Associate Director, External Collaborations

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
**Organization Overview**:
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
Associate Director/Director, External Collaborations will lead alliance partner relationships for Global Patient Safety (GPS) and Global Regulatory Affairs (GRA) operations and lead vendor management for GPS function. This role supports the management of safety information and regulatory strategy for Lilly marketed products and compounds in development.
**Responsibilities**:
Drive Pharmacovigilance/Regulatory partnership strategy
- Define strategy for business partnerships as it relates to pharmacovigilance and regulatory affairs
- Perform Due Diligence assessment for operational aspects for pharmacovigilance and regulatory affairs
- Lead negotiations in alignment with strategies for acquisition, divestures, co-development/promotion, clinical collaboration, and distribution and promotion, and other agreement types
- Transfer the agreed upon elements to coordinator for inclusion in PVA
- Review Pharmacovigilance Agreement and associated documents, as required
- Maintain up-to-date knowledge of regulations and processes within GPS and GRA
Lead Implementation of Pharmacovigilance/Regulatory 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
- Define and execute data migration in collaboration with cross-functional teams and IDS
Vendor Management across GPS
- Establish framework for effective vendor management in defining good oversight and measures for monitoring to ensure compliance.
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 business partners, key stakeholders, and Lilly cross-functional teams
- Guide affiliate PV teams regarding local partnership agreements
- Train GPS and GRA representatives on due diligence themes
- Participate and support audits and inspections (internal, external party, or regulator audits and inspections)
**Basic Requirements**:
- Bachelor’s degree in business, healthcare, life sciences, and/or legal fields or demonstrated equivalent experience is required.
- Proven expertise in the Pharmaceutical industry, minimum 5 years’ experience in one of the following areas; Pharmacovigilance, Regulatory, Business Development or Clinical Development.
**Additional Preferences**:
- 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.
- Highly effective communication, inclusive of active listening both written and verbal.
- Ability to influence without direct authority over others
- Demonstrated success in team-based, cross-functional project management (scope, timeline delivery, risk management, prioritization, communication planning)
- High degree of learning agility and flexibility in a dynamic environment
- Ability to make risk-based decisions in timely manner
- Attention to detail and problem-solving skills.
- Proficient computer skills (Microsoft Suite of Apps, Word, Excel, PowerPoint, Project, Visio)
- Fluency in English - written and verbal
Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
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