SR Scientist, Clinical - Study Lead

Boehringer Ingelheim; Ames (IA); On-site; USD 120,000 - 180,000; Full time

Job summary

The Senior Scientist, Clinical at Boehringer Ingelheim ensures safety and efficacy in target species for animal pharma projects, from protocol to final study report for regulatory submissions. It covers study design, resource and budget planning, and collaboration with regulatory authorities and key stakeholders.

The role may lead a Clinical Team, advance the clinical strategy, and mentor colleagues while maintaining compliance with regulatory and animal welfare standards across lab and field

Qualifications

• Designs and oversees clinical studies to meet project milestones.
• Coordinates strategic experiments and data analysis with junior scientists.
• Ensures compliance with global regulatory guidance and animal welfare principles.

Responsibilities

• Designs clinical studies to earn label claims and licenses.
• Represents clinical content to regulatory authorities and leads discussions.
• Mentors clinical staff on best practices for study execution and compliance.

Job description

Description

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 several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

The Senior Scientist, Clinical is responsible for the safety and efficacy in the target species for new animal pharmaceutical and biological research and development projects, line extensions and maintaining existing licensed products. This role 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 and biological projects in both lab and field conditions. The incumbent 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).

The Senior Scientist, Clinical acts as the Clinical Representative as assigned for all stages of product development. This role resents 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.

Duties & Responsibilities

• Independently initiates and coordinates 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 overall study design, execution, and reporting to achieve project milestones
• Designs 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
• May direct and oversee experimental study design and data analysis/results of junior-level scientists
• Demonstrates expertise in a specific project-relevant area or technology
• May provide guidance and expertise to advance specific projects or evaluate and propose new technologies and concepts in support of multiple projects
• Keeps abreast of relevant literature
• Develops visibility outside of functional area and effectively interacts scientifically with Key Opinion Leaders in relevant fields of research
• Publishes research in peer reviewed journals and presents data at national/international meetings as requested
• Skillfully collaborates across functions (internal and external stakeholders) 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 & suitability, monitoring effectiveness, statistical analysis, study event tracking, compliance, and excellent reporting
• Develops and leverages external providers, academia and Contract Research Organizations as necessary
• Mentors, coaches, and trains colleagues, especially clinical research associates/monitors, on best practices for study execution with flawless speed and compliance, professional & collaborative team member behaviors, accountability, and alignment within Pharma Clinical and with all stakeholders
• Assumes responsibility for direct reports, if assigned and as needed, including recruiting, managing, mentoring and developing scientific staff
• Provides technical content (safety and efficacy data) for local and international regulatory submissions and/or leads clinical discussions in authority meetings and