SR Scientist, Clinical - Study Lead

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
• 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/or develops clinical and regulatory strategy
• 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, deliverables and budgetary responsibilities

Requirements

• DVM 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
• 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
• Clinical veterinary practice experience is preferred
• English: Fluent (read, write and speak)
• Board Certification and/or advanced degree (MS or PhD) in addition to DVM is 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
• Demands industry-leading knowledge of field
• 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
• Experienced in project/program management
• Exhibits business and technical knowledge