Scientist IV, Clinical - Boehringer Ingelheim
Fulton, MO
About the Job
Description
Responsible for the safety and efficacy in the target species for new animal research and development projects, line extensions and maintaining existing licensed products. Provides clinical study design and implementation, and assists with resource and budget planning from protocol to execution and to final study report for submission to regulatory agencies for animal studies in both lab and field conditions. Acts as the Clinical Representative as assigned for all stages of product development (from research to marketing support). Supports the presentation of clinical content to regulatory authorities as required and ensures compliance with all applicable regulatory and animal welfare principles. The incumbent is part of a Clinical Team as Clinical representative and supports the development and implementation of the clinical strategy.
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
+ Assists in the initiation and coordination of 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. Supports overall study design, execution, and reporting to achieve project milestones.
+ Key member of teams that design clinical studies to earn label claims and new product licenses/marketing authorizations consistent with the TPP and in compliance with global regulatory guidance and corporate standards for data integrity and animal welfare.
+ Collaborate across functions (internal and external stakeholders) to ensure activities for Clinical 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 ' suitability, monitoring effectiveness, statistical analysis, study event tracking, compliance, and excellent reporting. Supports in the development and management of external providers, academia and Contract Research Organizations as necessary.
+ Helps providing technical content (safety and efficacy data) for local and international regulatory submissions and/or supports clinical discussions in authority meetings and/or assists in the development of clinical and regulatory strategy.
+ Takes on Monitor and Investigator roles as necessary. Key member of teams responsible for the design, organization, conduct, timely completion and reporting of assigned clinical R'D studies in order to establish safety and efficacy of new products, develop new claims and uses for existing products. Ensures compliance in the area of GLP, GCP, PV, animal welfare and local regulatory requirements.
+ Contribute or lead internal initiatives such as SOP development, patent filings and due diligence.
Requirements
+ DVM strongly preferred from an accredited institution with previous experience in related Research ' Development field.
+ In lieu of DVM, will accept PhD from an accredited institution with experience in a veterinary-relevant field such as parasitology or animal nutrition.
+ In lieu of DVM or PhD, will accept a Masters Degree from an accredited institution with experience in a veterinary-relevant field such as parasitology or animal nutrition, plus (three (3) years of experience in a related field with track record.
+ Research methodology experience.
+ Clinical veterinary practice experience is preferred.
+ Previous experience with clinical and laboratory/field studies (GxP and non-GxP) is a plus.
+ Basic understanding of claim structure of veterinary pharmaceutical products.
+ Able to effectively work in an international and cross-functional matrix environment.
+ Knowledge of regulatory requirements (e.g. FDA, EMA) and compliance.
+ Experience with planning, conducting, reporting, analyzing and interpreting clinical studies.
+ Basic understanding of statistical principles in clinical studies.
+ Good skills in understanding data and scientific decision processes, and in interpreting and reporting these data in well supported conclusions targeted at achieving study/project objectives.
+ Willingness to travel.
Desired Skills, Experience and Abilities
+ Previous experience in veterinary research ' development is desired.
Eligibility Requirements:
+ Must be legally authorized to work in the United States without restriction.
+ Must be willing to take a drug test and post-offer physical (if required).
+ Must be 18 years of age or older.
All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
Responsible for the safety and efficacy in the target species for new animal research and development projects, line extensions and maintaining existing licensed products. Provides clinical study design and implementation, and assists with resource and budget planning from protocol to execution and to final study report for submission to regulatory agencies for animal studies in both lab and field conditions. Acts as the Clinical Representative as assigned for all stages of product development (from research to marketing support). Supports the presentation of clinical content to regulatory authorities as required and ensures compliance with all applicable regulatory and animal welfare principles. The incumbent is part of a Clinical Team as Clinical representative and supports the development and implementation of the clinical strategy.
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
+ Assists in the initiation and coordination of 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. Supports overall study design, execution, and reporting to achieve project milestones.
+ Key member of teams that design clinical studies to earn label claims and new product licenses/marketing authorizations consistent with the TPP and in compliance with global regulatory guidance and corporate standards for data integrity and animal welfare.
+ Collaborate across functions (internal and external stakeholders) to ensure activities for Clinical 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 ' suitability, monitoring effectiveness, statistical analysis, study event tracking, compliance, and excellent reporting. Supports in the development and management of external providers, academia and Contract Research Organizations as necessary.
+ Helps providing technical content (safety and efficacy data) for local and international regulatory submissions and/or supports clinical discussions in authority meetings and/or assists in the development of clinical and regulatory strategy.
+ Takes on Monitor and Investigator roles as necessary. Key member of teams responsible for the design, organization, conduct, timely completion and reporting of assigned clinical R'D studies in order to establish safety and efficacy of new products, develop new claims and uses for existing products. Ensures compliance in the area of GLP, GCP, PV, animal welfare and local regulatory requirements.
+ Contribute or lead internal initiatives such as SOP development, patent filings and due diligence.
Requirements
+ DVM strongly preferred from an accredited institution with previous experience in related Research ' Development field.
+ In lieu of DVM, will accept PhD from an accredited institution with experience in a veterinary-relevant field such as parasitology or animal nutrition.
+ In lieu of DVM or PhD, will accept a Masters Degree from an accredited institution with experience in a veterinary-relevant field such as parasitology or animal nutrition, plus (three (3) years of experience in a related field with track record.
+ Research methodology experience.
+ Clinical veterinary practice experience is preferred.
+ Previous experience with clinical and laboratory/field studies (GxP and non-GxP) is a plus.
+ Basic understanding of claim structure of veterinary pharmaceutical products.
+ Able to effectively work in an international and cross-functional matrix environment.
+ Knowledge of regulatory requirements (e.g. FDA, EMA) and compliance.
+ Experience with planning, conducting, reporting, analyzing and interpreting clinical studies.
+ Basic understanding of statistical principles in clinical studies.
+ Good skills in understanding data and scientific decision processes, and in interpreting and reporting these data in well supported conclusions targeted at achieving study/project objectives.
+ Willingness to travel.
Desired Skills, Experience and Abilities
+ Previous experience in veterinary research ' development is desired.
Eligibility Requirements:
+ Must be legally authorized to work in the United States without restriction.
+ Must be willing to take a drug test and post-offer physical (if required).
+ Must be 18 years of age or older.
All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
Source : Boehringer Ingelheim