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 109,000 colleagues serve people in more than 160 countries.

ABOUT ABBOTT DIAGNOSTICS

The key to successful treatment and full recovery is often fast, accurate diagnosis. Abbott’s life-changing tests and diagnostic tools provide insights that enable smarter, faster decisions and transform the way the world is managing health.

Our pioneering technology spans the world of healthcare operations — with medical diagnostic instruments, tests, automation and informatics solutions for hospitals, reference labs, blood centers, emergency departments, physician offices and clinics.

Our location in Lake County, Illinois currently has an opportunity for a Senior Director, Global Medical Affairs within our Transfusion Medicine business unit.  

WHAT YOU’LL DO 

The Senior Director, Global Medical Affairs serves as the primary internal resource for medical and scientific guidance across current and future product lines.   Responsible for managing the Transfusion Medicine business unit’s medical, clinical and scientific affairs organization with the primary purpose to provide in depth medical & scientific support to the company's cross functional development and execution teams (clinical, regulatory, R&D, marketing, sales and quality).  The director will serve as a medical resource and content expert supporting a broad internal and external audience and will collaborate across functions to craft, integrate and implement robust, contemporary and clear clinical trial strategies.  

The Senior Director, Global Medical Affairs may be responsible for the following activities:

• As a subject matter expert, develop and maintain current standards of care knowledge base relevant to medical and technology trends in the designated therapeutic areas; understand core medical and scientific literature related to the clinical applications of products and utilize this to respond to internal and external customer queries, as appropriate.

• Collaborate directly with R&D, manufacturing and quality functions to acquire product life cycle knowledge and integrate an effective product application into clinical trials; collaborate with commercial stakeholders to ensure the clinical development strategy is in line with ultimate commercial positioning of the product.

• Consult with external KOL’s to influence and guide the development of appropriate treatment protocols.

• Provide medical and scientific direction in the preparation and submission of worldwide regulatory dossiers as well as serve as the medical / scientific representative at regulatory meetings as appropriate.

• Write / design initial clinical strategy and concept summaries, clinical trial protocols, investigator’s brochures.  Instruct / guide and oversee supporting clinical, technical and statistical contributors on the development of said protocols, investigator’s brochures and clinical study reports. Approve all final clinical trial protocols, investigator brochures and revisions, and relevant medical / scientific sections of regulatory submissions.

• Responsible for development, implementation and oversight of an internal medical monitoring process for all clinical trial adverse event reporting and event committees.

• Work with product development and marketing teams to define the requirements and specifications for new products.

• Develop, implement and oversee internal medical monitoring process to include adverse event reporting and review procedures, development of clinical events committee and data safety monitoring board operational procedures to ensure consistency and compliance with regulatory standards and / or FDA expectations

• Assess promotional materials to ensure that all claims are fully supported by scientific data and are presented in an accurate, fair, and balanced manner

• Review training documents to check medical accuracy and compliance with regulatory requirements

• Serve as medical expert contributor and work with customer service and assist with investigation and analyzing product complaints that have resulted in adverse clinical consequences

• Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.  Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

EDUCATION AND EXPERIENCE YOU’LL BRING

Required:

• Bachelor’s degree required; MD strongly preferred.  

• Minimum 10 years of related work experience

• Background in medical affairs and clinician education. 

• Sound medical understanding of human anatomy and physiology as it relates to the company’s product profile. Additionally, should have an understanding of pharmacokinetics, metabolism and drug interactions. 

• Comprehensive understanding of the medical device development process. 

• Proven expertise in the writing, review, and editing of clinical and non-clinical research protocols including trial design and methodology. 

Preferred:

• Transfusion Medicine Board Certification preferred.

• Experience working in a broader enterprise/cross-division business unit model preferred.

• Ability to work in a highly matrixed and geographically diverse business environment.

• Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results.  

• Ability to work effectively within a team in a fast-paced changing environment.

• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.

• Multi-tasks, prioritizes and meets deadlines in timely manner.

WHAT WE OFFER

• At Abbott, you can have a good job that can grow into a great career. We offer:
• Training and career development, with onboarding programs for new employees and tuition assistance
• Financial security through competitive compensation, incentives and retirement plans
• Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
• Paid time off
• 401(k) retirement savings with a generous company match
• The stability of a company with a record of strong financial performance and history of being actively involved in local communities

Learn more about our benefits that add real value to your life to help you live fully:  www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.