Sr Scientist, Clinical
Description
Responsible for the safety and efficacy in the Avian vaccine and Companion animal pharmaceutical research and development projects, line extensions and maintaining existing licensed products. Provides clinical study design and implementation including resource and budget planning from protocol to execution and to final study report for submission to regulatory agencies for animal pharmaceutical projects in lab conditions. Fulfills a role as a subject matter expert in representing his/her function (e.g. on development teams, regulatory authority meetings and key Opinion Leaders). Acts as the Clinical Representative as assigned for all stages of product development. Presents clinical content to regulatory authorities as required and ensures compliance with all applicable regulatory and animal welfare principles. The incumbent may lead a Clinical Team as Clinical Leader and is responsible for development and implementation of the clinical strategy. The Clinical Leader serves as the representative on the Core Team. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
Duties & Responsibilities
• Demonstrate expertise in Avian vaccine development and studies, Companion animal vaccine, and animal pharmaceutical development.
• May provide guidance and expertise to advance specific projects or evaluate and propose new technologies and concepts in support of multiple projects. Keep abreast of relevant literature.
• Independently initiate and coordinate strategic scientific experiments with a predefined goal including developing new methodologies, protocols and/or test procedures that contribute to innovation and core group/research goals and reflect expert knowledge. Responsible for the design, organization, conduct, timely completion and reporting of assigned clinical recherche and development studies to earn label claims and new product licenses/marketing authorizations consistent with the Target Product Profile, and to develop new claims and uses for existing products. Take on Study Director, Monitor and Investigator roles as necessary.
• Ensure compliance in the area of Good Laboratory Practice, Good Clinical Practice, Pharmacovigilance, animal welfare, and local and global regulatory requirements.
• Develop visibility outside of functional area and effectively interact scientifically with Key Opinion Leaders in relevant fields of research. Publish research in peer reviewed journals and present data at national/international meetings as requested.
• Skillfully collaborate across functions to assure clinical plans and activities for project teams are delivered efficiently, while supporting continuous improvement in quality including, speed and value of processes supporting studies including protocol and forms, test article availability and suitability, monitoring effectiveness, statistical analysis, study event tracking, compliance, and excellent reporting.
• Develop and leverage external providers, academia and Contract Research Organizations as necessary.
• Mentor, coach and train colleagues, especially research associates/monitors/biologists, on best practices for study execution with flawless speed and compliance, professional and collaborative team member behaviors, accountability, and alignment within Clinical and with all stakeholders.
• Responsible for progress of clinical studies, including timelines, deliverable and budgetary responsibilities. Ensure that risks and changes to the Target Product Profile are communicated into the project team. Provide clinical input to the Target Product Profile and influence the Project from the clinical veterinary and scientific perspective.
Requirements
• DVM or PhD from an accredited institution plus five (5) years of experience in a related field with a proven track record of successfully implementing or investigating technologies and adding value to the organization.
• In lieu of DVM, will accept PhD from an accredited institution with significant experience in a veterinary-relevant field such as parasitology or animal nutrition, plus five (5) years of experience in a related field with a proven track record of successfully implementing or investigating technologies and adding value to the organization.
• In lieu of DVM or PhD, will accept a Masters Degree from an accredited institution with significant experience in a veterinary-relevant field such as parasitology or animal nutrition, plus ten (10) years of experience in a related field with a proven track record of successfully implementing or investigating technologies and adding value to the organization.
• Board Certification and/or advanced degree (MS or PhD) in addition to DVM is a plus.
• A minimum of five (5) years of broad experience in a related field with a proven track record of successfully implementing or investigating technologies and adding value to the organization or equivalent combination of education and experience.
• Considerable experience (greater than three 3 years) in veterinary research ' development.
• Experienced in project/program management; one to three (1-3) years leading projects.
• Hands-on experience with clinical and laboratory/field studies (GxP and non GxP)
• Experience in analyzing literature and technology trends in the veterinary and pharmaceutical industry.
• Experience with planning, conducting, reporting, analyzing and interpreting clinical studies.
• Research methodology experience.
• Clinical veterinary practice experience is preferred.
• Solid / basic understanding of claim structure of veterinary pharmaceutical products including sound knowledge of the veterinary business environment and how clinical design impacts label language and commercial value of a product.
• Able to effectively work in an international and cross-functional matrix environment
• Knowledge of global regulatory requirements (e.g. FDA, EMA) and compliance.
• Basic understanding of statistical principles in clinical studies.
• Understands principles of clinical risk assessment and risk mitigation.
• Excellent skills in understanding data and scientific decision processes, and in interpreting and reporting these data in well supported conclusions targeted at achieving project objectives.
• Strong leadership skills. Able to lead (e.g. the Clinical team) without formal authority.
• Outstanding / Good communication and interpersonal skills.
• A collaborative team player.
• Values diversity and inclusion.
• Possesses a customer service orientation, delivering results and executing in a fast and focused manner.
• Exceptional planning and organizational skills with a quality orientation. Strives for business process excellence.
• Accepts accountability and ownership.
• Exhibits integrity and trust.
• English: Fluent (read, write and speak)
• Demonstrates industry-leading knowledge of field.
• Demonstrated knowledge of the Pharmaceutical life cycle process.
• Exhibits business and technical knowledge.
• Willingness to travel up to 5 - 15%
Pharmaceutical Manufacturing
Research, Analyst, and Information Technology
Full-time