Associate Director of Clinical Affairs
Baxter International Inc. develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.
- Leads/directs domestic and global clinical operations strategy and implementation to achieve clinical submissions and timely, cost effective health authority approvals for assigned business or product lines.
- Facilitate and contribute to clinical development strategies for Renal product development projects.
- Manage clinical operations personnel including recruiting, hiring, performance reviews, development, and project assignments. Provide direction and training to staff.
- Risk Management ? Assess risk of achieving study deliverables and identify mitigations.
- Select and oversee external vendors including contract research organizations and Central and Core Laboratories
- Oversee development of clinical trial budgets, project plans and timelines for each clinical study/program and manage the project to those commitments. Oversee the management of the budget preparation, tracking and forecasting for clinical studies.
- Collaborates with other managers to establish and implement divisional policies to assure ongoing compliance with clinical requirements.
- Collaborates with international colleagues to develop effective global strategies for clinical studies.
- Responsible for conduct of studies in compliance with Clinical Affairs policies and procedures, US Code of Federal Regulations, EU, and ICH guidelines and in support of global business objectives. This includes ensuring the appropriate infrastructure, including policies and procedures are in place to meet clinical quality system standards
- Demonstrated leadership skills, both in supervising direct reports as well as defining strategies for efficient study execution.
- Solid basis in scientific approach and an ability to deal with in-depth technical information from a variety of disciplines and foster a high degree of scientific credibility with product development teams and external parties.
- Advanced interpersonal skills and a demonstrated ability to manage conflict situations.
- Excellent oral and written communication skills.
- Established credibility and reputation within the profession.
- Management experience and a demonstrated record of responsible actions consistent with the values of the business.
- Experience in effective collaboration with global colleagues across businesses and functions and with internal and external collaborators.
- Ability to manage multiple studies at one time across multiple regions of the world.
- Advanced scientific degree (or demonstrated equivalent) required. Extensive clinical trial experience in a pharmaceutical, biotech or medical device company. Minimum of 8 years clinical research experience. Experience managing a staff, budget and concurrent multiple projects. Global experience highly desirable.
Baxter provides its employees with comprehensive compensation and benefits.To view other opportunities at Baxter and to learn more about the company, please visit our Web site at http://www.baxter.com/about_baxter/careers. EOE M/F/D/V.
If interested, please apply online at http://track.tmpservice.com/ApplyClick.aspx?id=838279-1792-8075
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