Associate Vice President - Drug Product Development

Role Summary

The Associate Vice President, Drug Product Development, provides technical leadership to multidisciplinary teams involved in the development and commercialization of biopharmaceutical processes and products. In alignment with Lilly’s priorities, the AVP provides technical oversight and leads organizational initiatives, evaluates and implements new capabilities and technologies, and provides strategic technical direction to influence decisions internally and externally.

Responsibilities

• Leads by example by providing technical leadership for specific development projects, collaborations, and component initiatives.
• Maintains intimate knowledge of scientific and operational issues of specific projects, collaborations, and initiatives to support pipeline progression and resolve problems across functions.
• Guides platform development associated with the clinical development and commercialization of bioproduct molecules for new Lilly products.
• Owns the strategic technical agenda. Provides scientific leadership for setting the strategic direction in terms of science / technology / business and ensures implementation to support the pipeline and meet the organizational objectives.
• Serves as scientific advisor, monitors project progress, ensures scientific rigor, and serves as a technical resource when issues arise.
• Collaborates with technical leaders in other divisions to ensure alignment of scientific promotion expectations, objectives and work processes.
• Communicates the technical successes and failures to scientific staff to influence a culture of continuous learning and improvement.
• Advocates creation of strategic partnerships.
• Holds leadership positions on steering teams or provides strategic oversight for partnerships and/or alliances.
• Represents CM&C in due diligence assessments of in-license, out-license opportunities.
• Writes and/or reviews technical documents (internal reports, external disclosures, regulatory documents).
• Fosters and maintains expectations for compliance with quality, safety, confidentiality and corporate integrity standards/policies.
• Provides technical consultations to Discovery, Regulatory, Quality, Medical, PK/PD, Toxicology, ADME, Clinical Pharmacology, and Manufacturing.
• Provides career development coaching, feedback and assessment to scientists within BR&D and other organizations.
• Maintains awareness of regulatory requirements and ensures development strategies will meet those expectations.
• Engages with the external scientific community and stays current with relevant literature.
• Holds positions on external scientific advisory boards, expert committees or panels.
• Shares and applies key learning with the broader organization and external scientific community.

Qualifications

• Required: Ph.D. in chemistry, chemical engineering, analytical, biochemistry, biology, or pharmaceutical sciences and a minimum of 10 years of parenteral process and drug product development experience (alternatively, 15–20 years of parenteral process and drug product development experience relating to biotechnology/biopharmaceuticals).
• Required: Experience with both early- and late-phase clinical programs.
• Required: Preparation of control strategies and regulatory submissions supporting clinical development.
• Preferred: Comprehensive knowledge and understanding of traditional and new modalities of parenteral drug product development; parenteral manufacturing and aseptic technologies; and drug product process development.
• Preferred: Background encompasses both innovation and technical development of oligos, protein, peptide, and gene therapies.
• Preferred: Technical leadership in the areas of formulation and drug delivery.
• Preferred: Extensive experience collaborating with key partner functions, including discovery, and drug product delivery and device to develop innovative solutions with a patient focus in an integrated fashion.
• Preferred: Excellent communication, interpersonal, and leadership skills; thorough understanding of the development process, manufacturing needs and regulatory requirements to ensure the efficient progression of projects through the development continuum to successful product registration and launch.