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 stakeholders, such as business partners, regulatory authorities, and key customers is required. 
• Possesses a high level of business acumen and organizational savvy, sound professional judgment, and an ability to drive organizational change and serve as a role model within the organization. 
• Strong interpersonal skills are required. Specifically, cross functional collaboration, listening, and negotiation skills are critical. 
• Experience in management of clinical and laboratory-based teams, leading teams remotely and managing projects effectively across geographical sites. 
• Experience managing all functions related to clinical study design and execution: CSMs, CRAs, etc. 
• Experience in managing staff overseeing multiple clinical studies and clinical development programs simultaneously 
• Strong organizational skills with the ability to build high-performing teams. 
• This position will require travel up to 30% as needed to support organizational goals. 
• Requires an MD or MD/PhD, with specialization in Laboratory Medicine, preference for U.S. trained physician
• Board certification in Hematopathology, with extensive experience and a record of scientific achievements in flow cytometry, cell sorting, and molecular biology is preferred
• Minimum 10-15 years of experience in a regulated diagnostic healthcare environment
• Prior experience in clinical trial design, operations, and execution 
• Prior experience in clinical site engagement and clinical sample acquisition  
• Deep understanding of regulations pertaining to U.S. LDT and IVD development, IVDR regulatory experience is a plus
• Deep understanding of CLSI guidelines
• Previous experience managing CAP certification/ involvement with other major organizations (Pathology Online, CLSI, ASH, ICCS, NCCN, ASCO, WHO, etc.)
• Prior experience in clinical study design, operations, and execution
• Experience in program management is a plus
• Excellent command of oral and written communication skills
• Demonstrated ability to work effectively in a large and matrixed organization with multiple stakeholders
• Prior experience in a customer-facing role is a plus
• Proven track record of life science innovation as indicated by publications, patents, funding history, and new product launches
• Strong communication and presentation skills with the ability to translate complex biological concepts into actionable business options.
• Ability to credibly represent Biosciences to external stakeholders, such as business partners, regulatory authorities, and key customers is required
• Possesses a high level of business acumen and organizational savvy, sound professional judgment, and an ability to drive organizational changes and serve as a role model within the organization
• Strong interpersonal skills are required. Specifically, cross functional collaboration, listening and negotiation skills are critical
• Experience in management of clinical and laboratory-based teams, leading teams remotely and managing projects effectively across geographical sites.
• Experience managing clinical flow cytometry laboratory operations and laboratory personnel
• Strong organizationalskillswithabilitytobuildhigh-performingteams
• This position will require travel up to 30% as needed to support organizational goals
• Preferred location in Milpitas, CA. (remote candidates with extensive experience may be considered with regular travel to company location)