Associate Clinical Scientific Manager

Overview

Job summary:

The Associate Clinical Scientific Manager (ACSM) fulfills two key functions within the Strategic Business Unit (SBU) for Autoimmunity in San Diego. This position plays a crucial role in promoting scientific understanding of our assays and developing content to promote their value to our customers. The ACSM coordinates internal resources to drive resolution of complex customer product investigations, resolves technical issues not related to complaints to achieve affiliate and customer satisfaction, and interfaces within and outside Werfen, including responsibility for effective technical communications, reporting, and presentations.

The ACSM will also play a key role in supporting scientific studies.

• Scientific Education Strategy: Develop and execute comprehensive scientific education strategies and programs. Collaborate with the SBU Marketing team to align education initiatives with business objectives. Create customer-focused educational campaigns for existing Werfen products or products in development, to be executed with commercial teams. Create content for internal Werfen Autoimmunity teams to ensure understanding of basic concepts and up-to-date scientific developments.
• Material Creation: Ensure effective and engaging clinical materials, presentations, and resources for Werfen employees and external stakeholders to enhance understanding of Autoimmunity solutions and their clinical applications. Create clinical material to support customer-facing applications and commercial teams to enhance understanding of autoimmunity to effectively support customers.
• Clinical On-market Escalated Support: Support escalated investigations for key Werfen stakeholders (affiliates and customers, when applicable) in managing inconclusive or seemingly unsupported clinical scientific outcomes, including from external quality programs. Review escalated complaints with a cross-functional team, direct internal investigations, and communicate status and outcomes (written or live) with global affiliates and customers.
• Commercial Partnership: Assist Marketing and Affiliate teams in clinical discussions and presentations with potential clients, healthcare professionals, and laboratory personnel. Provide scientific expertise and address queries to facilitate successful commercial efforts. Participate in direct discussions or meetings with laboratorians and clinicians to provide expertise and guidance related to clinical or product topics.
• Clinical Market Intelligence: Stay abreast of latest advancements and research developments, including competition. Analyze clinical and scientific trends to ensure the company remains at the forefront of scientific innovation.
• Clinical Awareness: Increase clinical awareness of Autoimmunity diseases and the importance of accurate and timely patient diagnosis. May work directly with patient advocacy groups and global autoimmune initiatives.
• Guideline Evaluation: Evaluate clinical guidelines related to our products and solutions at an international level and help disseminate them throughout the company, among the Technology Center and affiliates. Regularly review evolving international guidelines for diagnosis and treatment of autoimmune diseases and participate in guideline committees when possible.
• Compliance: Comply with applicable SOPs, ISO, FDA, and other Quality System regulations, as well as Environmental Health & Safety, Human Resources, and other regulatory policies.
• Company Values: Demonstrate company values in quality of work and working relationships.

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

This position requires extensive collaboration and partnership with teams:

• Marketing & Global Systems Support
• Product Complaints Group
• R&D teams, including Manufacturing Technical Support (MTS)
• Regulatory Affairs
• Manufacturing, Operations & Logistics
• Global Affiliates & Distributors
• Quality Teams (QA, QE, Quality Product Support, Post Market Compliance, Document Control)

Education: Master’s Degree, or equivalent, in a…