Senior Director Medical Affairs

BD • Milpitas, CA

387d • $181,400 - $326,500

About The Position

The Senior Director, Medical Affairs and Clinical Execution at BD is responsible for leading clinical and research projects, managing teams in clinical operations and medical affairs, and providing strategic guidance on clinical products. This role requires extensive expertise in clinical hematopathology, immunology, and advanced flow cytometry, along with experience in clinical trial design and regulatory submissions. The Sr. Director will collaborate with internal and external stakeholders to enhance product recognition and support evidence generation for BD Biosciences' clinical portfolio.

Requirements

• Requires an MD or MD/PhD, with specialization in Laboratory Medicine.
• Board certification in Hematopathology, with extensive experience and a record of scientific achievements in flow cytometry, cell sorting, and molecular biology is preferred.
• Minimum 5-10 years of experience in a regulated healthcare industry.
• Prior Medical Affairs experience.
• Prior experience in clinical trial design, operations and execution.
• Prior experience in clinical site engagement and clinical sample acquisition.
• Experience in program management is a plus.
• 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 driving life science innovation as indicated by publications, patents, funding history and new product launches.
• Strong communication and presentation skills with an ability to translate complex biological concepts into actionable business options.
• Ability to credibly represent a BD 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 trial design and execution: CTMs, CRAs, etc.
• Strong organizational skills with ability to build high-performing teams.

Nice To Haves

• Experience in program management is a plus.
• Prior experience in a customer-facing role is a plus.

Responsibilities

• Provide leadership for clinical and research projects in collaboration with both internal and external stakeholders to further BDB business goals and objectives.
• Develop and manage the team of laboratory professionals who work in the BDB Medical Laboratory, to ensure timely and productive services as requested or required.
• Develop and manage the Medical Affairs and clinical execution team, to ensure effective and compliant clinical products and clinical trials to support regulatory and commercial goals.
• Develop and manage clinical trial managers and clinical research associates (monitors) supporting clinical trial execution.
• Develop strategic relationships with key customers to advance the recognition, utility, and supporting evidence of BDB products.
• Collaborate with key stakeholders and participate in the Clinical Platforms Program Management to provide clinical and scientific guidance for product development.
• Engage customers to enhance the customer experience and facilitate communication of feedback to enable product improvements.
• Provide vital clinical assessment for plans and projects originating within the BDB Platforms.
• 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.
• Design and execution 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 input to CDx strategy and interacts with external CRO and Pharma/Biotech partners.
• Provide subject matter expertise to the organization and serve as a mentor to junior associates.

Benefits

• Competitive salary range of $181,400.00 - $326,500.00 USD annually.
• Comprehensive benefits package including health insurance, retirement plans, and professional development opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Miscellaneous Manufacturing
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees