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Global Medical Director, Clinical Development Strategy Lead- Nutrition

Req #: 180003OY_en
Location: Deerfield, IL US
Job Category: GST Doctors
Date Posted: 3/16/2018 12:21:14 PM
Baxter International

Description

Every day, Baxter touches the lives of millions of patients and providers worldwide who rely on our essential hospital and renal products and services. You’ll find Baxter’s products and therapies on nearly every floor, in almost every hospital worldwide, in clinics and in the home. Baxter’s employees are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care. Our commitment to our mission means we are there when patients and healthcare professionals need us, during the critical moments that matter most.

We are looking to grow our clinical team as our clinical study volume increases.  This medical director for clinical will be reporting into the VP of Global Clinical Development.  Under the guidance of the VP the Clinical Development medical director will lead the development and conduct of clinical trials of new products, product line improvements, and product line extensions to demonstrate safety and efficacy to satisfy regulatory requirements and commercial needs. They will also be involved in post market studies as needed.
 
The Medical Director will be responsible for providing clinical leadership and strategic input into three different areas: Nutrition, Medication Delivery and Pharmaceutical businesses.   He/she will demonstrate clinical knowledge for the entirety of a product line with the ability to offer guidance for product support and product development.  This individual will partner with Marketing and Medical on setting global clinical strategies.  Position 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 teams on core teams within product development and life cycle management initiatives.   Position will be clinical lead for area assigned working with cross functions.
 
As such, this person will provides leadership and coordination for the Clinical team by acting as the strategic point person for areas of responsibility as it relates to clinical development that support Baxter top projects.
 
  • Partnering with Medical on creation of Evidence generations plans for the products and where clinical will be accountable.
  • Formulating clinical development plans that encompasses medical affairs, regulatory, HEOR and commercial inputs
  • Leading the design of study concepts, synopsis and clinical protocols as well as partnering with cross functions and clinical operations on executing on studies
  • Leading interactions with regulatory agencies globally as it pertains to clinical studies
  • Input into clinical study reports and submissions of data.
  • Identifying and assisting in recruiting qualified investigators and institutions
  • Assist in providing medical and scientific direction on clinical matters affecting the preparation and submission of timely and sound information to the regulatory authorities
  • Monitoring studies to ensure compliance with protocol and integrity of data, analyzing results and reviewing medical section of regulatory submission
 
 

Qualifications

 

  • 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
  • Ability to operate in complex matrix structure
  • MD (an Internist, Hospitalist or General Practitioner) with a strong hospital background with Minimum 10 years of clinical research experience with  minimum 5 years Industry experience in biotech or pharmaceutical company preferred in pharma drug development or generic drug development
  • Strong clinical trial experience
  • Preferably someone with Nutrition clinical trial experience in particular PN.
  • Recent or ongoing work in industry clinical position and experience in clinical development of new products, drugs and/or devices is required.
  • Basic knowledge of HEOR related activities is desirable as well
  • Comprehensive knowledge and understanding of Federal Guidelines, Good Clinical Practices (GCPs), electronic CTD required and applicable country/region requirements
  • Ability to expand knowledge and adapt to an increasingly complex environment.
  • Attention to detail and excellent verbal/written communication skills.
  • Excellent presentation, interpersonal and organizational skills required.
  • Knowledge of Baxter products, including device and competitive products is helpful.

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.

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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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