Boehringer Ingelheim Pharmaceuticals, Inc

SR Scientist, Clinical

Boehringer Ingelheim Pharmaceuticals, Inc • $90K — $120K *
Fulton, KY 42041In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
1 month ago
Job Overview by Ladders

Qualifications

  • DVM or equivalent advanced degree in a veterinary-relevant field required.
  • 5-10 years of experience in pharmaceutical research or related industry.
  • Strong understanding of research methodologies and clinical study design.
  • Proven track record in implementing technologies that enhance organizational value.
  • Exceptional leadership and communication skills.

Responsibilities

  • Initiate and oversee scientific experiments to support innovation.
  • Design and execute clinical studies aligned with regulatory standards.
  • Lead clinical teams through all stages of product development.
  • Publish research findings and present at scientific gatherings.
  • Collaborate across functions to optimize study delivery and compliance.

Benefits

  • Mentorship and training opportunities for professional development.
  • Engagement with Key Opinion Leaders in the industry.
  • Opportunity to lead projects without formal authority.
  • Exposure to regulatory processes and compliance standards.
  • Possibility of travel to national and international meetings.
Full Job Description
Description

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.
  • Provides technical content (safety and efficacy data) for local and international regulatory submissions and/or leads clinical discussions in authority meetings and/or develops clinical and regulatory strategy.
  • Develops the clinical strategy and works effectively toward achieving the project goals as defined in the TPP.
  • Assumes leadership (as the clinical leader or clinical representative) for clinical programs within multi-disciplinary Project Teams for the effective research and development of pharmaceutical projects.
  • Interacts with Project Leaders, members of the Project Teams and stakeholders.
  • Responsible for clinical project progress, including timelines, deliverable and budgetary responsibilities.


Requirements

  • DVM preferred with 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 required.

OR
  • PhD (with significant experience in a veterinary-relevant field such as parasitology or animal nutrition) with 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 required.

OR
  • Master's Degree (with significant experience in a veterinary-relevant field such as parasitology or animal nutrition) with 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 required.
  • Board Certification and/or advanced degree (MS or PhD) in addition to DVM is a plus.
  • Clinical veterinary practice experience is preferred.
  • Interest in developing therapeutics a plus.
  • Minimum of five years (5) 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.
  • Demonstrates industry-leading knowledge of field.
  • An analytical thinker.
  • 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.
  • Research methodology experience.
  • Fosters innovation.
  • A problem solver.
  • Outstanding / Good communication and interpersonal skills.
  • A collaborative team player.
  • 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.
  • Willingness to travel (>10% annual travel).
  • English: Fluent (read, write and speak).
  • Ability to communicate effectively both orally and in writing in an inter-disciplinary and international environment.
  • Leadership experience: One to three (1-3) years leading projects.
  • Demonstrated knowledge of the product life cycle process.
  • Experienced in project/program management.
  • Exhibits business and technical knowledge.


Desired Skills, Experience and Abilities

Additional Duties & Responsibilites :
  • Ensures that risks and changes to either the Research Target Profile (RTP) or Target Product Profile (TPP) are communicated into the project team.
  • Provides clinical input to the either RTP or TPP and influences the Project from the clinical veterinary and scientific perspective.
  • Takes on Clinical Lead, Study Director, Monitor and Investigator roles as necessary.
  • Responsible for the design, organization, conduct, timely completion and reporting of assigned clinical R&D studies to establish safety and efficacy of new pharmaceuticals, and to develop new claims and uses for existing products.
  • Ensures compliance around GSP, GLP, GCP, PV, animal welfare and local regulatory requirements.
  • Study Director responsibilities are described in the applicable GLP standards.
  • Contributes or leads internal initiatives such as SOP development, patent filings and due diligence.

About Boehringer Ingelheim Pharmaceuticals, Inc

Boehringer Ingelheim Pharmaceuticals, Inc. is a research-driven pharmaceutical company that discovers, develops, and manufactures prescription medicines. The company's mission is to improve the health and quality of life of patients by developing innovative therapies. Boehringer Ingelheim Pharmaceuticals, Inc. is a subsidiary of Boehringer Ingelheim Corporation, which is headquartered in Ingelheim, Germany. The company's research and development efforts focus on respiratory diseases, immunology, oncology, and diseases of the central nervous system. Boehringer Ingelheim Pharmaceuticals, Inc. was founded in 1885 and is based in Ridgefield, Connecticut.
Learn more about Boehringer Ingelheim Pharmaceuticals, Inc
Size
5,000 employees
Industry
Pharmaceuticals & Biotech
* Ladders Estimates

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