Clinical Director - PhD/PharmD - 160006QH
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 generation 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.
We are looking to grow our clinical team as our clinical study volume increases. This medical/clinical 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 and HEOR related work.
He/she will be responsible for providing clinical leadership and strategic input in one or more of the following therapeutic areas: Renal Medicine, Nutrition, Surgery, Anesthesia or Critical Care. 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. 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 therapeutic area experts on core teams within product development and life cycle management initiatives.
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 relates to daily operations, clinical development, physician relationships, quality initiatives and system-wide initiatives that support Baxter top projects.
Formulate clinical development plan, ensure integration of clinical plan and strategy with the needs of medical affairs, regulatory, commercial .and other stake holders.
Formulate clinical development plan, ensure integration of clinical plan and strategy with the needs of medical affairs, regulatory, commercial and other stake holders.
Prepare clinical protocol and review investigator brochure.
Address and resolve medical/safety/eligibility questions from participating clinical trial sites.
Will participate in writing regulatory submissions.
Participate on core teams as clinical leader on key products.
Provides therapeutic input into due diligence projects.
Able to liaise effectively with multiple internal functions;: Clinical Operations, Biometrics, Medical Affairs, Regulatory Affairs and Commercial teams.
Organizes monthly reviews of study concepts/synopsis across therapeutic areas.
Will monitor studies to ensure compliance with protocol and integrity of data, analyze, results and prepare the medical section of regulatory submissions.
Develop and maintain relevant key thought leader relationships and may service as the clinical lead for advisory meetings as needed.
Assist in providing medical and scientific direction on clinical matters affecting the preparation and submission of timely and sound information to the regulatory authorities.
Review and support product labeling and advertising activities as needed.
Attend appropriate scientific meetings to maintain awareness of research activities in area of expertise.
Assist in selecting external vendors including research organizations, CRO's and central laboratories.
Assist in providing medical and specialty expertise for safety surveillance of clinical studies.
Interact with regulators worldwide as necessary.
Education and/or Experience:
MD, PharmD or Equivalent scientific degree with Minimum 10 years of clinical research experience. Minimum of 6 years Industry experience in biotech or pharmaceutical company preferred.
Preference to training in internal medicine, surgery, pediatrics and/or knowledge in renal medicine. Other medical specialties acceptable.
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 outlines 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.
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.
EEO is the Law
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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 email to Corporate_Staffing_Deerfield@baxter.com or call 877-229-4748 (877-BaxHR4U) and let us know the nature of your request along with your contact information.
Job: Clinical Affairs
Primary Location: United States-Illinois-Deerfield
Organization: Life Sciences & Operations