Associate Director, Pharmaceutical Development (EDG-2026008)

Role Summary

The Associate Director, Pharmaceutical Development will lead end-to-end development of small molecule drug products across preclinical, clinical, and commercial stages. This role involves strategic planning, technical leadership, and cross-functional collaboration to ensure robust, scalable, and regulatory-compliant drug product development. In collaboration with and through active management CDMOs, ensure that drug product supplies are available in a timely manner at various stages of clinical development and commercialization.

Responsibilities

• Lead formulation strategy, prototype selection, and process development for small molecule drug products (focus on OSDs; include enabling formulations if needed—amorphous solid dispersions, lipid-based systems, salts/co-crystals).
• Manage drug product CDMOs and collaborate with internal stakeholders in the development of small molecule drug products, including technical, logistical and project management aspects to ensure program timelines are met.
• Develop and implement comprehensive strategies for process development including solid form characterization, evaluation of multiple formulation options, process design and optimization, scale-up, and manufacturing of drug product (DP) under both non-GMP and cGMP to enable pre-clinical and clinical studies, respectively.
• Provide in-depth technical expertise in support of CMC regulatory submissions, due diligence, and other appropriate regulations and guidelines, and active participation in establishment and justification of specifications.
• Contribute to company strategy by formulating appropriate CMC objectives and priorities in collaboration with the team and drive these objectives and goals through a superior level of scientific knowledge and innovative technical skills.
• Research and identify new opportunities outside of assigned work that augment the company’s mission, vision, values, and goals
• Communicate professional insight and company’s position on CMC issues to internal stakeholders and external partners
• Influence collaborators and consultants by demonstrating a deep understanding of all aspects of the company’s projects, data, results, and objectives
• Provide critical evaluation of CMC team deliverables, constructively challenging assumptions and offering well-reasoned insights and practical solutions
• Drive implementation of new technologies and approaches in formulation and process development.
• Work across internal departments to maintain credibility, trust, and support of employees and other stakeholders
• Demonstrate leadership and professionalism to build external relationships crucial to the success of the organization
• Maintain scientific records in clear required form
• Update job knowledge by participating in educational opportunities; reading professional publications; maintaining professional networks; and participating in professional organizations
• Read, understand, and comply with all workplace health and safety policies; safe work practices; and company policies and procedures
• Perform other duties as assigned by supervisor

Qualifications

• 10+ years of related small molecule drug product development and manufacturing experience in CMC/cGMP environment
• 3+ years of management and oversight of CDMOs for non-GMP and cGMP activities from preclinical through Phase 3
• Ability to navigate and craft global regulatory CMC documents
• Subject matter expert with exceptional command of scientific literature in the field and related disciplines
• Familiarity with QbD principles and risk-based development approaches
• Ability to work in a fast-paced, matrixed environment
• General and scientific computer and software application proficiency

Education

• Ph.D. in Pharmaceutics or scientifically related field or M.S. with additional professional experience

Additional Requirements

• Travel: Travel up to 15% (domestic and international)