Medical Director
Westlake Village, CA
Req ID 46782BR
Business Title
Medical Director
Business
BioScience
Sub-Business
Research & Development
Country
US
State/Province
California
Location of Position
Westlake Village, CA
Shift_
1st
Job Description
The incumbent will participate in global activities to assure that scientific advisory boards, concept sheets, protocols, interim clinical study reports, expert reports and all other documents to support regulatory submissions occur on time, within budget and are of high quality. The incumbent will assist in the development of study designs, timelines and budgets in collaboration with other members of the Therapeutic Area (TA), other functions within Clinical R&D and Project Management.
•Contributes to the development of the clinical strategies for new and existing BioScience products.
•Assists in the development of general investigational plans, concept sheets and clinical protocols.
•Works closely with Global Regulatory Affairs in the development of documents to support regulatory submissions.
•Participates in conference calls and assists in the preparation of presentations to regulatory agencies, as requested.
•Provides input to and coordinates development of study specific documents including Investigator Brochures (IB), statistical analysis plans, data management plans, CRFs and publications.
•Provides relevant information to Clinical Scientific Affairs to support the compilation of clinical study reports, expert reports and publications.
•Identifies key opinion leaders in the Therapeutic Area and cultivates their working relationship with Baxter as scientific consultants or clinical investigators.
•Arranges and helps to conduct meetings of scientific and clinical advisors.
•Assists in the preparation of yearly budgets for clinical studies performed within the TA and monitors performance to budget.
•Negotiates and maintains timelines for studies with other Clinical R&D functions and monitors performance to timelines.
•Supports commercial functions of Baxter by providing scientific background and advice.
Job Requirements
The incumbent must demonstrate the ability to interact with individuals and organizations of diverse backgrounds, both within and outside Baxter BioScience, including clinical investigators, contract research organizations (CROs), clinical investigators and regulatory agencies. The incumbent must develop a keen understanding of study design principles and key study endpoints unique to the TA.
The incumbent must be fluent in English, both verbal and written communication. This position requires an M.D., with practical experience in the biological sciences and clinical research. Two years of pharmaceutical industry experience, preferably in the field of Hematology and related disciplines, 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.
