SR Scientist, Clinical - Study Lead

Boehringer Ingelheim • Ames, IA

1d

About The Position

The Senior Scientist, Clinical is responsible for establishing the safety and efficacy of new animal pharmaceutical and biological products, line extensions, and existing licensed products. The role designs and implements clinical studies, including resource and budget planning, from protocol development through execution and final reporting for regulatory submissions, in both laboratory and field settings. The position serves as a clinical subject matter expert and representative throughout product development, including on development teams and in regulatory authority meetings, and ensures compliance with applicable regulatory and animal-welfare principles.

The incumbent may lead a Clinical Team and develop and implement clinical strategy, serving as the clinical representative on a multidisciplinary Core Team. The role is responsible for study design, execution, analysis, and reporting; clinical program progress, timelines, deliverables, and budgets; and clinical input to product profiles and project decisions. It also involves collaboration with internal and external stakeholders, development of external providers and research partnerships, mentoring and coaching colleagues, and potentially managing scientific staff.

Requirements

• One of the following: DVM and five years of related experience; PhD in a veterinary-relevant field (such as parasitology or animal nutrition) and five years of related experience; or a master's degree in a veterinary-relevant field and ten years of related experience.
• A proven track record of successfully implementing or investigating technologies and adding value to an organization, or an equivalent combination of education and experience.
• At least five years of broad related experience.
• Analytical thinking and strong ability to understand data and scientific decision processes, interpret results, and report well-supported conclusions tied to project objectives.
• Strong leadership skills and ability to lead teams without formal authority.
• Research methodology experience.
• Ability to foster innovation and solve problems.
• Strong communication and interpersonal skills, including effective oral and written communication in interdisciplinary and international environments.
• Collaborative, customer-service-oriented approach, with the ability to deliver results and execute quickly and effectively.
• Exceptional planning and organizational skills and a quality orientation.
• Accountability, ownership, integrity, and trustworthiness.
• Fluent English reading, writing, and speaking skills.
• One to three years of project leadership experience.
• Demonstrated knowledge of the product life-cycle process and experience in project or program management.
• Business and technical knowledge.
• Willingness to travel 10–20%, including overnight travel.
• 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 at least 18 years of age.

Nice To Haves

• Board certification and/or an advanced degree (MS or PhD) in addition to a DVM.
• Clinical veterinary practice experience.

Responsibilities

• Initiate and coordinate strategic scientific experiments with defined goals, including developing methodologies, protocols, and test procedures.
• Lead overall study design, execution, and reporting to meet project milestones.
• Design clinical studies to support label claims and product licenses or marketing authorizations in alignment with the TPP, global regulatory guidance, data-integrity requirements, and animal-welfare standards.
• Direct or oversee study design and analysis performed by junior scientists as needed.
• Provide subject-matter expertise, guidance, and technical input to projects and evaluate technologies and concepts.
• Keep abreast of relevant literature; publish in peer-reviewed journals and present research at meetings as requested.
• Interact scientifically with Key Opinion Leaders and build visibility outside the functional area.
• Collaborate across functions and with external stakeholders to deliver clinical plans and improve study processes, quality, speed, and value.
• Develop and leverage external providers, academia, and Contract Research Organizations as needed.
• Mentor, coach, and train colleagues, particularly clinical research associates and monitors, on study execution, compliance, and collaborative practices.
• Recruit, manage, mentor, and develop scientific staff if direct reports are assigned.
• Provide safety and efficacy content for regulatory submissions, lead clinical discussions with regulatory authorities, and/or develop clinical and regulatory strategy.
• Develop clinical strategy and work toward project goals defined in the TPP.
• Lead or represent clinical programs on multidisciplinary project teams and interact with Project Leaders, team members, and stakeholders.
• Manage clinical project progress, timelines, deliverables, and budgets.
• Communicate risks and changes to the RTP or TPP to the project team and provide clinical veterinary and scientific input to those profiles.
• Take on Clinical Lead, Study Director, Monitor, and Investigator roles as needed.
• Design, organize, conduct, complete, and report assigned clinical R&D studies to establish safety and efficacy and develop new claims or uses for existing products.
• Ensure compliance with GSP, GLP, GCP, pharmacovigilance, animal-welfare, and local regulatory requirements.
• Contribute to or lead internal initiatives such as SOP development, patent filings, and due diligence.

Benefits

• Competitive compensation and benefit programs.
• Support for a healthy working environment, meaningful work, mobility, networking, and work-life balance.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior