Associate Vice President - Drug Product Development

Overview

The AVP is responsible for providing technical leadership to multidisciplinary teams, scientists and engineers involved in the development and commercialization of biopharmaceutical processes and products. In alignment with Lilly’s priorities, the AVP provides technical oversight and/or leads organization initiatives, evaluates and implements new capabilities/technologies and provides strategic technical direction through broad influence both 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.

• Owes 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

• 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, will consider skills commensurate with a PhD scientist in addition to 15 to 20 years of parenteral process and drug product development experience relating to biotechnology, biopharmaceuticals).

• Experience with both early and late- phase clinical programs.

• Preparation of control strategies and regulatory submissions supporting clinical development.