Medical Director - Acute
DescriptionMedical Director - Acute
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.
The Medical Director will participate in the development of the Global Business strategy to explore-expand new medical use or markets. This Medical Director will provide Medical perspective and expertise in the therapeutic applications of products and will play a key leadership role in the review and oversight of Investigator Initiated Trials globally. The Medical Director will also build the scientific support and foundation and KOL network for the launch of products. The Medical Director is accountable and takes ownership of clinical research trial results and critically evaluates Investigator Initiated Studies (IIS) proposals. This includes responding to adverse effects surfaced by internal or external quality reviews, determining if corrective action is required as well as directing, managing and ensuring corrective actions are applied successfully. The Medical Director will need experience with clinical trials as well as sound grounding in Biostatistics and Regulatory Affairs to support the Therapeutic Area Leader activities, as needed, in clinical development including label changes, evaluation of product complaints and adverse events in conjunction with these specialty functions. This Medical Director will need to develop and maintain strong scientific and medical relationships with Key Opinion Leaders (KOL’s). Works with sales and marketing to identify KOL’s and supervise the educational and informational priorities for the therapeutic area.
Essential Duties & Responsibilities
- Act as Medical Monitor for clinical research studies. Capable of developing communications plan, including publication plans for therapeutic area.
- Lead the development and implementation of a Medical Affairs clinical and education strategy. Drive the development of rational strategic plans for future clinical studies
- Continuously develop and maintain "state of the art" level of knowledge as to developments and trends in medical sciences, especially in the designated therapeutic areas.
- Provide expertise related to the evaluation and reporting issues and adverse events in conjunction with pharmacovigilance, as directed by the Therapeutic Area Leader. Including the review of all adverse clinical consequences or complaints that could have led to an adverse clinical consequence and determine if corrective actions are necessary.
- Strengthen relationships and develop new relationships with KOL’s in business selected therapies segments.
- Identify, qualify and develop KOL’s based on their scientific and professional expertise
- Understand core scientific literature addressing clinical applications and safety of our products and be prepared to utilize this information in response to questions from KOL’s.
- Creates and encourages an environment that stresses open, candid, and timely feedback relative to performance.
- Continuously develop knowledge of regulatory, pharmacovigilance, and quality assurance requirements in alignment with Baxter Global Business Practice Standards.
- Ensure compliance with all Business Policies and Guidelines in accordance with the OIG (for US staff).
MD required with specialty training (intensivist with acute renal replacement therapy experience or a Nephrologist with ICU experience) or equivalent training or experience
- At least 10 years total experience. Minimum 5 years related clinical or regulatory experience,Ideally more than one year of ICU experience.
- Solid knowledge of GCP rules and regulations.
- Minimum of 5 years of applicable industry experience in a biotechnology or pharmaceutical company
- Excellent leadership capabilities; teamwork oriented; interested in working in a multicultural and cross-functional environment.
- Strong management skills; decisive; resourceful
- Well developed interpersonal skills; strong in providing education on complex scientific/clinical issues in a crisp and clear manner both to a peer and larger audience.
- Excellent verbal and written communication skills, public speaking and teaching skills, Strong Microsoft Office skills required·
- Maturity, confidence and credibility to advise and influence senior management
- Willingness to travel approximately 20 – 30% of time.
- Strong business acumen and impeccable integrity
- Previous pharma / biotech industry experience preferred.
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.