Director of Small Molecule Analytical Research & Development (AR&D) works cross functionally with partners in Process Research & Development and Pharmaceutical Sciences to provide strategic and technical leadership for both drug substance and product development for the small molecule pipeline. The Executive director has primary responsibilities for the development, validation, implementation, and technology transfer of analytical test methods to support advancement of the pre-clinical and clinical development pipeline of new small molecule products.

The Executive Director reports directly to the Associate Vice President, Small Molecule Analytical Research & Development (AR&D) and will be directly responsible for a multidisciplinary team of people managers and scientists, approximately 50-75 people. The team works closely with leaders and scientists within Discovery, Pre-clinical Development, Manufacturing, Quality Assurance and Regulatory groups and provides technical insights and support for our portfolio of projects from candidate nomination to marketing authorization.

The Executive Director manages the work within their group to ensure that the goals of the project teams are met in a timely, cost-sensitive, phase-appropriate and compliant manner. They would be accountable for the growth/career development and performance of the Small Molecule Analytical Research & Development teams with a demonstrated ability to collaborate, build high-performing teams, develop diverse talent and set and achieve a strategic direction for the team.

Responsibilities include, but are not limited to, the following:

Scientific Excellence & Innovation: Responsible for leading the overall scientific, technical and operational efforts of a department within Small Molecule Analytical Research & Development with delivery of analytical characterization data, methods, and process knowledge in a timely manner needed to meet project milestones and associated regulatory requirements. This includes development of novel tools and processes to position Small Molecule Analytical Research & Development to deliver against future pipeline needs.

Quality and Regulatory Standards: Develops and implements quality standards and specifications for drug substance and drug product. Ensures the delivery of high-quality CMC sections for IND/CTA/NDA filings. Addresses quality-related inquiries from regulatory agencies to support clinical trial and commercial marketing applications.

Compliance Systems: Sets a high compliance standard and ensures that systems and resources are in place to conduct the activities of the laboratories in compliance with cGMP/GLPs (as needed), SOPs, good documentation practices, and OSHA safety standards and in accordance with corporate requirements. Partners to ensure overall laboratory readiness for regulatory inspections and internal audits.

Project Management and Teamwork: Responsible for quality, quantity and timelines for …