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 Clinical & HEOR. 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 the Renal therapeutic area. We are looking to fill one position supporting Chronic renal area and one to support our Acute renal space. 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 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.
Formulating clinical development plans that encompasses medical affairs, regulatory, HEOR and commercial inputs
Designing study concepts, synopsis and clinical protocols
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
MD with minimum of 5 years Industry experience in biotech or pharmaceutical company preferred.
Preference to training in nephrology, intensivist (acute business) and/or knowledge in renal medicine with experience running clinical studies.
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 (e.g. Federal Guidelines outlined in Title 21 of the Code of Federal Regulations).
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.
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 generat...ion 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.