Sr Director, Medical Affairs

Waters Corporation•San Diego, CA

1d•Hybrid

About The Position

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.

Requirements

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 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, )
Experience in program management and in a customer facing role 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
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 managing clinical flow cytometry laboratory operations and laboratory personnel
Strong organizational skills with ability to build high-performing teams
This position will require travel up to 30% as needed to support organizational goals
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
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

Nice To Haves

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 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, )
Experience in program management and in a customer facing role is a plus
Experience in management of clinical and laboratory-based teams, leading teams remotely and managing projects effectively across geographical sites.
Board certification in Hematopathology, with extensive experience and a record of scientific achievements in flow cytometry, cell sorting, and molecular biology is preferred

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