Senior Clinical Research Scientist

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

     

JOB DESCRIPTION:

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our Austin, TX location in the Neuromodulation Division.  The job purpose and scope of the Senior Clinical Research Scientist is to author the scientific documents to support pre and post market clinical evidence generation associated with Neuromodulation products, primarily within the DBS therapies for movement disorders and psychiatric disorders. This position will work closely within cross-functional project teams including project management, regulatory affairs, marketing, medical affairs, biometrics, data management, and clinical operations in addition to supporting interactions with physician leaders and study investigators.

What You’ll Work On

• Generate scientific content required for the design and conduct of clinical studies, from prospective pre-market and post market studies to RWE data generation, including but not limited to: authoring clinical trial protocols, case report forms, informed consent forms, report of prior investigations, and investigator brochures.
• Collaborate closely with statistics, medical affairs, and regulatory affairs personnel to accomplish goals that appropriately satisfy the needs of the business as determined by regulatory agencies and reimbursement organizations.
• Provide scientific justification to evidence generation for medical devices and ongoing scientific analyses during protocol development and provide scientific guidance to the development of statistical analysis plans.
• Synthesize literature across multiple products and/or therapies within the assigned therapeutic area
• Collaborate closely with external stakeholders including physician investigators and key opinion leaders, and successfully represent Abbott as a scientific expert for the assigned therapy.
• Author documents to support pre-market regulatory submissions and post-market regulatory requirements for Abbott products and/or respond to questions from regulatory authorities about existing submissions.
• Author publications for clinical study data through coordination with investigator authors and project management of reviews and revisions for abstracts and manuscripts.
• Attend and prepares for meeting with global regulatory agencies involving clinical data.

Required Qualifications

• Associates degree and minimum 4 years of related work experience
• Ability to work in a highly matrixed and geographically diverse business environment
• Strong verbal and written communication skills and interpersonal skills
• This position also requires strong leadership skills as it will require significant interaction with executive leadership, physicians and regulatory authorities

Preferred Qualifications

• PhD in biomedical engineering, biological sciences, biostatistics, or related field or MS in a related field and relevant research experience
• 1+ years of related clinical research for medical devices
• In-depth knowledge of movement disorders, brain therapies, depression or other psychiatric disorders or neuromodulation t