Medical Director, Clinical Strategy - Renal
Medical Director, Clinical Strategy - Renal
Baxter International Inc.
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.
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 the 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 provide leadership and coordination for the Clinical team by acting as the strategic point person for areas of responsibility as it related 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 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 communications 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.
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.