Senior Scientist, Clinical

Responsible for the safety and efficacy in the target species for new 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 both lab and field 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.

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 collaborate 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.
• Mentor, coach and train colleagues, especially 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.
• Provide 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.
• The individual 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.
• Ensures that risks and changes to the Target Product Profile (TPP) are communicated into the project team.
• The individual provides clinical input to the TPP and influences the Project from the clinical veterinary and scientific perspective.
• Takes on Study Director, Monitor and Investigator roles as necessary.
• 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 pharmaceuticals, and to develop new claims and uses for existing products.
• Ensures compliance in the area of GLP, GCP, PV, animal welfare and local regulatory requirements. Study Director responsibilities are described in the applicable GLP standards.
• Contribute or lead internal initiatives such as SOP development, patent filings and due diligence.
• Complies with all applicable regulations governing the Animal Health Industry (GCP, GLP, Animal Welfare, Regulatory requirements, etc).
• Ensures that work performed in area of responsibility is conducted in a safe and compliant manner.
• Maintains proper records in accordance with SOPs and policies.