- Formulate comprehensive clinical development plans for each new product. Build effective relationships within and outside Research and Development (Portfolio and Project Leadership, Regulatory Affairs and Pharmacovigilance, Clinical Development Sciences (CDS), R&D Quality Assurance, Marketing, Manufacturing and Quality) during development of products and life cycle management to assure that all parties involved meet critical deadlines and deliver work with appropriate quality attributes (GCP, GLP).
- Specific duties include executing individual clinical programs. In cooperation with other teams ( CDS, Biostatistics, Regulatory Affairs), design and write protocols for laboratory and field efficacy studies and TAS to generate information that will lead to regulatory approval of products. Work cooperatively with CDS to select suitable research facilities and qualified researchers to execute protocols. Coordinate with other teams to ensure study monitoring according to current applicable regulations, company policies, and management expectations. With support from other teams ( Data Management, Medical Writing, Biostatistics, and internal / external SME reviewers), analyze and interpret results and author study reports. Work collaboratively with Regulatory Affairs to prepare reports and data for submission to regulatory agencies and present data to regulatory authorities and/or scientific meetings.
- Ensure quality assurance/regulatory compliance and participate and/or lead administrative and procedural activities such as development of new processes and / or functional procedures.
- Attend scientific meetings, continuing education courses and keep abreast of scientific advances and new developments in the animal health industry and veterinary profession.
- A DVM or a in an animal health related field is preferred. An MS with experience will be considered.
- Five or more years of experience in product development within or closely associated with the pharmaceutical industry is preferred.
- The incumbent must possess the ability to organize and manage a variety of projects at any one time demonstrating strict attention to detail.
- Current knowledge of all pertinent global / national / federal regulations under which therapeutic products are evaluated is desired.
- A working knowledge of word processing and spreadsheet computer programs is also necessary.
- The incumbent must be self-motivated and able to work and learn without direct supervision.
- Excellent communication skills are required.
- Basic understanding of research and development processes
- Acting as strategist and facilitator to drive clinical programs
- Proven experience working with regulatory authorities
- Good understanding and working knowledge of GCP/GLP/GMP and quality
- Demonstrated ability to work with external partners
- Experience and displayed achievements within the key competencies of Strategic Mindset, Business Insight, Cultivating Innovation, and Driving a Vision
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Senior Research Scientist - Monheim, Deutschland - Elanco
Beschreibung
At Elanco (NYSE: ELAN) – it all starts with animals
As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We're driven by our vision of 'Food and Companionship Enriching Life' and our approach to sustainability – the Elanco Healthy Purpose – to advance the health of animals, people, the planet and our enterprise.
At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you'll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.
Making animals' lives better makes life better – join our team today
Position Description:
Conduct and coordinate the development of global Pet Health clinical development programs (effectiveness, TAS) from their inception through approval in initial target geographies.
Reporting to the Clinical Leader, the incumbent will have the opportunity to design and execute studies that will deliver Elanco's innovation pipeline to customers.
Functions, Duties, Task:
The primary purpose of this position is the development of new pet health therapeutic products by planning, coordinating, implementing, and reporting high quality clinical effectiveness and target animal safety (TAS) programs. Specifically, planning and executing pilot and pivotal studies in compliance with global regulatory standards (including GLP, vGCP & VICH) and guidelines. Authoring of study protocols and reports, selecting internal sites or Contract Research Organizations (CROs) to conduct studies, coordination, and managing studies are also included.
Minimum Qualification (education, experience and/or training, required certifications):
Additional Preferences:
