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Baxter’s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
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Join us at the intersection of saving and sustaining lives— where your purpose accelerates our mission.
Position Summery
The Global Clinical Research Lead (CRL), Med Del/Acute, leads the clinical research strategy for segments of the Med Del/Acute business The CRL will work closely with the Acute Therapies Global Medical Affairs team and commercial organization to define the data / evidence needs in order to bring new products successfully on the market, gain market share, develop markets further and sustain products on the market on a global base. In addition, the CRL will work closely with the rest of the Med Del/Acute MA team and CRL, Med Del to ensure coverage of the clinical research needs across the new combined GBU. The role will define and implement the most efficient ways of gathering data including working closely with the Health Economic expert to gain Health Technology endorsements, higher reimbursements, and support value-based selling (incl risk share). This role will participate in product development teams to drive the clinical and evidence data generation strategy, delivery of clinical and economic research needs to explore-expand new medical use or markets. This role is responsible for developing study strategy, study synopsis and in addition he/she will be accountable to oversee the execution of the clinical protocols and execution of the related studies. He/she takes ownership of clinical research trial results. The Clinical Research lead may support the evaluation of Investigator Initiated Studies (IIS) proposals, data capture and data collection results and initiates publication plans according to the global business and scientific need as integral part of the evidence generations plans for the products as part of the clinical strategic plan for product lifecycle management.
Reporting Relationship
The Global Clinical Research Lead reports into the Sr. Medical Director/Head, Global Clinical Research within the Worldwide Medical and works closely with the Global and Regional Medical Affairs, Clinical Operations and commercial leaders of the Med Del/Acute Therapies segments.
Key Responsibilities
Developing a clinical strategy to effectively and efficiently support the global evidence generation strategy (GEGS) for Acute Therapies.
Cross-functional engagement with Medical Affairs, Clinical Operations as well the Commercial Leadership globally and with key geographies to create the evidence generation strategies that support the registration, launch and market adoption and maintenance on the market for products within the Acute segment and potential other segments of Med Del/Acute business.
Building together with the Health Economic expert the evidence plans to achieve best value-based selling opportunities (including Health Technology recognition)
Working closely with the Global Medical Affairs and regulatory team ensuring the necessary evidence is available meeting pre- and post-market requirements in all global jurisdiction chosen by the commercial team of Baxter in the most efficient way.
Ensuring innovative, effective study designs and real-world evidence ways of data collections are chosen in the most efficient way to achieve the goals in the GEGs.
Accountable to oversee the execution of the clinical protocols and execution of the related studies in partnership with the Strategy and Delivery team
Evaluating and implementing the most cost-effective way of data generation together with internal and external partners, identify and support KOL and HCP relationships.
Working closely with the publication strategy as well the scientific communication plans, compromising training of sales organization and leveraging available evidence in value-based sales
Building the community of practice including cross-functional leadership to establish strong thought leadership globally supporting Baxter’s core technologies
Qualifications
• Strong leader and strong communication skills
• Experience with scientific protocols, data interpretation and clinical study reports.
• Comprehensive knowledge of Federal Regulations, Good Clinical Practices (GCP) and electronic
common technical document (eCTD) requirements
• Strong working knowledge of the medical/clinical requirements related to EU MDR
• Effective management, interpersonal, negotiation, and problem-solving skills.
• Ability to make rapid decisions and take ownership/accountability for key strategic drivers.
• Proven track record of problem solving and risk management across portfolio programs
• Experience working in a matrix organization and building collaborative relationships across multiple
research and business functions with both internal and external stakeholders.
• Ability to communicate ideas and energize others to accomplish challenging goals and objectives.
• Ability to work with scientific and clinical professionals within a team, as well as working in a cross-functional product development setting.
• Ability to manage multiple priorities while maintaining performance.
• Good organizational skills and excellent written and verbal communication skills.
• Knowledge of Baxter portfolio is helpful.
Education and/or Experience
• Minimum Master, PhD, MD or equivalent degree, preferably with speciality training, (e.g. intensive care unit specialist, general surgery, internal medicine, nephrology) or equivalent training or
experience
• Minimum of five years of Clinical Research experience.
• Minimum of five years of applicable global industry experience in a biotechnology or pharmaceutical company
• Real World Evidence and health economic/outcome research training and experience
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
EEO is the law - Poster Supplement
Pay Transparency Policy
Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.
Recruitment Fraud Notice
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