Global Medical Director, Clinical Development Strategy Lead- Nutrition
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.
- 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
- 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.
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.