Associate Director Clinical Strategy
Abbott
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.
**Working at Abbott**
At Abbott, you can do work that matters, grow, and learn, care for yourself and your 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.
+ Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
+ An excellent retirement savings plan with a high employer contribution
+ Tuition reimbursement, the Freedom 2 Save (https://www.abbott.com/corpnewsroom/strategy-and-strength/tackling-student-debt-for-our-employees.html) student debt program, and FreeU (https://www.abbott.com/corpnewsroom/strategy-and-strength/college-degree-for-free-its-possible-with-freeu.html) 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 worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists.
**The Opportunity**
This position works out of our **Lake Forest, IL location daily on site** within the Medical, Clinical & Scientific Organization (MCSO) function of the **Rapid Diagnostics Infectious Disease** business unit.
We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people.
**What You’ll Work On**
Clinical Leadership:
+ Ensure adequate resources with the necessary experience, education, and training.
+ Keep the clinical department updated on current domestic and international regulations.
+ Manage projects to meet timelines and budgets.
+ Engage with Key Opinion Leaders to set performance targets and clinical requirements.
+ Coordinate with internal stakeholders to keep studies on track.
+ Serves as a medical/scientific consultant to marketing and functions within the Product Divisions.
+ Monitors and/or interprets results of clinical investigations in preparation for IVD device applications.
Strategic Direction:
+ Align clinical research with the business strategic plan.
+ Define clinical considerations for new assay development and changes.
+ Provide strong clinical/scientific support to projects.
+ Identify and promote strategies for improved research quality and best practices.
+ Assess project progression and develop strategic responses.
+ Contribute to all stages of product planning to ensure that product design goals are consistent with an optimized sponsor-initiated clinical strategy.
Clinical Data Management:
+ Direct the interpretation of clinical results and preparation of study summaries.
+ Provide strategic input for publications, presentations, and meetings.
+ Interface with regulatory authorities as needed.
+ Responsible for key decisions around selecting clinical study design, types of clinical sites to optimize data collection, and overall clinical message of 510(k)s or other regulatory submissions.
Personnel Management:
+ Oversee and manage a global team of 8-10 members.
+ Provide leadership and maintain a respectful and supportive environment.
+ Offer guidance and support to direct reports.
+ Identify and create career growth opportunities.
Compliance:
+ Comply with FDA regulations, other regulatory requirements, company policies, and procedures.
+ Maintain positive and cooperative communications with all levels of employees, customers, contractors, and vendors.
**Required Qualifications**
+ Master's degree in health sciences, biostatistics, biological sciences or related field or an equivalent combination of education and work experience.
+ Minimum 10 years in clinical research for a medical device or pharmaceutical company.
+ Preferred experience in infectious diseases areas for both pre-market and post-market approval clinical trials.
+ Progressive leadership experience in functional area or related field.
+ A solid knowledge of clinical biostatistics and applicable clinical trial regulations both US and OUS is required for this position
+ Demonstrated leadership/management skills with respect to achievement of company goals and objectives.
+ Must possess strong oral and written communication skills.
+ Good interpersonal skills.
+ Skillful in formulating strategies, tactics, and action plans to achieve results.
+ Ability to work in a fast-paced environment.
+ Must be adept at working across cross-functional teams.
+ Ability to work well under pressure and maintain positive, enthusiastic attitude.
+ Able to travel 25% on average may be required.
+ 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.
**Preferred Qualifications**
+ Doctorate Degree MD or PHD
**Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:** www.abbottbenefits.com (http://www.abbottbenefits.com/pages/candidate.aspx)
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. 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.
The base pay for this position is $127,300.00 – $254,700.00. In specific locations, the pay range may vary from the range posted.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email corpjat@abbott.com
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