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Global Clinical Development Lead / Acute Therapies

Req #: 1800003I_en
Location: Deerfield, IL US
Job Category: GST Doctors
Date Posted: 2/8/2018 3:41:40 PM
Baxter International

Description

Global Clinical Development Lead / Acute Therapies

Deerfield, IL


About Baxter
Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-center dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacy automation, software and services.The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.


Opportunity Overview:

Baxter is expanding the clinical team as a result of increased investment in clinical study data generation. The following is a newly created opportunity in the organization:

 

The Global Clinical Development Lead for Acute Therapies will be responsible for providing clinical leadership and strategic input to Baxter’s existing products and expansion into new areas of Acute Renal Critical Care Therapies. He/she will demonstrate clinical knowledge for the entirety of a therapeutic area and all the associated products with the ability to offer guidance for product support and product development.

 

Reporting into the Vice President of Global Clinical Development, the Global Clinical Development for Acute Therapies will lead programs with goals of demonstrating safety and efficacy to satisfy regulatory requirements and commercial needs. They will also be involved in post market studies and HEOR related activities.


This individual will partner with Marketing and Medical on setting global clinical strategies as part of the Evidence Generation plans.


The Global Clinical Development Acute Therapies Lead will participate in product development teams and meet with internal and external experts in developing clinical strategies and related study protocols. This person works closely with Baxter Medical on core teams within product development and life cycle management initiatives. The Clinical Development lead will partner with Clinical Operations on the daily operations of the studies.


As such, this person will provide leadership for the Clinical team by acting as the strategic point person for areas of responsibility as it relates to Clinical Development strategy, Baxter Sponsored Clinical studies, physician relationships as it pertains to the Baxter Sponsored clinical studies that support Baxter Renal Care projects.

  1. Formulate clinical development plan, ensure integration of clinical plan and strategy with the needs of medical affairs, regulatory, commercial and other stake holders.
  2. Prepare clinical synopsis and protocol and review investigator brochure.
  3. Address and resolve medical/safety/eligibility questions from participating clinical trial sites.
  4. Will participate in writing regulatory submissions as it pertains to Baxter Sponsored Clinical studies.
  5. Participate on core teams as clinical lead on key products and partner with Clinical operations.
  6. Provides therapeutic input into due diligence projects
  7. Able to liaise effectively and partner with multiple internal functions: Clinical Operations, Biometrics, Medical Affairs, Regulatory Affairs and Commercial teams
  8. Organizes monthly reviews of study concepts/ synopsis across therapeutic areas
  9. Will monitor studies to ensure compliance with protocol and integrity of data, analyze results, and prepare the medical section of regulatory submissions
  10. Develop and maintain relevant key thought leader relationships as it pertains to Baxter Sponsored Clinical studies and may serve as the clinical lead for advisory meetings as needed.
  11. Assist in providing medical and scientific direction on clinical matters affecting the preparation and submission of timely and sound information to the regulatory authorities
  12. Assist in providing medical and specialty expertise for safety surveillance of clinical studies
  13. Interact with regulators worldwide as necessary.

 

 

Qualifications

Education and/or Experience:

  • MD with Board Certification in Critical Care / Intensivist / ER Medicine with a minimum of 2 years of experience at a healthcare, pharmaceutical or clinical contract research organization
  • Recent or ongoing work in industry clinical position and strong experience in clinical development of new products, drugs and/or devices is required.
  • Comprehensive knowledge and understanding of Federal Guidelines, Good Clinical Practices (GCPs), electronic CTD required and applicable country/region requirements (e.g. Federal Guidelines outlined in Title 21 of the Code of Federal Regulations).
  • Broad scientific, technical and regulatory understanding of most of the functions involved in the development of a device and a pharmaceutical product.
  • Effective management, interpersonal, communication, negotiation, and problem solving skills.
  • Proven track record of problem solving and risk management across portfolios
  • Ability to make rapid decisions and take ownership/accountability for key strategic drivers.
  • Experience working in a matrix organization and building collaborative relationships across a number of research and business functions.
  • Must possess strong knowledge of scientific disciplines and solid knowledge of related disciplines.
  • Possesses highly developed business acumen and deals well with ambiguity
  • Able to communicate complex scientific/clinical issues in a concise and clear manner to a broad range of audiences
  • Must be able to set strategic direction for the organization and broadly communicate the vision.
  • Ability to operate in complex matrix structure
  • Leads through influence rather through organizational power
  • Has executive presence and ability to influence customer and other stakeholders
  • Has broad experience managing key global project and initiatives with known track record of success

 

Equal Employment Opportunity

 

Baxter is an equal employment opportunity employer. Baxter evaluates qualified candidates without regard to race, color, region, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristics.

 

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

EEO is the Law
EEO is the law - Poster Supplement
Pay Transparency Policy

Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.


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