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Sr. Director Medical, Scientific and Clinical Affairs

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 113,000 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 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 (https://www.abbott.com/corpnewsroom/strategy-and-strength/tackling-stude...) student debt program and FreeU (https://www.abbott.com/corpnewsroom/strategy-and-strength/college-degree...) 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 Infectious Disease Emerging Markets, IDEM business unit is part of Abbott Rapid Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions.

The position is within our IDEM BU and is member of the senior leadership team. Oversight and leadership over all of the division’s Medical, Clinical and Scientific activities. Establish vision and strategy for the division’s platforms and execute upon strategy to support the division’s long-range plan and beyond.

Ensure a properly gaited product launch cadence so that products are developed and commercialized, including achievement of product claims and regulatory approvals, to drive increases in IDEM market share.

This position reports directly to the VP, IDEM and ensure efficient and effective management of the Medical, Scientific and Clinical Affairs functions including P&L. Member of the IDEM Executive staff responsible for ensuring the Division meets sales and margin performance goals, compliance with global regulatory agencies and ensuring compliance with systems, procedures and ensuring management structures are in place to meet the goals in an ethical and legally compliant manner.

This role will also lead a clinical operations and medical & scientific teams.

This job description will be reviewed periodically and is subject to change by management.

**RESPONSIBILITIES:**

+ As a leader of a Global R&D team, this role requires a strong commitment to understanding leading practices in product development processes, clinical program management and structures and leading teams to these practices.

+ Excellent leadership and communication style with ability to influence stakeholders, peers across the business.

+ Lead team to meet deliverables and hold self and team accountable

+ Execution and delivery of products on time for commercial launches.

+ Lead Clinical team by providing clinical strategy for trial design and outcomes, clinical relevance.

+ Drive best practice clinical trial management, and execution, data monitoring, data design, statistics technical report writing and reporting.

+ Provide leadership of the Medical and Scientific teams to ensure alignment of clinical practice with product design, development, trial and executive.

+ Provide guidance and leadership for Medical and Scientific teams in building scientific thought leaderships, KOL’s advisory board ensuring external impact to product development strategy and executive of our new product launches.

+ Key leadership role in NPI process and drives stage gate discipline and compliance.

+ Responsible for compliance with applicable Corporate and Divisional Policies and procedures.

+ Evaluate new technologies for potential acquisition or internal funding/development.

+ Develop regulatory and clinical pathways for early stage promising technologies.

+ Influence and work with clinical/regulatory staff to outline specifics of clinical trial design.

+ Influence and interact with FDA and international regulatory bodies in regulatory submission processes, response to inquiries, clinical study results, agency inquiries, etc.

+ Work with U.S. and OUS marketing staff to enhance product launches through effective utilization of clinical study results.

+ Design and deliver training for commercial organization to enhance and increase influence with customers, health care professionals and key opinion leaders.

+ Develop and enhance economic and cost-effectiveness models for reimbursement during the regulatory phase of device development.

+ Represent the division in interactions with health care professionals in symposiums, professional meetings, etc.

+ Design and continually improve effectiveness of commercial organization and clinical affairs organizations through development of disease detection programs, education of physicians, expanding therapeutic options.

+ Leverage division business with other Abbott business to enhance business growth opportunities for Abbott.

+ Oversight and leadership over all of the BU division Research and Development activities. Establish vision and strategy for the division’s platforms and execute upon strategy to support the division’s long-range plan and beyond.

+ Accountable for the successful research, development and maintenance of key assay/system development knowledge and application processes

+ Establish, monitor, and achieve R&D metrics for the division, including time to market, spend, quality, and customer acceptance.

+ Direct Clinical Research Managers to ensure that clinical studies that meet user needs and regulatory requirements are conducted.

+ Manage clinical operations by developing; mentoring; and effectively delegating.

+ Effectively communicate; through the planning and execution of meetings and presentations; project goals; milestones; and updates; to senior management and other functional areas; and regulatory authorities.

+ Develop and implement training programs to ensure compliance with relevant FDA and international regulations and ensure adherence to ICH/GCP guidelines.

+ Monitor training effectiveness by assessing trends in audit observations and drive continuous improvement initiatives by developing new training activities; as appropriate.

+ Negotiate contracts with investigators; vendors; and CROs.

+ Provide compliance guidance on the conduct of clinical research division-wide; for developing and overseeing a quality training program and for compliance in all audits of the Clinical Research organization.

+ Represent the Division's clinical research programs at cross-functional meetings; FDA meetings; FDA

+ Determine system OEM collaborators, foster negotiations, and maintain key partnerships as related to the business’ platform development and manufacturing.

+ Responsible for ensuring that the business develops and produces products that meet the highest standards for quality and accomplishes this in compliance with all applicable regulatory requirements.

+ Function as key member of the Abbott R&D leadership network, representing Abbott Rapid Diagnostics on the Scientific Governing Board. Represent R&D within the business unit working with other functions to achieve business plans.

+ Ensure that sound scientific and technical knowledge and capabilities are recruited and retained.

+ Provide direction for improvements to the Design Control policies and practices by maintaining and updating the Design Control Systems training function and subject matter.

+ Lead internal innovation initiatives to assure organic growth of new ideas and identification of new opportunities to fuel the product pipeline.

+ Develop R&D goals and oversee execution of multiple research and development projects and product support activities. Establish resource needs including staffing requirements.

+ Ensure all R&D activities follow regulatory requirements including FDA; and regional regulatory agencies in APAC, LATAM and EEMEA.

+ Develop and implement the R&D budget for all projects; headcount and capital expenditures. Accountable for the full R&D cycle (discovery to product launch) of both reagent and instrument products in the IDEM business unit through the successful and timely of management goals; milestones and tasks.

+ Advisory Committee meetings and in discussions with senior management and trade meetings.

**BASIC QUALIFICATIONS | EDUCATION:**

+ Incumbent should possess superior expertise in Life Sciences or Engineering acquired through attainment of PhD or MS/PhD from top tier university.

+ Expertise in Lateral flow systems development including hardware/systems engineering, software development, reliability engineering, assay development, and design transfer.

+ Execution in Clinical strategy development and execution of compliant programs that are aligned touseroutcomes.

+ Comprehensive understanding of Lateral Flow regulatory environment with the ability to incorporate that knowledge into strategic R&D business plans.

+ Bachelor of Science in biological or medical science preferred. Master's Degree or higher is desirable

+ 10-12 years of R&D experience with a background in the medical diagnostic industry

+ Demonstrated working knowledge of design controls, QSR and all relevant regulatory requirements for the design, development, and commercialization of medical diagnostic technologies

+ Demonstrated expertise in market dynamics regarding competitive advantage, procedures, new markets and technologies

+ Proficient medical, scientific and clinical understanding of product and disease state clinical relevancy.

+ Preferred: Clinical Laboratory Certification MT(ASCP) or CRA (CCRA)

+ Knowledge of regulations and standards (GCP) affecting IVDs and Biologics required

Apply Now (https://www.jobs.abbott/us/en)

+ * Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

+ **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 and @AbbottGlobal

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

Sr. Director Medical, Scientific and Clinical Affairs

Full time
Lake Forest, IL

Published on 09/18/2022

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