About The Position

The purpose of the Associate Director/Director, External Collaborations is to lead pharmacovigilance (PV) strategy with alliance partnerships for Global Patient Safety (GPS). As a member of corporate due diligence or integration teams, this role evaluates business deals for safety operational risks and planning for PV system integration of acquisitions/divestitures.

Requirements

  • Bachelor’s degree in business, healthcare, life sciences, and/or legal fields or equivalent experience is required.
  • 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)

Nice To Haves

  • Highly effective communication, inclusive of active listening both written and verbal.
  • Ability to influence without direct authority over others
  • 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.

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 PVA
  • 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)

Benefits

  • company bonus (depending, in part, on company and individual performance)
  • company-sponsored 401(k)
  • pension
  • vacation benefits
  • medical benefits
  • dental benefits
  • vision benefits
  • prescription drug benefits
  • flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
  • life insurance
  • death benefits
  • certain time off and leave of absence benefits
  • well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
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