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Clinical Leader – Pet Health Clinical Development, Dermatology and Therapeutics jobs in United States
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Elanco · 16 hours ago

Clinical Leader – Pet Health Clinical Development, Dermatology and Therapeutics

Elanco is a global leader in animal health dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. As a Clinical Leader, you will conduct and coordinate the development of global Pet Health clinical development programs, planning and executing studies in compliance with regulatory standards.
ManufacturingPetSupply Chain Management
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H1B Sponsor Likelynote

Responsibilities

Formulate comprehensive clinical development plans for each new product. Build effective relationships within and outside Research and Development (Portfolio and Project Leadership, Regulatory Affairs and Pharmacovigilance, Clinical Development Sciences (CDS), R&D Quality Assurance, Marketing, Manufacturing and Quality) during development of products and life cycle management to assure that all parties involved meet critical deadlines and deliver work with appropriate quality attributes (GCP, GLP)
Specific duties include executing individual clinical programs. In cooperation with other teams (i.e. CDS, Biostatistics, Regulatory Affairs), design and write protocols for laboratory and field efficacy studies and TAS to generate information that will lead to regulatory approval of products. Work cooperatively with CDS to select suitable research facilities and qualified researchers to execute protocols. Coordinate with other teams to ensure study monitoring according to current applicable regulations, company policies, and management expectations. With support from other teams (i.e. Data Management, Medical Writing, Biostatistics, and internal / external SME reviewers), analyze and interpret results and author study reports. Work collaboratively with Regulatory Affairs to prepare reports and data for submission to regulatory agencies and present data to regulatory authorities and/or scientific meetings
Ensure quality assurance/regulatory compliance and participate and/or lead administrative and procedural activities such as development of new processes and / or functional procedures
Attend scientific meetings, continuing education courses and keep abreast of scientific advances and new developments in the animal health industry and veterinary profession

Qualification

DVMPh.D.Product development experienceGCP/GLP/GMP knowledgeClinical program strategyRegulatory complianceCommunication skillsOrganizational skillsMotivation

Required

A DVM or a Ph.D. in an animal health related field is preferred. An MS with experience will be considered
A minimum of 5 years of experience in product development within or closely associated with the pharmaceutical industry is preferred
Outstanding organization, motivation and communication: ability to organize and manage a variety of projects at any one time demonstrating strict attention to detail; self-motivated and able to work and learn without direct supervision
Current knowledge of all pertinent global / national / federal regulations under which therapeutic products are evaluated

Preferred

Basic understanding of research and development processes
Acting as strategist and facilitator to drive clinical programs
Good understanding and working knowledge of GCP/GLP/GMP and quality; proven experience working with regulatory authorities
Demonstrated ability to work with external partners
Experience and displayed achievements within the key competencies of Strategic Mindset, Business Insight, Cultivating Innovation, and Driving a Vision

Benefits

Multiple relocation packages
Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)
8-week parental leave
9 Employee Resource Groups
Annual bonus offering
Flexible work arrangements
Up to 6% 401K matching

Company

Elanco is an animal health company that manufactures and markets a diverse range of products to promote animal health and well-being.

H1B Sponsorship

Elanco has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (9)

Funding

Current Stage
Public Company
Total Funding
$252.86M
Key Investors
AncoraBill & Melinda Gates Foundation
2023-12-30Post Ipo Equity· $250M
2018-09-19IPO
2017-05-24Grant· $2.86M

Leadership Team

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Dave Kinard
Executive Vice President Human Resources, Corporate Affairs & Administration
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Justine Conway
Global Head of Business Development and External Innovation
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Company data provided by crunchbase