Sr Manager Clinical Research

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.

Our Neuromodulation business is an area of expertise for Abbott. This business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders. Our deep brain stimulation technology for progressive diseases help people manage their Parkinson’s disease and essential tremor symptoms, steering away from side effects.
 

THE OPPORTUNITY
 

Senior Manager, Clinical Research
 

We have an exciting opportunity for the right candidate to join our rapidly growing clinical team within Abbott Neuromodulation. The job purpose and scope of the Senior Manager, Clinical Research is to lead clinical evidence generation activities associated with Neuromodulation products, primarily within the DBS therapies for movement disorders and psychiatric disorders. This position will work closely within the cross-functional clinical study team including project management, medical affairs, biometrics, data management, and other clinical study personnel in addition to working directly with physician leaders and study investigators. This position will have significant interaction with executive leadership, physicians and regulatory authorities.
 

Description of Job Scope
 

This position will:

· Manage and lead the clinical evidence generation for DBS products including the design and conduct of clinical studies, from prospective pre-market and post market studies to RWE data generation.

· Lead the process of clinical evidence generation for medical devices, by collaborating closely with the statistician, medical affairs, and regulatory affairs personnel, that appropriately satisfy the needs of the business as determined by marketing and reimbursement organizations

· Provide scientific justification to trial design and ongoing scientific analyses during protocol development and provide scientific guidance to the development of statistical analyses plans

· Contribute to the scientific analyses, presentation, and interpretation of clinical data generated from Abbott sponsored clinical studies.

· Synthesize literature and competitive information across multiple products and/or therapies within the assigned therapeutic area

· Lead study level (and franchise level where applicable) publication planning, and ensure successful execution of the publication plan

· Collaborate closely with external stakeholders including physician investigators and key opinion leaders, and successfully represent Abbott as the primary scientific expert for the therapy

· Generate clinical strategy and documents to support pre and post market regulatory medical devices submissions for Abbott products and/or respond to questions from regulatory authorities about existing submissions

· Lead publications for clinical study data through coordination with investigator authors and project management of reviews and revisions for abstracts and manuscripts

· Contribute to the optimization of internal processes and workflows

· Participation in and oversight of scientific report writing. Presentation of methods, results and conclusions to a publishable standard.

· Contribution to planning and execution of collaborative projects with leading academic and commercial research groups worldwide.

· Develop new ideas for both external and internal projects.

· Attend and prepares for meeting with global regulatory agencies involving clinical data.
 

Accountability Scope and Budget
 

· Understands busine