Senior Medical Director

Senior Medical Director

Deerfield, IL

Req ID 49807BR

Business Title
Senior Medical Director

Business
Medical Products

Sub-Business
Research and Development

Country
US

State/Province
Illinois

Location of Position
Deerfield, IL

Shift_
1st

Job Description
Summary

The Senior Medical Director is primarily responsible for clinical strategies related to oncology product development programs and sustaining product activities in the Fluid Systems franchise. The Sr. Medical Director is also responsible for preparation of clinical sections for registration and re-registration submissions to regulatory authorities worldwide for marketing approval as well as maintenance of existing product licenses. The Sr. Medical Director participates on strategic teams including the identification of new product opportunities as well as life-cycle management programs. The Sr. Medical Director will provide Medical perspective and expertise in the therapeutic applications of Fluid Systems oncology products. The Sr. Medical Director will provide medical technical perspective to the Business Development and Portfolio Management functions in the identification of potential partnering and internal opportunities. The Sr. Medical Director provides expertise with counterparts in other functional areas such as Manufacturing, Quality, Assurance, Regulatory Affairs, R&D, Legal and Marketing. The Sr. Medical Director develops and maintains strong scientific and medical relationships with consultants as needed to support development programs.
Essential Duties and Responsibilities.

•This section contains a list of the primary responsibilities of the work. The incumbent will perform other duties as assigned.

•Provide medical and scientific direction on clinical matters affecting preparation and submission of timely and sound information to the worldwide regulatory agencies.

•Work with product development and marketing functions to define the requirements and specifications for new products.

•Capable of developing communication plan, including publication plans for the therapeutic area.

•Reviewing and approving documents needed to support products, such as CCSIs, PSURs, SBRs, label updates, etc.

•Drive the development of rational strategic plans for future products and provide strategic leadership to the clinical R & D and medical affairs activities associated with technical support for products in the global market.

•Develop and maintain knowledge as to developments and trends in medical sciences, especially in the designated therapeutic area(s).

•Understand core scientific literature addressing clinical applications and safety of our products and be prepared to utilize this information in response to questions from internal and external customers, including regulators.

•Serve as a consultant to quality and pharmacovigilance functions in the investigation of adverse events and other product-related issues.

•Develop knowledge of regulatory, pharmacovigilance and quality assurance requirements in alignment with Baxter Global Business Practice Standards.

•Collaborate with Clinical Development and Operations in the development and writing of Clinical Trial Concept Sheets and Protocols as well as providing input to investigator's brochure and interim/final Clinical Study Reports (CSRs). Approve final clinical trial protocols, investigator's brochures and CSRs.

•Develop clinical sections of Regulatory submissions for CTAs and CTDs.

•The position of Senior/Medical Director has a worldwide scope and all clinical development activities must comply with Good Clinical Practice (GCP) specifications as practiced in different geographies.

Job Requirements
Qualifications.

•Solid knowledge of GCP rules and regulations.

•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.

•Strong business acumen and impeccable integrity.

•Education and/or Experience.

•MD degree, licensed physician who is Board Certified in Internal Medicine or equivalent training or experience. Additional experience and/or training in oncology is highly desirable.

•Minimum of ten years of medical experience with ten years of medical affairs/clinical development experience; or combination thereof. Experience in a biotechnology, pharmaceutical company or CRO performing most or all of the responsibilities in this position is preferred.

Doing Work that Matters
Baxter provides its employees with comprehensive compensation and benefits. To view additional opportunities at Baxter and to learn more about the company, please visit our Web site at company website. EOE M/F/D/V.