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Senior Efficacy Lead

Senior Efficacy Lead

Published: 13 June 2016

Main Purpose of Position

The incumbent will participate as a member of a multidisciplinary team focused on characterizing and developing innovative compounds/products for a variety of veterinary applications. The incumbent will design and implement strategies involving the efficacy technical program as well as coordinate and oversee activities performed by Third Parties. The individual will also ensure efficacy studies and programs are conducted in a timely manner, within budget and in compliance with applicable regulatory requirements.

The individual in this role is also expected to perform key leadership responsibilities which provide innovative solutions, a positive and motivating work environment, ultimately delivering the Elanco pipeline.

Key Leadership Responsibilities

  • Proactively search for solutions. Make complex technical decisions within guidelines of resource availability and limited data

  • Recognized as a corporate expert in key areas of expertise including examples of being sought out cross-functionally or across organizational boundaries

  • Work effectively and flexibly within and across all Elanco R&D teams and external collaborators to achieve overall Elanco R&D deliverables

  • Create a positive work environment that is aligned with company objectives and values

  • Provide and accept challenge to deliver innovative technical solutions and create an innovative culture

  • Create an engaging culture with a “Play to Win” mentality

  • Identify and utilize methods to deliver individual objectives in a high quality, timely, cost-effective manner

  • Provide information to facilitate accurate and timely project and budget forecasts

  • Manage project timeline and budget deliverables to facilitate delivery of the Elanco pipeline

Key Technical Responsibilities

  • Design efficacy programs within a Companion Animal product development team and assume overall responsibility and accountability for these programs

  • Develop integrated strategies for assessing the efficacy of innovative compounds/products; define and facilitate achievement of critical project milestones; ensure critical issues are correctly and timely resolved; proactively identify project

  • Coordinate and lead a multi-disciplinary effectiveness team and manage and direct operational aspects of in vivo effectiveness programs including laboratory studies and clinical field trials

  • Develop, in collaboration with other internal/external partners, study protocols and/or study designs and oversee study execution and compliance with protocols and applicable regulatory requirements

  • Ensure efficient and open communication with other team members, functions, and CROs; facilitate conflict resolution when needed

  • Coordinate statistical analyses with statisticians and prepare or review final study reports and other documents required for submission to regulatory authorities

  • Prepare regulatory effectiveness technical sections in partnership with Elanco Regulatory Affairs team and assist with regulatory submissions and responses

  • Contribute to financial tracking and forecasting of project spending and ensure invoices are submitted in a timely manner

  • Liaise with Elanco personnel e.g. new product planning and marketing teams, procurement, legal, QA. Liaise externally with key opinion leaders, clinical experts and other contacts

  • Provide technical support and/or consultancy for other teams as a Subject Matter Expert in efficacy

  • Prepare manuscripts, as required, to support projects

Educational Requirements

Doctor of Veterinary Medicine (DVM) or PhD degree in a related biological field.
8+  years of industry experience with at least 5 in clinical development, with documentation of and conducting R&D activities in a regulated environment related to effectiveness of animal health therapeutics and/or parasiticides.

Additional Skills / Preferences

  • Experience in companion animal therapeutics drug development

  • Excellent knowledge of GCPs, GLPs, VICH and other relevant Guidelines

  • Previous experience working with external contract research organizations

  • Demonstrated capability to take personal risk to provide appropriate technical influence to tough decisions

  • Experience with U.S. submissions and interactions with CVM

Language Requirements

Proficiency in oral and written English

Personal Considerations

Domestic and international travel required (~10%)

If you are interested in this role please apply directly through Lilly/Elanco Careers (job ID: 27268BR).

All our open positions are published on www.elanco.com.

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