Associate Director/Director, External Collaborations-1

Responsibilities

• Drive Pharmacovigilance partnership strategy
• Define strategy for alliance partnerships as it relates to pharmacovigilance
• Perform Due Diligence assessment for operational aspects for pharmacovigilance
• Lead negotiations in alignment with strategies for acquisition, divestures, co-development/promotion, clinical collaboration, distribution and promotion, and other agreement types
• Transfer the agreed upon elements to operations team for inclusion in PVAA
• Author and review PVA and associated documents, as required
• Maintain up-to-date knowledge of GVP regulations and guidances, globally and processes within GPS
• Lead Implementation of Pharmacovigilance partnership strategy
• Lead implementation of partnership strategy with accountability for alliance performance measures
• Develop and lead areas for integration and transition through influence and effective project management
• Collaborate effectively externally and internally
• Review and advise on term sheet/contract development for business partnerships, in-licenses and divestitures.
• Develop and influence relationships with external parties, Lilly cross-functional teams, and EC team consistent with Team Lilly behaviors
• Serve as point of escalation and effectively communicate with alliance partners, key stakeholders, and Lilly cross-functional teams
• Train GPS representatives on due diligence themes
• Participate and support audits and inspections (internal, external party, or regulator audits and inspections)

Requirements

• Bachelor’s degree in business, healthcare, life sciences, and/or legal fields or equivalent experience is required.
• Experience in the Pharmaceutical industry, minimum 5 years’ experience in areas of Pharmacovigilance, Regulatory, Business Development and/or Clinical Development.
• Experience with contracts/agreements and negotiation with external parties
• Managing external relationships through effective alliance and vendor management and understand rules for maintaining confidentiality and materiality.
• Experience with cross-functional project management (scope, timeline delivery, risk management, prioritization, communication planning)