Associate Director, Clinical Research
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.
Associate Director, Clinical Research
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 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 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 Plymouth or St Paul, MN location for our Electrophysiology Medical Device business. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.
This role will plan and manage multiple or complex Clinical Affairs Program(s) across all functional areas, within budget and timelines. Represents Clinical Affairs function at Clinical Advisory Board meetings, interactions with Regulatory Agencies, and for evaluation of business opportunities including due diligence.
What You’ll Work On
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
Budgetary responsibility for cost center or Clinical Affairs program. Ensure development of accurate budgets, contract development and execution, payments and tracking of study, clinical evaluation, and/or risk management expenditure as directed by your manager.
Management of personnel development, mentoring and effective delegation to direct reports to meet program goals. Effectively communicate information through the planning and execution of meetings and presentations and present recommendations to senior staff. Manage performance management process for the team.
Accountable for strategy development and execution for specified clinical area.
Effective coordination of all functional areas involved in the clinical program to solve problems and assure progress and timely completion of program goals.
Critical review of vendor proposals and contracts to include potential CRO agreements and medical writers to ensure program success. Financial approval of contracts and expenses at specified level.
Prioritization across teams to ensure strategic goals/milestones within Clinical Affairs are met.
Develops and maintains current, in-depth, relevant functional knowledge (such as scientific, technical and regulatory aspects) of projects in support of the diagnostic area on a global basis.
Builds and maintains relationships with key experts and professional organizations that further the effective development of the product and maximize product potential.
Collaborates with functional management to ensure an appropriate functional spokesperson for the project is identified to interact with relevant stakeholders, including R&D, Regulatory Affairs, commercial management, external experts and professional organizations and regulatory agencies.
Leads and motivates functional area teams to meet key project deliverables and timelines by developing effective technical strategies, and collaborating with functional management to coordinate tactical execution by sub team members and functional organizations.
Drives short- and long-term project success by managing and monitoring the functional components of worldwide projects such that scientific, regulatory, legal, financial, commercial and quality requirements are met in consideration of time and resource constraints as well as environmental uncertainties while operating by and within standardized procedures established within the function.
Uses thoroughly analyzed data, due diligence, and input from internal and external functional experts to drive a rigorous decision-making process that appropriately incorporates underlying assumptions, risks and benefits, probabilities of success, timelines, and resource requirements.
Effectively manages team members and deliverables in times of conflict, uncertainty and crisis, and resolve issues in a timely manner in conjunction with functional management. Fosters creative thinking, innovation, knowledge sharing and reasoned risk-taking.
Ensures appropriate review and refinement of project plans by functional area management and staff.
Clearly communicates project/program recommendations and decisions to various stakeholders within the team, functional areas, R&D, and commercial management.
Appropriately disseminates feedback from governance bodies and the functions to the team and extended organization.
Acts on appropriate feedback from worldwide project team stakeholders and functional management to optimize performance as worldwide project team core team member. Program/development strategy/direct line management and research matrix management - Clinical Affairs representative for worldwide project team.
Daily interaction with Sr. Management in multiple cross-functional areas, including finance, R&D, and regulatory affairs. - Manages internal organization/department within larger Clinical organization in a cross-functional environment. - Responsible for setting direction, creating/managing budget, prioritization, staff management and development.
Required Qualifications
Education: Bachelors Degree in related field OR an equivalent combination of education and work experience
Minimum 10 years Related work experience in clinical research; preferred industry experience in medical device or pharma.
IDE, risk management, and/or clinical evaluation experience required.
Management experience in other clinical operations and/or regulatory affairs positions.
Global experience preferred.
What We Offer
At Abbott, you can have a good job that can grow into a great career. We offer:
A fast-paced work environment where your safety is our priority
Production areas that are clean, well-lit and temperature-controlled
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 health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
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 X @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.