Baxter International Inc. develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.Will provide global medical/clinical leadership for Clinical Affairs. This position is responsible for clinical strategies and for the evaluation of clinical safety related to all assigned projects (drugs and devices). Responsibilities/key accountabilities include:
? Provide medical/clinical expertise and leadership to support the New Product Development (NPD), Product Support, and business development efforts within the Renal Division, including clinical approval of product designs and specifications, clinical input for non-clinical protocols, clinical development strategies, and clinical protocols.
? Medical assessment of clinical safety throughout the development process for drugs and devices.
? Interact with customers, physicians, industry organizations and global regulatory professionals to ensure the safety, efficacy and availability of renal products.
? Function as the medical/clinical representative at regulatory meetings in varying geographies.
? Provide medical and scientific direction on clinical matters affecting the preparation and submission of timely and sound information to regulatory agencies.
? Apply therapeutic expertise to consult with Baxter physicians in Regulatory, Surveillance, and Medical Vigilance Departments regarding patient safety issues.
? Review and approve advertising and promotional materials related to renal topics.
- M.D., Fellowship in Nephrology required
- Minimum of 10 years of experience required, 5 of which must have been in clinical practice and trial design and supervision.
- Pharmaceutical or biotech industry experience desirable
- Expertise in clinical development, investigation and research.
- Working knowledge of global regulatory requirements related to job responsibilities.
- Demonstrated team leadership and management skills, existing relationships with and proven ability to influence renal thought leaders and practitioners.
- Excellent verbal and written communication skills demonstrated through publication and presentation of clinical papers.
Baxter provides its employees with comprehensive compensation and benefits.To view other opportunities at Baxter and to learn more about the company, please visit our Web site at http://www.baxter.com/about_baxter/careers . EOE M/F/D/V.
