The Sr. Director of Medical Affairs will lead the department and have supervisory responsibilities over internal medical laboratory and other medical affairs teams. These teams will contribute to strategy, evidence generation, and post-market medical surveillance for Waters Biosciences Clinical portfolio of products. Management of these teams requires technical expertise in flow cytometry panel and LDTs along with depth in laboratory operations, hematology, hematology-oncology, and various guidelines and regulations.

Responsibilities:

• Provide leadership for overall Medical Affairs and Clinical Affairs teams 
• Provide leadership for clinical projects in collaboration with both internal and external stakeholders to further Biosciences business goals and objectives
• Develop and manage the team of laboratory professionals who work in the Biosciences Medical Laboratory, to ensure timely and productive services as requested or required
• Develop and manage Medical Affairs team to ensure effective and compliant clinical products, performance evaluation studies, and clinical trials to support regulatory and commercial goals
• Develop and manage the Clinical Affairs team in support of clinical site selection, study design and execution of clinical trials and analytical validation studies to support regulatory and commercial goals. 
• Oversee internal medical input into verification and validation studies for clinical products 
• Develop and manage clinical study managers and clinical research associates (monitors) supporting clinical study execution 
• Develop strategic relationships with key customers to advance supporting evidence generation of Biosciences products
• Ensures global compliance and collaboration with and support internal Clinical Development and Operations teams and Field Facing Medical Affairs functions
• Collaborate with key stakeholders and participate in the Clinical Platforms Program Management to provide clinical and scientific guidance for product development
• Provide vital clinical assessment for plans and projects originating within the Waters Biosciences
• Drive evidence generation and publication planning for marketing collateral to support clinical products
• Ownership of on-time quality assessments, medical device reporting and health risk assessments to the FDA and other regulatory bodies
• Provide subject matter expertise into design of clinical trials for medical device development and submission to the FDA and other regulatory bodies
• Identify and communicate key development goals and strategic initiatives to support the business needs and requirements
• Participate in business development activities as requested, to identify market

gaps, unmet medical needs, and opportunities to support key business objectives

• Provide clinical strategy for clinical and CDx programs and interact with external CRO and Pharma/Biotech partners and ensure compliance.
• Provide subject matter expertise to the organization and serve as a mentor to junior associates

Qualifications:

• Ability to credibly represent Biosciences Business or function to external